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International NEWS-IN-BRIEF – Medical Devices 2012/05/N001 April 2012LEGIPH@RM International©
LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information©
International NEWS-IN-BRIEF – Medical Devices 2012/05/N001 April 2012LEGIPH@RM International©
LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information©
International Medical Devices Regulatory NEWS-IN-BRIEF – April 2012 – N01
LEGIPH@RM International publishes “International Medical Devices Regulatory NEWS-IN-BRIEF” (IMDRNIB) a newsletter focusing on regulatoryissues of medical devices. LEGIPH@RM International publishes also in French “Info Dispositifs Médicaux” and the “Brèves d’Actualités”.“International Medical Devices Regulatory NEWS-IN-BRIEF” is an electronic-only (PDF) newsletter with links to the sources of information .“International Medical Devices Regulatory NEWS-IN-BRIEF” is published monthly (11 issues per year).
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subscription form, email the completed form to [email protected] or Fax it to +33 (0)970622453. Two ways to pay: (1) bank transfer, (2) cheque Editorial Address: LEGIPHARM International – 4 mail Francois Mitterrand 35000 RENNES – France Billing Address: LEGIPHARM International – 4 mail Francois Mitterrand 35000 RENNES – France Editorial Board: Chairman Bernard-Régis Durand – Editor Thérèse Pierre Contact: [email protected] –Tel +33 (0)299388474 (The office is open Monday through Friday from 9:30 am - 6:00 pm – European Time)
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General: Whilst making all reasonable efforts to provide correct information, LEGIPHARM International cannot guarantee that theinformation and data provided by the IMDRNIB newsletter are accurate. The IMDRNIB newsletter is not intended to provide advicewith respect to any specific matter. Whilst every effort has been made to ensure the accuracy of this publication, it is for generalguidance only and should not be treated as a substitute for specific advice. No warranty of any kind is given with respect to thementioned information and data. Therefore, LEGIPHARM International shall have no liability or responsibility whatsoever no matterwhether it is based on contract, tort or any other legal ground for any inaccuracy, incompleteness, omission, lack of timeliness orany other error of the data and information nor for any computer viruses transferred with the data supplied by LEGIPHARMInternational in the IMDRNIB Newsletter. Decisions based on data and information contained in the IMDRNIB newsletter are thesole responsibility of the user.
Links: LEGIPHARM has checked the links (URL) mentioned in the IMDRNIB newsletter, but LEGIPHARM is not responsible for (1)any subsequent changes to the Web sites after the publication of the IMDRNIB newsletter, (2) any broken links, (3) anyimpossibility to access the mentioned URL of the websites.
Translation: The IMDRNIB newsletter have been prepared for information purposes only. When an English translation is providedby LEGIPHARM, this translation is also for information purposes only. LEGIPHARM is therefore not liable for any inaccurateinformation resulting from the translation. The translation is not a substitute for the original version.
Copyright: © 2012
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Date of Information
Information is sorted by date. These dates may be (1) the date specified in the source document itself, (2) the date of creation of the sourcedocument file, (3) the date of the last modification of the source document file, (4) the date of the emailing of the source document, (5) the dateof the source document specified in the website or (6) the date on which LEGIPHARM has discovered the existence of the source document.
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International Medical Devices Regulatory NEWS-IN-BRIEF
International Medical Devices Regulatory NEWS-IN-BRIEF ................................................................................................ 1
April 15, 2012..................................................................................................................................................................... 1
Brazil – LNE/G-MED America: Medical Devices Approval Process ...........................................................................................1 International ISO: ISO standards updates and medical devices ............................................................................................1
April 14, 2012..................................................................................................................................................................... 1
Europe / European Commission: A new version of the Borderline manual...............................................................................1
April 13, 2012..................................................................................................................................................................... 1
Australia – Therapeutic goods administration (TGA): PIP breast implants – information update ................................................1 Korea – KFDA: Regulations and adverse event reporting......................................................................................................1
April 12, 2012..................................................................................................................................................................... 2
China – Clinical trial: OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions ............................................2
April 11, 2012..................................................................................................................................................................... 2
European Federation of pharmaceutical industries and associations (EFPIA): Industry Perspective on Formulation and PackagingConsiderations – Devices (Integrated Product) Aspects........................................................................................................2
Europe – Official Journal of the European Union: Harmonised standards, electromagnetic compatibility and medical devices ........2 Europe – Official Journal of the European Union: Harmonised standards, radio equipment and telecommunications terminal
equipment and medical devices ........................................................................................................................................2 Europe – European Commission: European Commissioner for Research, Innovation and Science, Ireland, Medtronic and medical
devices..........................................................................................................................................................................3 US – Clinical trials: Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation ....4
April 10, 2012..................................................................................................................................................................... 4
Europe – European Databank on Medical Devices (EUDAMED): Deadline for data on registration of medical devices manufacturers....................................................................................................................................................................................4
Japan – Clinical trials: Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience/PROMUS ................................4 Japan – Clinical trials: Multi-center Study for Stent Graft System for Peripheral Artery ............................................................5 United-Kingdom – Clinical trials: Functional Outcome in Two Types of Total Knee Replacement Surgery for People With
Osteoarthritis .................................................................................................................................................................5
April 10, 2012..................................................................................................................................................................... 5
Australia – Therapeutic goods administration (TGA): PIP breast implants – TGA update...........................................................5 Malaysia – Medical Device Control Division (MDCD) of the Ministry of Health: The Medical Device Act 2012 and the Medical Device
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Authority Act 2012 have been gazetted .............................................................................................................................5
April 9, 2012....................................................................................................................................................................... 6
China – Clinical trials: Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union ...........6
April 4, 2012....................................................................................................................................................................... 6
United-Kingdom – MHRA: Weekly list of Field Safety Notices 2 – 6 April 2012 ........................................................................6
April 4, 2012....................................................................................................................................................................... 7
Europe – Notified Bodies: LGA InterCert Medical and TÜV Rheinland LGA Products become one ................................................7
April 3, 2012....................................................................................................................................................................... 7
Brazil – Ministry of Health: National health products and preference in federal procurement.....................................................7 Australia – Therapeutic goods administration (TGA): Brochure for health professionals about reporting medical device adverse
incidents........................................................................................................................................................................7
April 2, 2012....................................................................................................................................................................... 7
Spain – Spanish Agency for Medicines and Healthcare Products: increasing activated for medical devices ..................................7 Australia – Therapeutic goods administration (TGA): PIP breast implants – Progress review of on-going TGA Laboratory testing
program ........................................................................................................................................................................8 United-Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA): New advice to surgeons about metal-on-metal
total hip replacements.....................................................................................................................................................9 Canada – Health Canada: Medical Device Recall Listings Date April 2012 – June 2012 ...........................................................10 Canada – Health Canada: Revisions made to guidance documents and forms for medical devices –fees...................................10
March 30, 2012................................................................................................................................................................. 11
Australia – Medical technology association of australia (MTAA): Medical technology industry a key to economic growth in Australia..................................................................................................................................................................................11
Australia – Therapeutic goods administration (TGA): PIP breast implants – Information update ..............................................12 US – Food and Drug Administration (FDA): The safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems ......12 Japan – Ministry of health: Regenerative products and medical devices ...............................................................................14 United-Kingdom – MHRA: Weekly list of Field Safety Notices 26 – 30 March 2012.................................................................14
March 29, 2012................................................................................................................................................................. 14
International – International Organisation for Standardisation: An ISO/IEC guide upgrades safety aspects in medical devicestandards ....................................................................................................................................................................14
Ireland parliament: PIP breast implants and the the revision of the medical devices legislation...............................................15 United Kingdom – Health and Safety Executive (HSE) / Medicines and Healthcare Products Regulatory Agency (MHRA):
Arrangements for liaison between the HSE and the MHRA, Medical Devices Division ..............................................................15 Europe - Official Journal of the European Union: Regulation on electronic instructions for use of medical devices ......................16
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March 28, 2012................................................................................................................................................................. 16
United-Kingdom – parliament Health Committee: All providers should offer to replace breast implants which have failed accordingto Health Committee .....................................................................................................................................................16
United-Kingdom – Parliament: PIP Breast Implants and regulation of cosmetic interventions..................................................16
For further information..................................................................................................................................................... 16
US – Food and Drug Administration (FDA): ISO 13485:2003 Voluntary Audit Report Submission Pilot Program ........................17 US – Food and Drug Administration (FDA): New FDA guidance on considerations used in device approval, de novo decisions –
Clinical data, risks, benefits and patient risk tolerance outlined in process............................................................................17 US – Food and Drug Administration (FDA): General issues related to medical devices intended for obese patients ....................18 Europe – European Medicines Agency (EMA): “Explanatory note on fees payable to the European Medicines Agency” and
“Consultation on ancillary substances including blood derivates incorporated in medical devices”............................................18
March 27, 2012................................................................................................................................................................. 19
Europe – European Association for Medical Devices of Notified Bodies: European Medical Device Notified Bodies Statement onEuropean Medical Device Regulatory Regime....................................................................................................................19
Argentina – Ministry of health: Free Hearing aids and cochlear implants and promotion of social integration of deaf children......19 Europe – European Association for Medical Devices of Notified Bodies: Statement on European Medical Device Regulatory Regime
..................................................................................................................................................................................20
March 26, 2012................................................................................................................................................................. 20
United-Kingdom – Parliament: Regulation of medical implants............................................................................................20 International – International Criminal Police Organization (INTERPOL): A fact sheet about pharmaceutical crime......................20 Argentina – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT): A partnership agreement with a
e-commerce leader firm in Latin America to control internet sales of drugs and medical products ...........................................21
March 23, 2012................................................................................................................................................................. 21
US – Food and Drug Administration (FDA): Safety and effectiveness of two transcatheter Atrial Septal Defect (ASD) occluders ..21 Norway – Health directorates: New measures for breast reconstruction ...............................................................................21 United–Kingdom: Weekly list of Field Safety Notices 19 – 23 March 2012 ............................................................................21
March 22, 2012................................................................................................................................................................. 22
China – Sate Food and drugs administration (SFDA): Meeting with European Commissioner for Health and Consumer Policy andDirector General of European Commission DG Health and Consumers..................................................................................22
Brazil – Agência Nacional de Vigilância Sanitária (ANVISA) / National Agency of Sanitary Surveillance: International experts andBrazilian monitoring of orthopedic implants ......................................................................................................................22
March 22, 2012................................................................................................................................................................. 22
Brazil – Agencia Nacional de vigilancia sanitaria (ANVISA): The Agency publishes rules on breast implants ..............................22
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March 19, 2012................................................................................................................................................................. 23
International – World Health Organisation: Effective approaches for strengthening multisectoral action for noncommunicablediseases and medical devices .........................................................................................................................................23
March 16, 2012................................................................................................................................................................. 23
US – Food and Drug Administration (FDA): Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program;Availability ...................................................................................................................................................................23
US – Food and Drug Administration (FDA): Modifications to the List of Recognized Standards ................................................23
Le 15 march 2012............................................................................................................................................................. 24
Netherlands – Healthcare Inspectorate: Breast implants PIP...............................................................................................24 Singapore – Health Sciences Authority: Regulatory controls for medical devices used in clinical trials in Singapore ...................24 Ukraine – State administration of Ukraine on medicinal products: In Ukraine mostly authorized medical devices are produced in
Germany .....................................................................................................................................................................24 International – International Medical Device Regulators Forum (IMDRF): Five work items agreed for international progression...25
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International Medical Devices Regulatory NEWS-IN-BRIEF
April 15, 2012
Brazil – LNE/G-MED America: Medical Devices Approval Process
LNE/G-MED, a Notified Body on medical devices has written a detailed guide to the Brazilian medical device registration and marketing process. The Guide covers allthe major medical device regulations in Brazil and outlines the process that manufacturers take to register and market their device.
“Get your FREE Guide” http://www.lne-america.com/quality-news-faqs/free-guide-brazil-md-approval.html
International ISO: ISO standards updates and medical devices
Supplement to ISO Focus –April 2012 This supplement contains information about ISO medical devices Standards “in process”: “Quality management and corresponding general aspects for medical
devices”, “Anaesthetic and respiratory equipment”, “Prefilled syringes”, “Needle-based injection systems for medical use”, “Medical products containing viablehuman cells”, “Sterilization of health care products”, “Medical devices — Hierarchical coding structure for adverse events” […]
http://www.iso.org/iso/isoupdate_april2012.pdf
April 14, 2012
Europe / European Commission: A new version of the Borderline manual
Manual on borderline and classification in the community regulatory framework for medical devices – Version 1.12 (04-2012) The European Commission issues new version of the Borderline manualNew: “Air purifiers / Air decontamination units / Mobile air decontamination Units”, “Wigs and
head scarves” http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf
April 13, 2012
Australia – Therapeutic goods administration (TGA): PIP breast implants – information update
PIP breast implants – TGA update Updated information on safety concerns with PIP breast implants: 250 Confirmed ruptures and 38 Unconfirmed ruptures http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120413.htm
Korea – KFDA: Regulations and adverse event reporting
Regulations and medical device adverse event reporting (safety information, adverse event evaluation criteria and evaluation methods…) (InKorean)
http://www.kfda.go.kr/search/search.kfda?mid=283&mscode=CA02&cdcode=8,9,15,16&uid=3
http://www.kfda.go.kr/index.kfda?mid=95&seq=3902&cmd=v
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April 12, 2012
China – Clinical trial: OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions
OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions (OPOV) – This study is ongoing, but not recruiting participants. Purpose: OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is
waterproof and a bacterial barrier and is coated with a water-based adhesive. The comparator is a standard care treatment regime comprising tape and gauze. Sponsor: Smith & Nephew Medical (Shanghai) Ltd Location: China http://clinicaltrials.gov/ct2/show/NCT01577225?rcv_d=14&lup_s=03%2F15%2F2012&lup_d=30
April 11, 2012
European Federation of pharmaceutical industries and associations (EFPIA): Industry Perspective on Formulation and PackagingConsiderations – Devices (Integrated Product) Aspects
Industry Perspective on Formulation and Packaging Considerations by Ron Ogilvie (Pfizer) – EFPIA – February 2012 […] Devices (Integrated Product) Aspects: Medical devices (and integrated products – e.g. inhaled products etc.) are designed to be suitable for the user. (1)
This includes risk-based design validation and ‘human factor’ testing (useability engineering) – EN 62366 – Medical device useability engineering – ISO 14371 – Riskmanagement of medical devices. (2) Includes consideration of all potential users – If a geriatric use was perceived this potential use would be designed in or testedfor with representative group of users
http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2012/04/WC500125148.pdf
Europe – Official Journal of the European Union: Harmonised standards, electromagnetic compatibility and medical devices
Official Journal of the European Union 11.4.2012 – Commission communication in the framework of the implementation of Directive 2004/108/EC of 15December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (Text with EEArelevance) – Publication of titles and references of harmonised standards under the directive
EN 55011:2007: Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods ofmeasurement
EN 55011:2009: Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement CISPR 11:2009(Modified)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:104:0038:0058:EN:PDF
Europe – Official Journal of the European Union: Harmonised standards, radio equipment and telecommunications terminalequipment and medical devices
Official Journal of the European Union 11.4.2012 – Commission communication in the framework of the implementation of the Directive 1999/5/ECof the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutualrecognition of their conformity (Text with EEA relevance) (Publication of titles and references of harmonised standards under the directive) (2012/C104/01)
EN 300 674-2-1 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Road Transport and Traffic Telematics (RTTT); Dedicated Short RangeCommunication (DSRC) trans mission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz Industrial, Scientific and Medical (ISM) band; Part 2:Harmonized EN under article 3.2 of the R&TTE Directive; Sub-part 1: Requirements for the Road Side Units (RSU)
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EN 300 674-2-2 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Road Transport and Traffic Telematics (RTTT); Dedicated Short RangeCommunication (DSRC) trans mission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz Industrial, Scientific and Medical (ISM) band; Part 2:Harmonized EN under article 3.2 of the R&TTE Directive; Sub-part 2: Requirements for the On-Board Units (OBU)
EN 301 489-27 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment andservices; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)
EN 301 489-29 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment andservices; Part 29: Specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands
EN 301 489-31 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment andservices; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheraldevices (ULP-AMI-P)
EN 301 839-2 V1.3.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants(ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2of the R&TTE Directive
EN 302 195-2 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra LowPower Active Medical Implants (ULP-AMI) and accessories;Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
EN 302 510-2 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for UltraLow Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
EN 302 537-2 V1.1.2: Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data ServiceSystems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 ofthe R&TTE Directive
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:104:0001:0037:EN:PDF
Europe – European Commission: European Commissioner for Research, Innovation and Science, Ireland, Medtronic and medicaldevices
Opening remarks – Turning of the sod ceremony for the construction of the new Customer Innovation Centre at Medtronic – Máire Geoghegan-Quinn – European Commissioner for Research, Innovation and Science – Galway, 11 April 2012
[…] Medtronic is a global leader in medical technology, employing 36,000 people, with over 2,000 people based in Galway. This new centre is atestament to Medtronic's commitment to working with clinicians, surgeons, researchers and patient groups in the development of new technology so as to improvethe quality of health for patients throughout the world. […] The centre will build on the very strong expertise and proven record that Medtronic has in bringing newinnovative medical devices into the marketplace, and once completed, it will attract the best scientists and researchers from all parts of the world to Galway. Thisnew centre will feature state-of-the-art facilities, including a virtual cath lab, a wet lab and an innovation workshop. […]
Medical technology is a highly significant industrial sector for Europe, most notably in terms of employment, innovation and quality of life. Thereare around 22,500 medical technology companies in Europe, employing approximately 500,000 people. These companies have combined annualsales of 95 billion Euro with, on average, 6 to 8% of this being re-invested in R&D. This strong innovative character is reflected by the fact that more than80% of these MedTech companies are SMEs.
Ireland is a leader in the MedTech sector, employing the highest per capita of medical technology personnel in Europe. Eight of the top twenty globalMedTech companies have a manufacturing base here. Over 40 years experience has resulted in a dynamic, well serviced sector and a globally recognised centre ofexcellence.
The Galway MedTech cluster is an example of a vibrant place for stimulating innovation and promoting entrepreneurial activities in the sector, thanks to multipleinterfaces and the presence of academic and private research centres nearby. Together with the support from the National University of Ireland, Galway, there arenow approximately 40 MedTech SMEs located here. […]
A particular characteristic of the sector is that product development times are significantly shorter than in other fields and the lifecycle for MedTech products is, onaverage, only 18 months. Therefore, Medical Technologies may serve as a model for spurring the innovation cycle and strengthening European competitiveness.
Medical Technologies have great potential for increasing competitiveness, innovation and growth in Europe. The strong presence of SMEs in the sector complementsthe establishment of "Innovation Union", which is one of the EU's central policies for growth and jobs.
Medical technologies also have the potential to play an important role in the new European Innovation Partnership on "Active and Healthy Ageing" that aims toencourage the uptake of research results and deliver new products and healthcare solutions into the marketplace.
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Medical technologies will also be supported under Horizon 2020, our new European programme to boost research and innovation. They will find a place in all threepillars of the programme: under pillar one on developing Scientific Excellence; under pillar two on delivering Industrial Leadership by supporting key enablingtechnologies; and under pillar three on tackling Societal Challenges in the thematic areas of health, demographic change and well-being. […]
http://ec.europa.eu/ireland/press_office/news_of_the_day/word_docs/2012/20120411_speech_galway-medtronic.doc
US – Clinical trials: Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation
Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation. This study is enrolling participants byinvitation only.
Purpose: The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of theirheart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device – VAD) is implanted. Theinvestigators would like to study the mechanism of device and ICD malfunction.
Condition: Heart Failure Sponsor: Virginia Commonwealth University http://clinicaltrials.gov/ct2/show/NCT01576562
April 10, 2012
Europe – European Databank on Medical Devices (EUDAMED): Deadline for data on registration of medical devices manufacturers
Commission decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (notified under document C(2010) 2363) –(2010/227/EU)
Reminder of Article 5: As concerns data existing before the date referred to in Article 6 (1 May 2011), Member States shall ensure that the data on registration ofmanufacturers, authorised representatives and devices are entered into Eudamed in accordance with Article 14a(1)(a) of Directive 93/42/EEC and Article 12(1)(a) ofDirective 98/79/EC. That data shall be entered by 30 April 2012 at the latest.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:EN:PDF
Article 14a(1)(a) of Directive 93/42/EEC: Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competentauthorities to enable them to carry out their tasks relating to this Directive on a wellinformed basis. The databank shall contain the following: (a) data relating toregistration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices […]
Article 12(1)(a) of Directive 98/79/ECArticle 12: Regulatory data in accordance with this Directive shall be stored in a European databank accessible to thecompetent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis. The databank shall contain the following: (a) datarelating to registration of manufacturers and devices in accordance with Article 10 […]
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:EN:PDF
Japan – Clinical trials: Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience/PROMUS
Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience/PROMUS (BEGIN) Purpose: The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link
Xience/PROMUS) in patients with de novo true bifurcation lesions. The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACErate until one year after PCI will be assessed in both groups.
Condition: Coronary Stenosis Intervention: Device: 2-link stent Nobori and 3-link stent Xience/PROMUS Sponsor: Kurashiki Central Hospital Location: Japan http://clinicaltrials.gov/ct2/show/NCT01574586
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Japan – Clinical trials: Multi-center Study for Stent Graft System for Peripheral Artery
Multi-center Study for Stent Graft System for Peripheral Artery – Condition: Symptomatic Peripheral Arterial Disease Intervention: Device: GP1101Sponsor: W.L.Gore & Associates Recruiting – verified April 2012
Purpose: The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral ArterialDisease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass dataderived from a retrospective study.
Condition: Symptomatic Peripheral Arterial Disease Sponsor: W.L.Gore & Associates Locations: Japan http://clinicaltrials.gov/ct2/show/NCT01575808
United-Kingdom – Clinical trials: Functional Outcome in Two Types of Total Knee Replacement Surgery for People WithOsteoarthritis
Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis – This study has been completed Purpose: When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the
Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. And alternative and more recently introduced technique is the 'Mid-vastus approach' inwhich the surgeon will cut through less of the muscle at the front of the leg. In this study we compare the two surgical techniques in a so-called randomized trial.[…]
Sponsor: Queen Margaret University Collaborators: DePuy International – Royal Infirmary of Edinburgh Locations: United Kingdom http://clinicaltrials.gov/ct2/show/NCT01576445
April 10, 2012
Australia – Therapeutic goods administration (TGA): PIP breast implants – TGA update
PIP breast implants – TGA update – april 2012 Number of instances of ruptured PIP breast implants notified to the TGA as of 4 April 2012: 220 confirmed ruptures and 31 unconfirmed ruptures http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120405.htm
Malaysia – Medical Device Control Division (MDCD) of the Ministry of Health: The Medical Device Act 2012 and the Medical DeviceAuthority Act 2012 have been gazetted
MDCD informs that the Medical Device Act 2012 or Act 737 and the Medical Device Authority Act 2012 or Act 738 have been gazetted on 9thFebruary, 2012.
The Acts can be downloaded via the following website; http://www.federalgazette.agc.gov.my/eng_main/main_akta.php?jenis_akta=Baru. http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id=38&Itemid=95
Further information
Act 737 will come into effect later this year and undergoes a transition period before it is fully enforced in two years’ time (2014). The Act specifies requirements formedical device product registration, establishment licensing and conformity assessment body (CAB) registration. Whereas Act 738 details out the organisation of aregulatory body that will implementing Act 737.
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Currently, [MDCD is] undergoing drafting of its Subsidiary Legislations and Guidelines. Once the effective date is announced, medical devices are required to beregistered and establishments will be licensed. All conformity assessment bodies will also be registered during the transition period.
The MDCD would like to inform that it has not given out any appointment to any person or company on its behalf to conduct quality management system (QMS)audit based on ISO 13485 or Good Distribution Practice for Medical Device (GDP MD). You are advised to refrain from entering any contractual agreement whenapproach by such person or organisation. Announcements will be made from time to time with regards to the status of the Act and its Subsidiary Legislations.
http://www.federalgazette.agc.gov.my/outputaktap/20120209_738_BI_JW001759%20Act%20738(BI).pdf http://www.federalgazette.agc.gov.my/outputaktap/20120209_737_BI_JW001759%20Act%20737%20(BI).pdf
April 9, 2012
China – Clinical trials: Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union
Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union – This study has been completed. Purpose: The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union
and shortened period of treatment. Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Locations: China, Jiangsu Province http://clinicaltrials.gov/ct2/show/NCT01574833
April 4, 2012
United-Kingdom – MHRA: Weekly list of Field Safety Notices
United-Kingdom – MHRA: Weekly list of Field Safety Notices 2 – 6 April 2012
Baxter Healthcare: Dialysis, peritoneal tubing set. UV HomeChoice Automated PD set with cassette 4-prong, HomeChoice automated PD set with cassette 4-prongand 8-prong, 5-prong manifold set with System II connectors.
DePuy Orthopaedics: Spinal implants; pedicle screw. Fenestrated screw open alignment guide. DePuy Orthopaedics: Surgical instruments, implant knee prosthesis impactor. Attune impaction handle (254401010). Edwards Lifesciences: Implants, non active, cardiovascular heart valves; percutaneous transcatheter delivery system. Edwards Lifesciences Ascendra2 Transapical
Delivery System, Model numbers: 9350AS23 & 9350AS26, Lot numbers: 59191159 & 59191164. Ethicon Endo-Surgery: Surgical instruments, non articulated cutting blade. Blade - Harmonic® hand piece Harmonic® Blue hand piece and Blue test tip. Greiner Bio-One: Surgical instruments, miscellaneous, blood sample collection equipment. Vacuette Quickshield Complete Plus. IDEV Technologies: Implants, non active, peripheral vascular stents. Super Veritas self-expanding Nitinol stent peripheral vascular & biliary system. Stryker Medical: Beds and accessories; bed. Stryker Medical Epic critical care beds, Epic Zoom critical care beds and Secure II beds - Models 2030, 2040, 3002
and 220 /230 Volt Bed Models 2031 and 3221. Stryker Orthopaedics: Joint prosthesis, hip prosthesis. Mitch TRH acetabular cup/Mitch TRH modular head when implanted with the uncemented Accolade femoral
stem. Teleflex: Airway devices; guedel airways. Hudson RCI BiteGard oral bite block. Rocket Medical: Chest drains and accessories underwater chest drainage bottle. R54546. Woodway: Therapy, standing & walking tread mill. All PPS series models (PPS ortho, PPS med and PPS plus) equipped with a motor controller type "Quantum"
B3215 Firmware Rev. "F". http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON149596
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April 4, 2012
Europe – Notified Bodies: LGA InterCert Medical and TÜV Rheinland LGA Products become one
The medical divisions of the TÜV Rheinland companies LGA InterCert and TÜV Rheinland LGA Products will join forces. Thus, LGA InterCert’s NotifiedBody for medical devices will be integrated into the Notified Body TÜV Rheinland LGA Products GmbH. As a consequence the testing, auditing and certification ofmedical devices will in the future be carried out by one single Notified Body. This consolidation will result in one of the largest Notified Bodies for medical devices,which is able to offer its customers security and continuity, due to the size and international orientation of the company. This is particularly relevant in times ofstructural changes in the EU’s medical device legislation and the call for higher requirements.[…]
http://www.tuv.com/news/en/corporate/about_us_1/press/news_2/newscontent_cw_95333.jsp/LGA%20InterCert%20Medical%20and%20T%C3%9CV%20Rheinland%20LGA%20Products%20become%20one
April 3, 2012
Brazil – Ministry of Health: National health products and preference in federal procurement
COMPLEXO INDUSTRIAL – Produtos nacionais terão preferência em compras (in Portuguese) Domestic products shall have preference in purchasing: More than 120 health products produced in the country will have preference in federal
procurement. Measure will stimulate investment and innovation in Brazil, and reduce dependence on imports […] investments and partnerships: The Ministry ofHealth is developing several initiatives to strengthen the domestic industry, and stimulate productive development and innovation. […] These agreements cover themanufacture of biological products (for rheumatoid arthritis, genetic diseases and cancer), medicines for so-called "neglected diseases" and equipment, especially inthe field of orthotics and prosthetics. […] The savings generated by these partnerships is $ 400 million a year on procurement.
http://portalsaude.saude.gov.br/portalsaude/noticia/4697/162/produtos-nacionais-terao-preferencia-em-compras.html
Australia – Therapeutic goods administration (TGA): Brochure for health professionals about reporting medical device adverseincidents
Reporting medical device adverse incidents – Brochure for health professionals about reporting medical device adverse incidents Introduction: The TGA's Office of Product Review developed the brochure below to encourage health professionals to report adverse events or incidents related to
the use of medical devices. Health professionals have expert knowledge related to device use and safety and are likely to observe adverse incidents associated withthe use of medical devices. Reports of adverse events submitted by health professionals contribute to the ongoing collection of information that occurs once medicaldevices are on the market.
Content: “Who can report on an adverse event?”, “Your role in reporting an adverse event”, “What should you include?”, “What happens to the report at the TGA?”,“How you can report”
http://www.tga.gov.au/hp/problem-device-reporting-incidents.htm http://www.tga.gov.au/pdf/hp-problem-device-reporting-incidents.pdf (november 2011)
April 2, 2012
Spain – Spanish Agency for Medicines and Healthcare Products: increasing activated for medical devices
Lunes, 2 de abril de 2012 – La Agencia Española de Medicamentos y Productos Sanitarios incrementa su actividad en todas sus áreas – The SpanishAgency for Medicines and Healthcare Products increased its activity in all areas
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Medical Devices: In the field of medical devices, the Competent Authority, acting as a Notified Body, granted the CE conformity marking to 213 products (486variants) and extended the CE [Mark] to 121 products (337 variants), making 119 quality audits of manufacturers. As for the performances of surveillance devices,the Competent Authority receives reports of adverse events and safety corrective action by manufacturers, managing the Monitoring System Devices andtransmitting alerts to the regions. This activity showed a significant increase over previous years, with 2,378 notifications received during the years 2011 and 638alerts transmitted (16% on the year 2010). He also recorded a significant increase in the activity of market surveillance to detect non-compliant medical devices andillegal.
http://www.lamoncloa.gob.es/ServiciosdePrensa/NotasPrensa/MinisterioSanidadServiciosSocialesIgualdad/2012/020412-medicamentos.htm
For further information
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) – Memoria de actividades 2011d A chapter of the AEMPS Activities Report 2011 deals with medical devices http://www.aemps.gob.es/laAEMPS/memoria/docs/memoria-2011.pdf
Australia – Therapeutic goods administration (TGA): PIP breast implants – Progress review of on-going TGA Laboratory testingprogram
PIP breast implants – TGA update – This TGA update discusses on “Progress review of on-going TGA Laboratory testing program” URL: http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120402.htm
Some excerpts
PIP breast implants: AFSSAPS has reported that there are at least three different formulations of filler gel used in PIP breast implants. The different formulas aredetailed in the table below. According to AFSSAPS, the authorised gel was manufactured with NUSIL 3MED6300 gel, while the unauthorised gels were manufacturedusing a combination of other brands of silicone raw materials, with two different formulations identified as PIP1 and PIP2. Apparently, PIP1 was manufactured priorto 2008 and PIP2 from the beginning of 2008. It is not clear when NUSIL was used to manufacture the gel used in PIP breast implants, but it appears that this gelwas used in micro-textured PIP breast implants after the middle of 2006, although this type of implant does not appear to have been supplied in Australia.
NUSIL PIP 1 PIP 2
Manufacturer of rawmaterials
NusilBluestar – Rhodorsil productMomentive – Silopi product
Bluestar – Rhodorsil productMomentive – Silopi product
Silicone oil trimethylated Silopi (W1000)or Rhodorsil (H47V1000)
94.3%Silicone oil trimethylatedSilopi (W1000) orRhodorsil (H47V1000)
90.2%
Vinyl terminated silicone oil Silopi (U165) 4.4%Vinyl terminated siliconeoil Silopi U165
8.3%
Rhodorsil RTV 141 Part A 1.1% Rhodorsil RTV 141 Part A 1.1%
Rhodorsil RTV 141 Part B 0.2% Rhodorsil RTV 141 Part B 0.4%
Formula
NUSIL 3MED6300
100%
Ratio of Rhodorsil RTV A:B = 5.5 compared to manufacturer'srecommendation of 10
Ratio of Rhodorsil RTV A:B = 2.75 compared tomanufacturer's recommendation of 10
TGA Laboratory testing plan –Range and number of samples: The TGA testing program has used samples from the broadest cross-section of batches andmodels of PIP breast implants available to the TGA, and has also tested batches of other brands of breast implant for comparison.The TGA is also testing differentsilicone raw materials that have been used in the manufacture of the silicone gel in the PIP breast implants. To date, TGA has received 19 different batches (29samples), from the Australian market, and 5 batches (23 samples), from overseas, of PIP breast implants. Findings from testing these batches build on the testingof around 30 batches by AFSSAPS and the results reported by the MHRA.By way of example, AFSSAPS used 5 batches in an 'elongation test' and 4 batches in an'intradermal irritation test'. The TGA further investigated those tests by testing 13 batches in the elongation test and 7 batches in the intradermal irritation test (instudies TGA commissioned both in Australia and in Europe). To date, the TGA has also conducted tests on 14 PIP breast implants that have been surgically removed(explanted) to provide further evidence that will assist with determining the overall quality and safety of the product. The TGA is not aware of any regulator fromany other country that has reported results from testing explanted PIP breast implants.
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TGA Laboratory testing plan –Testing regime: Since the original advice was that PIP breast implants had been manufactured with unauthorised silicone gelfiller, initial testing focussed on establishing the physical and mechanical properties, as well as the toxicity of the implants. Subsequent reports, particularly inFebruary and March 2012, presented clearer details of the findings from laboratory testing commissioned by AFSSAPS. Consequently, TGA focussed its laboratoryinvestigations on: “the irritant potential of the shell and gel used in PIP breast implants”, “chemical toxicity, including presence of metals”, “mechanicalcharacteristics of the shell, with special regard to the tensile elongation test”, “mechanical characteristics of the filler gel, with special regard to the firmness andcohesiveness of the gel”, “chemical analysis of the gel, especially determining the presence of low molecular weight silicones”, “other physico-chemical features ofthe gels, especially thermogravimetric behaviour”, “investigation of explanted PIP breast implants”. […]
Study Test
Toxicology Intra-dermal irritation – ISO 10993-10: 2010 Cytotoxicity – ISO 10993-5:2009
Chemical analysis
Chemically fingerprinting using Fourier transform infrared spectroscopy (FTIR) Chemically profiling using gas chromatography-mass spectrometry (GC-MS), thermogravimetric analysis (TGA) and gel
permeation chromatography (GPC). Presence and quantification of D4-D6 siloxanes using headspace and direct injection GCMS. Presence of metals using inductively coupled plasma mass spectrometry (ICP-MS)
Physico-mechanical tests
Tensile Elongation – ISO 14607:2007 Annex B Section 1.2 Tensile Set – ISO 14607:2007 Annex B Section 1.3 Strength of joints, seams and seals – ISO 14607:2007 Annex B Section 2 Silicone Gel Cohesion – ISO 14607:2007 Annex D Section 4&5
Testing on explanted PIPimplants
Visual examination with photography and microscopy, as well as chemical and mechanical analysis as appropriate.
Findings from testing –Summary: (1) While AFSSAPS reported a 'potential irritant' finding for the filler silicone gel, this is not consistent withtesting results from studies commissioned by the TGA. Two different laboratories (in Australia and Europe) carried out tests in accordance with theinternational standard and results from both laboratories indicated that the gel and the shell of tested PIP breast implants were non-irritant. (2) Testing by the TGA,MHRA and AFSSAPS has not shown chemical toxicity to living cells (cytotoxicity). Furthermore, testing by AFSSAPS and MHRA has not shown toxicity to DNAwithin the genetic machinery of the cell (genotoxicity). (3) Consistent with reports by AFSSAPS, the TGA has noted that there is variability in the physico-chemical characteristics of different batches of PIP breast implants. (4) Questions have been raised about the amount of small molecular weightsilicones (D4-D6 siloxanes) that may be present in unauthorised gels. To date, chemical testing indicates that the amount of these siloxanes in PIP breastimplants is not a safety concern. (5) Testing has not identified any metals in the tested PIP breast implants that are at a level of concern. (6) The TGAtesting did not identify problems regarding shell integrity, although AFSSAPS reported failures related to the tensile elongation test. (7) While TGAinvestigations generally found filler gels to be suitably firm and cohesive, some PIP breast implants appear to be less firm. […]
URL: http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120402.htm
United-Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA): New advice to surgeons about metal-on-metaltotal hip replacements
Press release -MHRA issues new advice to surgeons about metal-on-metal total hip replacements – Date:2 April 2012 Text: The Medicines and Healthcare products Regulatory Agency (MHRA) today issued advice to surgeons to stop using a particular combination of metal-on-metal
total hip replacements because it has a high revision rate compared with other implants. The MHRA has also advised surgeons to closely monitor patients with thiscombination of implants. The advice is included in a new MHRA Medical Device Alert that has been issued to clinicians today for the management of patients theMitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics. Surgeons are being advisedto stop using this combination of hip replacements because information from the England and Wales National Joint Registry (NJR) shows that it has an unacceptablyhigh revision rate of 10.7 percent after four years of implantation. The MHRA is advising surgeons to follow up with patients with this combination of devices as wepreviously advised in February 2012. The MITCH TRH hip is a metal-on-metal hip replacement system consisting of components which can be used in differentcombinations to carry out either hip resurfacing arthroplasty or total hip replacement. Patients with the MITCH TRH resurfacing implants are not affected by thislatest notification. There are around 270 people with this combination in England and Wales according to the NJR. Dr Susanne Ludgate, Clinical Director of the
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MHRA, said: “The majority of patients implanted with metal-on-metal hip replacements have well functioning hips and are at a low risk of developing any seriousproblems. Patients with metal-on-metal hip replacements should already be regularly monitored by their clinician. “Analysis has shown that the revision rate for thiscombination of implant is unacceptably high. This is why we have advised surgeons to stop using this combination and to monitor their patients closely. “We havepreviously taken prompt action in February to investigate safety concerns and provided advice on patient management to relevant healthcare professionals."
http://www.mhra.gov.uk/PrintPreview/PressReleaseSP/CON149601
For further information
Medical Device Alert: Metal-on-metal (MoM) total hip replacements (MDA/2012/016) http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON149600 http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con149604.pdf
Canada – Health Canada: Medical Device Recall Listings Date April 2012 – June 2012
Medical Device Recall Listings – Sorted by Recall Posting Date April 2012 – June 2012 Manufacturer –4 april 2012: Coloplast A/S, Abbott Point of Care Inc., Alere San Diego, Inc., Animas Corporation, Baxter Healthcare Corporation Renal Division,
Becton Dickinson and Company, Brainlab AG, Carl Zeiss Meditec AG, Codman and Shurtleff Inc., GE Hangwei Medical Systems Co. Ltd., GE Healthcare Finland OY,Immucor Inc., Oxoid Company, Sorin Group Deutschland GMBH, Stryker Orthopeadics, Supersonic Imagine, Terumo Cardiovascular Systems Corp., ThoratecCorporation, Vascutek Ltd., ,
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.php http://www.hc-sc.gc.ca/dhp-mps/alt_formats/xls/compli-conform/recall-retrait/list/md-im_recalls-retrait_apr-june_2012-eng.xls
Canada – Health Canada: Revisions made to guidance documents and forms for medical devices –fees
“Drugs and Health Products – What's New”
Revisions made to guidance documents and forms for drugs and medical devices to show the annual 2% increase in fees as per the Fees in Respectof Drugs and Medical Devices Regulations as well as other minor revisions to improve clarity of the Guidance Document – Fees for the Review ofDrug Submissions and Applications.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/cr_notice_rc_avis-eng.php
Guidance Document – Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices [2012-04-02] http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_licren_mm_homren-eng.php Fees for the Review of Medical Device Licence Applications [2012-04-02] http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/guidedoc_feesmd_docorient_fraisim-eng.php Class IV Medical Device Licence Amendment Application Form – Address Update [2012-04-02] http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php Class III Medical Device Licence Amendment Application Form – Address Update [2012-04-02] http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php Application For a New Class IV Medical Device Licence – Update [2012-04-02] http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php Application For a New Class III Medical Device Licence – Update [2012-04-02] http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla3-eng.php Application For a New Class II Medical Device Licence – Updated [2012-04-02] http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php
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March 30, 2012
Australia – Medical technology association of australia (MTAA): Medical technology industry a key to economic growth in Australia
2012 Media Releases – Medical technology industry a key to economic growth in Australia – 30 March 2012 Text: The medical technology industry is a highly innovative sector with the capability to create highskilled manufacturing jobs and to harness Australia’s strengths
in health and medical research according to a white paper released by the Medical Technology Association of Australia (MTAA). The medical technology industry islargely overshadowed in the current debate about the contribution of the advanced manufacturing sector to Australia’s economic future but provides some leadingexamples of successful Australian manufacturing. “Australia has many of the right attributes to grow a strong domestic industry – a significant health and medicalresearch capability, quality health system, highly skilled manufacturing workforce, stable financial system, and access to the growing middle class markets of Asia,”said Anne Trimmer, MTAA Chief Executive Officer. The medical technology industry has grown steadily in recent years to record revenue of $8.02 billionin 2010-11. However Australia suffers a net deficit in trade with significantly more products imported than exported. In fact the value of exports hasfallen over the past three years. MTAA is calling on the Federal Government to provide policy leadership so that the right levers can be put in place todevelop a sustainable medical technology industry for the long term. Policy strategies that might be employed to grow this sector of the Australian economyinclude better integration between health systems needs and industry innovation and development; emphasis on science, maths and engineering education;encouragement of clusters of industry and research; and pathways to market for innovative technologies, both in Australia and regionally. “Governments in otheradvanced economies have identified the medical technology sector as a growth area ready for policy support. Australia must compete to ensure that its advancedmanufacturing sector retains a skilled workforce which can be used in medical technology manufacturing,” Ms Trimmer said.
http://www.mtaa.org.au/pages/page421.asp
For further information
“The white paper Building a sustainable Australian medical technology industry – March 2012” http://www.mtaa.org.au/pages/images/Building%20a%20sustainable%20Australian%20medical%20technology%20industry%20white%20paper%20final%20March
%202012.pdf Executive summary: […] Australia suffers an imbalance in trade in medical technology with most of the technology used in Australia imported, and nearly all of
the medical technology products manufactured in Australia exported. Australia has excelled in the development of niche products to supply the global market –Resmed’s devices to treat sleep disorders, Cochlear’s electronic hearing device, and Sirtex’s Sirsphere’s cancer treatment device. […] The medical technologyindustry has not had the attention that is needed from policy makers. […] This white paper proposes strategies which give guidance for the development of policiesto ensure a sustainable industry into the future.
Proposals for action:[…] MTAA proposes that a roundtable be established to undertake an audit of Australia’s capabilities and preparedness to develop a medicaltechnology sector, to identify the gaps that would work against the development, and identify solutions to bridge those gaps.[…]
Profile of the medical technology industry in Australia: […] Total revenue for the Australian medical technology industry in 2010-11 is calculated by MTAA at$8.02 billion. […] Of the medical technology companies operating in Australia, approximately 23% are manufacturers, 21% are subsidiaries of multinationalcompanies, and the remainder are independent distributors. […]
An innovative industry and emerging trends: […] Five new pillars of innovation will be required for the medical technology ecosystem in 2020: “System-oriented and value-based incentives (with a focus on the development of whole-care, patient-centred solutions)”, “Global networks of academic medical centres(noting the increasing investment by emerging nations in research and development)”, “Competing regulatory systems (companies will move into markets wherethey can obtain approvals more quickly, generate returns faster and engage patients and providers in the cycle of innovation)”, “Individualized solutions and price-sensitive customers (providers will look to companies worldwide for technology solutions that offer more integrated, holistic, cost-effective devices combined withwellness and disease management services)”, “Global financial networks (funding will follow the shift of investment opportunities to new markets)” […]
Need for policy levers: […] MTAA argues that as a nation we need to shift our focus to growth sectors such as the medical technology industry by providingincentives for companies to invest in additional research and development and local manufacturing much in the way that John Button’s plans for the pharmaceuticalindustry were structured in the 1980s when he was the Minister for Industry.[…]
What other countries are doing: Information on Singapore, South Korea, Ireland, Denmark and Israel Deriving benefit from Australia’s proximity to Asia: […] There is an opportunity for innovative Australian companies to respond to the need of many Asian
countries for more frugal technology which is suitable for low resource settings. […] Building the manufacturing base: Information on Southeast Michigan Council of Governments and the Metropolitan UK and Australia
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Securing a skilled workforce: […] Where Australian companies are not able to recruit sufficient numbers of skilled workers locally, the retention of schemes suchas the living away from home allowance assists in ensuring that appropriately skilled workers are attracted to Australia as a place to work, and their employerssupported […]
Development of industry clusters: […] The medical technology sector would benefit from the nurturing of clusters which provide a well-established pathway forindustry development in other countries. […] Information on Denmark, Sweden, Switzerland, Singapore, Korea, India and China
Supporting emerging companies: […] there is a need to support the development of prototype products at the critical early commercialisation stage […] Areas ofassistance should be designed to ensure companies are well versed in regulatory affairs, quality management, and reimbursement and that they have access toclinical investigations and access to local manufacturing. Information on US and Canada
Regulatory alignment: […] The regulation of medical technology in Australia must remain aligned with major competitor economies. […] The number of clinicaltrials of medical technologies in Australia has also increased exponentially from around 10 in 2001 to around 340 in 2010 […] )
Integration with health policy: […] T here are excellent examples in comparable economies where health policy makers work with the medical technologyindustry and industry policy makers to put in place levers which support development of a sustainable industry.[…] governments in the United Kingdom over thepast decade have instituted a range of policies to support the life sciences industry in that country […] In Canada, the Ontario Government announced theestablishment in December 2011 of the MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE). […]
http://www.mtaa.org.au/pages/images/Building%20a%20sustainable%20Australian%20medical%20technology%20industry%20white%20paper%20final%20March%202012.pdf
Australia – Therapeutic goods administration (TGA): PIP breast implants – Information update
30 March 2012 – PIP breast implants – TGA update – Updated information on safety concerns with PIP breast implants Text: […] Testing undertaken by TGA to date has not found evidence that the risks involved with the use of PIP breast implants are any greater than those for any
other brand of silicone gel-filled breast implants. […] The Australian Government's advice remains that removal of PIP breast implants in the absence of evidence ofrupture is not routinely required. […]
Reports of problems with PIP breast implants. The table below shows the number of instances of ruptured PIP breast implants notified to the TGA as of 29 March2012.
Reporter Confirmedi ruptures Unconfirmed ruptures
surgeons 131 24
patients 54 7
supplier 24 0
All reporters 209 31 The TGA categorises ruptures as 'confirmed' if there is sufficient information to uniquely identify: (a)the patient, (b)the implant used, (c) that an X-Ray or other
diagnostic image showed that the device was ruptured; or the implant was found to be ruptured when it was removed. The TGA has sought further information butas yet has not received sufficient information to uniquely identify the rupture.
http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120330.htm
US – Food and Drug Administration (FDA): The safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems
Food and Drug Administration – Docket No. FDA-2012-N-0293 – Orthopaedic and Rehabilitation Devices Panel of the Medical – Devices AdvisoryCommittee; Meeting
Summary: Announcement of a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA) to discuss current knowledge aboutthe safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on therisks and benefits of these types of devices based on available scientific data. The meeting will be open to the public. The meeting will be held on June 27 and 28,2012, from 8 a.m. to 7 p.m. […]
http://www.gpo.gov/fdsys/pkg/FR-2012-03-30/html/2012-7767.htm
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Supplementary information
Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidenceof sufficient sound bone to seat and support the components. There are two categories of metal-on-metal hip arthroplasty systems: 1. Metal-on-Metal total hipreplacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone(acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions: a.Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painfulhip dysplasia; b. Inflammatory degenerative joint disease such as rheumatoid arthritis; c. Correction of functional deformity; and, d. Revision procedures whereother treatments or devices have failed. 2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering anda metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function inskeletally mature patients having the following conditions: a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis,or dysplasia/developmental dislocation of the hip (DDH); or b. Inflammatory arthritis such as rheumatoid arthritis.
Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hiparthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
In February 2011, FDA published a Web site on MoM total and resurfacing hip systems with information for orthopedic surgeons and for patients with or consideringhip replacement
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm).
Numerous recent publications, studies and registry reports have raised safety concerns for MoM THRs. In February 2012, the United Kingdom's (UK)Medicines and Healthcare products Regulatory Agency (MHRA) published a Medical Device Alert with updated advice on the management and monitoring of patientsimplanted with MoM hip systems recommending more aggressive followup of patients with larger THR systems (>=36 millimeter (mm)).
Further information about actions taken by MHRA, with links to information about MoM hip implants for patients and healthcare professionals, is available on theirWeb site at
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Metal-on-metalhipimplants/index.htm.
In December 2011, the American Academy of Orthopedic Surgeons (AAOS) published an overview on MoM hip systems (total and resurfacing)(Ref.1). The AAOS overview provides a summary of clinical outcomes in patients with MoM hip systems in comparison to other bearing surface combinations, addressespatient, implant and surgical factors that may predict successful/unsuccessful outcomes of MoM hip systems and discusses the prevalence of adverse clinicalproblems from MoM hip systems in comparison to other bearing surface combinations. One item referenced in the report is the Australian registry, which reportedhigher revision rates for patients with implants that have large- diameter heads (>=28 mm).
http://www.aaos.org/research/overviews/Metal_On_Metal.pdf.
While current data are highly suggestive that a large percentage of patients with MoM hip systems have successful outcomes, a recent scientificpublication raised serious concerns about the failure rates of MoM hip systems for the UK population (Ref. 3). This peer-reviewed journal articlepresented the following findings regarding primary MoM THR: (1) Increased failure rate at 5 years for MoM THR related to larger head sizes; (2) significantly higherrisk for revision in female patients (Note: In the United States, labeling discourages use of MoM hips in females of child bearing age with warnings in MoM THRlabeling and contraindications in MoM hip resurfacing labeling); and (3) revisions for dislocation in men with MoM replacements were slightly lower, showing somebenefit to larger head sizes.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736 (Ref.3) (broken link after publishing)
The committee will be asked to discuss the following as it pertains to these devices in the U.S. population: Device mechanisms of failure, metal iontesting, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical followup considerations forpatients with MoM hip systems (total and resurfacing)[…]
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Japan – Ministry of health: Regenerative products and medical devices
Project – promotion of commercialization of regenerative products -medical devices, pharmaceuticals http://www.mhlw.go.jp/stf/houdou/2r98520000026xxr.html
United-Kingdom – MHRA: Weekly list of Field Safety Notices 26 – 30 March 2012
Weekly list of Field Safety Notices 26 – 30 March 2012 Agfa Healthcare: X-ray, digital acquisition systems; direct digital radiography. DX-D 10G, DX-D 10C, DX-D 20G & DX-D 20C - digital detectors (connected via
cable) for direct digital imaging size 35*43cm. Boston Scientific: Urinary catheters and accessories - urinary tract access catheter. Imager™ II Urology Torque catheters. Boston Scientific: Vascular cannula and catheters; catheter angiography. IMAGER™ II angiographic catheter. Codman & Shurtleff: Implants, active, infusion pumps programmable pump. MEDSTREAM pump. GBUK Healthcare: Suction equipment, suction catheter. TenderTip closed suction - TT02-12-T34-N, TT02-12-E54-N, TT02-14-T34-N, TT02-14-E54-N, TT03-12-
T34-N, TT03-12-E54-N, TT03-14-T34-N, TT03-14-E54-N. Meditech Systems: Breathing system components catheter mount. 22X150S X-tendable catheter mount + elbow. Merck Serono: Injection devices - auto injector. Easypod. Philips Healthcare: Computed tomography system. Brilliance 64 and Ingenuity CT with software version 3.5.1. Philips Medical Systems: X-ray, fluoroscopy systems. MultiDiagnost Eleva FD. Welch Allyn: Monitors, patient; multi parameter monitor. VSM 200 & 300 series, SPOT vital signs and SPOT LXi. Wescott Medical: Urinary catheters and accessories - irrigation set. WEFLOW3.
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON146834
March 29, 2012
International – International Organisation for Standardisation: An ISO/IEC guide upgrades safety aspects in medical devicestandards
Geneva, Switzerland, 2012-02-29 – IEC and ISO have just published a new, improved guide to help standards writers address safety aspects inmedical device standards even more thoroughly.
ISO/IEC Guide 63, Guide to the development and inclusion of safety aspects in International Standards for medical devices, improves on andreplaces a 1999 edition.
A global approach among manufacturers, users, regulatory authorities and other stakeholders is needed for the planning and development of medical device safetystandards. To create a coherent approach to the treatment of safety in the preparation of standards, close coordination within and among committees responsiblefor different medical devices is necessary.
ISO/IEC Guide 63 is designed to improve the interface between the standards-developing committees and the stakeholders they serve, as well as to make optimaluse of resources by only developing medical device safety standards for which there is a clear market requirement.
The guide is intended to be used by all ISO and IEC bodies involved in the development of medical device safety standards. It can also be used by non-ISO and IECstandards development organizations at the international, regional or national levels that are considering or are in the process of developing medical device safetystandards and/or comparable documents.
http://www.iec.ch/newslog/2012/nr0212.htm
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Ireland parliament: PIP breast implants and the the revision of the medical devices legislation
Irish medicines board – oireachtas committee on health –poly implant prothèse (pip) breast implants […] The revision of the medical devices legislation: The three primary European Directives relating to medical devices are being substantially revised by the
European Commission and it is expected that they will adopt two new Regulations relating to medical devices before the end of July 2012. These will then be subjectto debate at the European Council and Parliament. In early February 2012, Commissioner Dalli (Health & Consumers) has written to each of the national Ministersfor Health across Europe indicating the need to increase control on medical devices to provide an appropriate level of protection to European citizen and restore trustand confidence in the regulatory system for devices. Commissioner Dalli recognised that legislative revision would take several years to come into effect andidentified the need to act immediately to achieve these objectives.
Closing remarks: The IMB fully appreciates the anxiety and concern this issue has caused the 1,550 women affected in Ireland. We have been speakingindividually with many women who have contacted us and have met with a group of representatives. We are ensuring that they have all the available information onthis issue and are assisting them with their individual concerns. We have also been invited to attend meetings arranged by the Department of Health and the ChiefMedical Officer with some of the cosmetic clinics and have added our voice to urging the clinics to have a duty of care to all their patients and to ensuring that allpatients receive appropriate review. The advice of the IMB, based on the evidence available from the ongoing investigation, remains unchanged: there is no currentevidence of particular health risks associated with PIP silicone breast implants. The IMB continues to advise women with these implants, that if they have anyconcerns about their breasts or implants, they should seek clinical advice from their implanting surgeon. The best interests of the affected women is our primaryconcern and we are monitoring the situation rigorously and liaising closely with our European and international regulatory colleagues to ensure that any newinformation that may emerge is assessed swiftly and that we continue to provide expert advice to the patients and indeed the cosmetic clinics involved.
http://www.oireachtas.ie/parliament/media/committees/healthandchildren/J39_OpeningStatement_FINAL.pdf
United Kingdom – Health and Safety Executive (HSE) / Medicines and Healthcare Products Regulatory Agency (MHRA):Arrangements for liaison between the HSE and the MHRA, Medical Devices Division
Arrangements for liaison between the Health and Safety Executive (HSE) and the Medicines and Healthcare Products Regulatory Agency (MHRA),Medical Devices Division
http://www.hse.gov.uk/aboutus/howwework/framework/mhra-working-arrangements-agreement.doc
Reminder:
The MHRA is an executive agency of the Department of Health with responsibility for ensuring that medicines and medical devices are effective and acceptably safe. The HSE is responsible for the enforcement of the Health and Safety at Work etc Act 1974 throughout Great Britain. Its work includes ensuring that ‘risks to people’s
health and safety from work activities are properly controlled’.
Supplementary information about arrangements for liaison between the HSE and the MHRA
Foreword: The aim of this agreement is to describe and promote effective working arrangements between the Health and Safety Executive (HSE) and the MedicalDevices Division of the Medicines and Healthcare products Regulatory Agency (MHRA). This agreement does not cover the Medicines Division of the MHRA. Goodworking relationships are particularly important with investigation and enforcement activity - to enable serious incidents to be investigated efficiently and with pace.We are making progress in this regard, with the MHRA recently becoming a signatory to the Work Related Deaths Protocol (WRDP) for England and Wales.Discussions are currently taking place with the MHRA on signing up to the Scottish WRDP. The HSE and the MHRA have a clear common interest in patient safety.This agreement sets out the commitment of the two organisations to work together effectively on matters concerning medical devices. In particular: co-operating onnon-fatal accident investigations; investigating fatal accidents in accordance with the two WRDPs; sharing information; and raising awareness. This agreement is aliving document and will be reviewed on a regular basis.
Excerpts: […] The HSE will inform the MHRA, as soon as practicable, when it becomes clear that information, or emerging evidence from an incident or a complaint,is relevant to the MHRA. This includes significant dangerous occurrences such as ones that might have resulted in major injury or death. […] MHRA staff will informHSE as soon as practicable if they are notified of an incident involving the use of a medical device in relation to a work activity which has led to major injury ordeath. HSE and MHRA staff are aware of relevant contact details. […]
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Europe - Official Journal of the European Union: Regulation on electronic instructions for use of medical devices
Official Journal of the European Union 10.3.2012 COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF
March 28, 2012
United-Kingdom – parliament Health Committee: All providers should offer to replace breast implants which have failed accordingto Health Committee
All providers should offer to replace breast implants which have failed according to Health Committee The Health Committee welcomes the Government's decision to commission two reviews following public concern about breast implant surgery,
following the decision of the French authorities to recommend removal of implants sourced from PIP. The Committee recommends that Earl Howe's review should focus on the following key policy issues: The Committee is concerned about the quality of
information available about devices that have been implanted into patients; the Committee regards the maintenance of a full audit trail of devices implanted intopatients as essential to good medical practice, and recommends that these procedures should apply in all care environments – in both the public and private sector– and that the information should be readily retrievable by a patient's clinicians. The Committee was concerned by evidence that MRHA notices withdrawing CEregistration from individual products do not require any positive response from non-NHS users of those products; it recommends that Earl Howe's Review considerrequiring all relevant care providers to confirm they have received and acted on such notices. The Committee also recommends that such obligations should applyequally to all care providers – both public and private sector. The Committee was concerned by evidence that some patients may have received implants withoutbeing fully aware of the medium and long term consequences of such implantation – in particular including the fact that all implants eventually require replacement.Surgeons working in this field have a professional obligation to ensure that their patients consent to treatment and that such consent is provided on a fully informedbasis. The Committee further recommends that the GMC review surgeons' performance of this obligation, and of the obligation to report adverse incidentsconcerning medical devices to the MHRA.
http://www.parliament.uk/business/committees/committees-a-z/commons-select/health-committee/news/12-03-22-pipreport/
United-Kingdom – Parliament: PIP Breast Implants and regulation of cosmetic interventions
Health Committee – Sixteenth Report –PIP Breast Implants and regulation of cosmetic interventions Contents: […] “Evidence on the risks of PIP implants”, “Actions of the Department of Health and the MHRA”, “Regulatory issues” (“CE Mark”, “Register of implants”,
“Responsibilities of provider organisations and medical professionals”, “Adverse incident reporting”, “Informed consent”, “Insurance”), “Conclusions andrecommendations” […]
Tuesday 7 February 2012: Professor Sir Bruce Keogh KBE, NHS Medical Director, Professor Sir Kent Woods, Chief Executive of the Medicines and Healthcareproducts Regulatory Agency, Dr Anne-Marie Slowther, Associate Professor of Clinical Ethics at Warwick Medical School and Consultant Clinical Ethicist at UniversityHospitals, Coventry and Warwickshire NHS Trust, and Mr Simon Withey, Consultant Plastic Surgeon, Member of the Council of the British Association of AestheticPlastic Surgeons and Member of the Steering Committee looking at Standards in Aesthetic Plastic Surgery.
http://www.publications.parliament.uk/pa/cm201012/cmselect/cmhealth/1816/181602.htm
For further information
PIP Breast Implants and regulation of cosmetic interventions – Health Committee – 4 Regulatory issues
Procedures for the follow-up of the CE mark certification have been shown to be inadequate by what has happened in this case. Sir Bruce's review should examinehow to strengthen the CE mark system—for example by ensuring that certified devices are subject to routine review. There must be a procedure whereby theconcerns of national regulators regarding implants manufactured in another European country can be acted upon and investigated.
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Sir Bruce's review should pursue the creation of a register of implants, to improve reporting of adverse incidents, allow better monitoring of outcomes, and allowswift communication with affected parties in the event of a problem being found. Inclusion on the register should be compulsory.
In the light of these issues, the Committee believes that these events prompt some serious concerns which need to be addressed both by provider organisations andthe medical profession, and by their professional regulators.
http://www.publications.parliament.uk/pa/cm201012/cmselect/cmhealth/1816/181608.htm
US – Food and Drug Administration (FDA): ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
ISO 13485:2003 Voluntary Audit Report Submission Pilot Program Online Video Presentation (with Captioning) – Printable Slide Presentation –Transcript http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#gi
US – Food and Drug Administration (FDA): New FDA guidance on considerations used in device approval, de novo decisions –Clinical data, risks, benefits and patient risk tolerance outlined in process
New FDA guidance on considerations used in device approval, de novo decisions – Clinical data, risks, benefits and patient risk tolerance outlined inprocess
The U.S. Food and Drug Administration published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certainmedical devices are considered during pre-market review.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf
FDA news release
Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medicaldevices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present apotential unreasonable risk of illness or injury. The de novo process is available for low – and moderate – risk devices that have been found not substantiallyequivalent (NSE) to existing devices. When evaluating PMA applications or de novo petitions, the FDA relies upon valid scientific evidence to assess safety andeffectiveness. Both clinical and non-clinical data play a role in FDA’s benefit-risk determinations.
The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such asthe type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability ofalternative treatments, and the value the patient places on treatment.The guidance: outlines the systematic approach FDA device reviewers take whenmaking benefit-risk determinations during the premarket review process provides manufacturers a helpful tool that explains the various principal factors consideredby the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available fornovel, low – to moderate – risk devices describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as thenovelty of the device. “This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency inFDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations,“ said Jeffrey Shuren, M.D., director ofFDA’s Center for Devices and Radiological Health (CDRH).
The FDA will also increase the transparency of the decision-making processes by describing the worksheet analysis in the Summary of Safety and Effectiveness Datafor PMAs and the decision summary review memos for de novo decisions. “In addition to bringing clarity to our decision making for industry, this guidance willprovide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Shuren.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297411.htm
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De NovoClassifications – Table of Contents
The Statutory Standard for Safety and Effectiveness Types of Scientific Evidence
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Benefit-Risk Determinations Factors FDA Considers in Making Benefit-Risk Determinations (Assessment of the Benefits of Devices, Assessment of the Risks of Devices, Additional Factors in the
Assessment of the Probable Benefits and Risks of Devices) Examples of Benefit-Risk Determinations (Hypothetical Examples, Examples Based on Actual FDA Benefit-Risk Determinations) Appendix A . Intersection of this Guidance with ISO 14971 Appendix B. Worksheet for Benefit-Risk Determinations Appendix C. Worksheets for Hypothetical Examples http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf
US – Food and Drug Administration (FDA): General issues related to medical devices intended for obese patients
May 10-11, 2012: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement Agenda: On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide
recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons andsuture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining toclinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially smallamount of weight loss.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm297473.htm
Europe – European Medicines Agency (EMA): “Explanatory note on fees payable to the European Medicines Agency” and“Consultation on ancillary substances including blood derivates incorporated in medical devices”
Explanatory note on fees payable to the European Medicines Agency – Mention of medical devices and fees Following the publication of the Rules for the implementation of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures
as last adopted by the Agency’s Management Board on 22 March 2012, the Agency applies the fees and definitions indicated in this document as of 1 April 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500124904.pdf
1.4. Consultation on ancillary substances including blood derivates incorporated in medical devices – Initial request
Basic fee(Level I)
80 300 EURO For consultation on an ancillary medicinal substance or blood derivative new to the centralised procedure. This fee applies wherethe substance/derivative from the specified manufacturer has not been evaluated by the Agency in connection with a previousmarketing authorisation and/or through a previous successful notified body consultation.
Basic fee(Level II)
60 200 EURO For consultation on a known ancillary blood derivative from a known source. This fee applies where the blood derivative from thespecified manufacturer has been evaluated by the Agency in connection with a previous marketing authorisation and/or through aprevious successful notified body consultation.
Basic fee(Level III)
40 100 EURO For consultation on a known ancillary medicinal substance from a known source. This fee applies where the substance from thespecified manufacturer has been evaluated by the Agency in connection with a previous marketing authorisation and/or through aprevious successful notified body consultation.
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1.4. Consultation on ancillary substances including blood derivates incorporated in medical devices – Follow-up to the initial request
Basic fee 20 100 EURO For consultation on a known ancillary medicinal substance from a known source. This fee applies where the substance from thespecified manufacturer has been evaluated by the Agency in connection with a previous marketing authorisation and/or through aprevious successful notified body consultation. In this case a further consultation is requested by a notified body after a firstconsultation, i.e. when additional data are submitted to the Agency for evaluation in response to a list of deficiencies notified in aninitial Agency report.
Basic fee 40 100 EURO For consultation on an amendment to the documentation on an ancillary medicinal substance or blood derivate already evaluatedby the Agency (The amendments should be classified by analogy to Annex I of Commission Regulation (EC) No 1234/2008).
Basic fee 40 100 EURO For consultation on a major amendment to the documentation on an ancillary medicinal substance or blood derivative alreadyevaluated by the Agency (The amendment should be equivalent to a Type II variation as classified by analogy to CommissionRegulation (EC) No 1234/2008).
Basic fee 6 700 EURO For consultation on a minor amendment to the documentation on an ancillary medicinal substance or blood derivative alreadyevaluated by the Agency. (The amendment should be equivalent to a Type IB variation as classified by analogy to CommissionRegulation (EC) No 1234/2008).
Basic fee 2 900 EURO For consultation on a minor amendment to the documentation on an ancillary medicinal substance or blood derivative alreadyevaluated by the Agency. (The amendment should be equivalent to a Type IA variation as classified by analogy to CommissionRegulation (EC) No 1234/2008).
For more information EMA/MB/13210/2012 – Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500124906.pdf
March 27, 2012
Europe – European Association for Medical Devices of Notified Bodies: European Medical Device Notified Bodies Statement onEuropean Medical Device Regulatory Regime
The European Association for Medical Devices of Notified Bodies - Team-NB-Statment 03/27/2012 - European Medical Device Notified BodiesStatement on European Medical Device Regulatory Regime
Text: The European Association for Medical Devices of Notified Bodies strongly condemn the behaviour of the medical device manufacturer Poly Implant Prothèse(PIP in committing deliberate fraud which led to high and unacceptable safety risks for patients. This case should serve as a stimulant to further improve the systemof conformity assessment and surveillance of manufacturers by Notified Bodies as patient safety, public confidence, and ethical behaviour have always been the toppriority of TEAM-NB members. Team-NB fully supports the European Commission’s plan to implement immediate measures and at the same timestrengthen the European medical devices legislation for the future. Team-NB has a firm belief that the principles enshrined in the current EU conformityassessment of medical devices can deliver an effective and efficient system combining direct Competent Authority market surveillance with elements of pre-markettechnical documentation review and on site surveillance in annual audits by Notified Bodies. Team-NB recognises the need for some areas of improvement in thecurrent European regulatory framework for medical device: harmonization of the supervision of the work of Notified Bodies ; Product Responsible Person;access to Post Market Surveillance data, content clarification of technical file in the legislation; product inspection; hotline (whistle blowing);unannounced visits,... TEAM-NB are in the process of working with the EC Commission to achieve their objectives in the revision of the directives.
http://www.team-nb.org/index.php?option=com_docman&task=doc_download&gid=1505&Itemid=38&lang=en
Argentina – Ministry of health: Free Hearing aids and cochlear implants and promotion of social integration of deaf children
Audífonos e implantes cocleares gratuitos para promover la integración social de los niños sordos Free Hearing aids and cochlear implants to promote social integration of deaf children (In Spanish) http://www.msal.gov.ar/prensa/index.php/noticias/noticias-de-la-semana/439-audifonos-e-implantes-cocleares-gratuitos-para-promover-la-integracion-social-de-
los-ninos-sordos
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Europe – European Association for Medical Devices of Notified Bodies: Statement on European Medical Device Regulatory Regime
Team-NB-Statment – The European Association for Medical Devices of Notified Bodies – European Medical Device Notified Bodies Statement onEuropean Medical Device Regulatory Regime – 03/27/2012
Text: The European Association for Medical Devices of Notified Bodies strongly condemn the behaviour of the medical device manufacturer Poly Implant Prothèse(PIP) in committing deliberate fraud which led to high and unacceptable safety risks for patients. [The PIP case] should serve as a stimulant to furtherimprove the system of conformity assessment and surveillance of manufacturers by Notified Bodies as patient safety, public confidence, and ethicalbehaviour have always been the top priority of TEAM-NB members. Team-NB fully supports the European Commission’s plan to implement immediatemeasures and at the same time strengthen the European medical devices legislation for the future. Team-NB has a firm belief that the principles enshrined in thecurrent EU conformity assessment of medical devices can deliver an effective and efficient system combining direct Competent Authority market surveillance withelements of pre-market technical documentation review and on site surveillance in annual audits by Notified Bodies. Team-NB recognises the need for someareas of improvement in the current European regulatory framework for medical device: harmonization of the supervision of the work of NotifiedBodies ; Product Responsible Person; access to Post Market Surveillance data, content clarification of technical file in the legislation; productinspection; hotline (whistle blowing); unannounced visits. TEAM-NB are in the process of working with the EC Commission to achieve their objectives in therevision of the directives.
http://www.team-nb.org/index.php?option=com_docman&task=doc_download&gid=1505&Itemid=38&lang=en
March 26, 2012
United-Kingdom – Parliament: Regulation of medical implants
Regulation of medical implants – 26 March 2012 The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and
medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health. The European Directive on medical devices will be revised later this year with draft proposals expected to be published by July 2012. The European Commission has
already stated that it will use this opportunity to strengthen existing legislation, particularly provisions relating to market surveillance, vigilance and the functioningof notified bodies. The Committee aims to influence this process.
The Committee plans to examine the regulation of medical implants and invites written submissions from interested parties on any of the issues below by noon onThursday 26 April 2012. The inquiry will not focus on cosmetic implants.
http://www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/inquiries/parliament-2010/regulation-of-medical-implants1/
International – International Criminal Police Organization (INTERPOL): A fact sheet about pharmaceutical crime
Fact sheet connecting police for a safer world – February 2012 Headline: We are seeing a significant increase in the manufacture, trade and distribution of counterfeit, diverted, stolen and illicit medicines and medical devices.
It isimpossible to quantify the extent of the problem, but in some areas of Asia, Africa and Latin America, counterfeit medical products can form around one-third ofthe market. The fight against pharmaceutical crime is crucial in order to protect public health on a global scale. Fake drugs often contain the wrong amount of activeingredient – too little, too much or none at all – posing a major health risk.
http://www.interpol.int/en/Internet/News-and-media/Publications/Fact-sheets/Pharmaceutical-crime http://www.interpol.int/content/download/3902/37957/version/12/file/Factsheets_EN_feb2012_DCO04.pdf (broken link after publishing)
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Argentina – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT): A partnership agreement with ae-commerce leader firm in Latin America to control internet sales of drugs and medical products
Convenio con la empresa Mercado Libre –ANMAT REFUERZA CONTROL SOBRE LA VENTA DE PRODUCTOS POR INTERNET – 26 de marzo de 2012 Text: March 26, 2012 – Agreement with the company Mercado Libre – ANMAT INCREASES CONTROLS ON THE INTERNET SALE OF PRODUCTS […] The regulatory
agency today signed a partnership agreement with Mercado Libre, a leading e-commerce in Latin America, to control internet sales of products of ANAT field ofcompetence. The agreement aims to exchange information on the products covered by ANMAT (drugs, medicinal specialities, medical products, dietarysupplements and cosmetics…) that are offered for sale on the website of Mercado Libre. It also establishes the legal and technical advice by the ANMAT, and mutualcollaboration for the detection of situations that may break the law. Therefore from April, ANMATwill work with Mercado Libre to identify those products notcomplying with the legal system, and prevent its publication in the site or request removal. […]
http://www.anmat.gov.ar/comunicados/mercadolibre-anmat.pdf http://home.mercadolibre.com.ar
March 23, 2012
US – Food and Drug Administration (FDA): Safety and effectiveness of two transcatheter Atrial Septal Defect (ASD) occluders
May 24, 2012: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement Agenda: On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD
Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) Devicewas the first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these devices, more informationhas become available regarding adverse events. These events range from rare life-threatening events to more common events that are perceived to have lesssevere clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion were not seen. The purpose ofdiscussion of these events is: (1) to discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discusswhether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) tocommunicate to patients and physicians what is and is not known about device treatment options.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm297470.htm http://www.gpo.gov/fdsys/pkg/FR-2012-03-28/html/2012-7407.htm notice of the meeting
Norway – Health directorates: New measures for breast reconstruction
Press release , 03/23/2012 – New measures for breast reconstruction The report on breast reconstruction was delivered to the Directorate of Health. The report has been prepared by professionals and key representatives of
the Cancer Society and the Association of Breast Cancer. http://www.regjeringen.no/nn/dep/hod/pressesenter/pressemeldinger/2012/nye-tiltak-for-brystrekonstruksjon.html?id=676251 http://helsedirektoratet.no/Om/nyheter/Sider/rapport-fra-arbeidsgruppe-vedrorende-rekonstruksjon-etter-brystkreft.aspx (report)
United–Kingdom: Weekly list of Field Safety Notices 19 – 23 March 2012
Weekly list of Field Safety Notices 19 – 23 March 2012 Boston Scientific Ltd: Surgical, diathermy bipolar electrosurgery. SOLOIST™ single needle electrode. CareFusion: Infusion & transfusion, administration sets, blood administration set. Alaris® IVAC® 590 series blood set. Depuy Mitek, a Johnson & Johnson Company: Implants, ligaments & tendons prosthetic ligaments. Lupine suture anchors (210704, 210705, 210707, 210708,
210709, 210710, 210711, 210712, 222980 and 222981). Derm Tech / Diagmed Healthcare: Surgical equipment; chromoendoscopy dye. Sterile indigo carmin - J2F/810160/2.
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Ethicon Endo-Surgery: Staples and staple guns endoscopic linear stapler/cutter. ECHELON 60 ENDOPATH stapler - EC60, Long60, SC60. Hospira: Infusion systems; electrically powered infusion pump. GemStar bolus cord, GemStar pump. Meditech Systems: Breathing system components filter. 22835XMMS bacterial / viral HME filter with X-tendable catheter mount + elbow. OptiMed: Vascular cannula and catheters; catheter angiography. AltaFlow measuring catheter, pigtail, 5F (1,67mm) x 110 cm. QRS Diagnostic: ECG leads. Leads - Z-7000-0400. Ranier Technology: Surgical instruments, implant distractor. Cadisc-L Instrumentation - Distractor. Siemens: Magnetic resonance, equipment & accessories MRI system. Magnetom Essenza 1.5T systems. Stryker: Implants, non active, peripheral vascular stent. Wingspan stent system and gateway PTA balloon. Stryker: Surgical instruments, implant rasps. Accolade rasp handle assembly. The Spectranetics Corporation: Therapy, lasers; laser catheter. 12 Fr SLS II laser sheath 500-001. Venner Medical: Endoscopes, rigid laryngoscope. Venner A.P. Advance video laryngoscope difficult airway blade (DAB) part number: 700070. http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON146746
March 22, 2012
China – Sate Food and drugs administration (SFDA): Meeting with European Commissioner for Health and Consumer Policy andDirector General of European Commission DG Health and Consumers
Press release 2012-03-22 – SFDA Commissioner Yin Li and Deputy Commissioner Bian Zhenjia meet with European Commissioner for Health andConsumer Policy and Director General of European Commission DG Health and Consumers
Text: On March 20, 2012, Yin Li, Commissioner of the State Food and Drug Administration (SFDA) and SFDA Deputy Commissioner Bian Zhenjia met with thevisiting John Dalli, European Commissioner for Health and Consumer Policy and Paola Testori Coggi, Director General of Directorate General Health and Consumersof European Commission. Both sides exchanged opinions on topics of common interest about drugs, medical devices and cosmetics.
http://eng.sfda.gov.cn/WS03/CL0757/70095.html
Brazil – Agência Nacional de Vigilância Sanitária (ANVISA) / National Agency of Sanitary Surveillance: International experts andBrazilian monitoring of orthopedic implants
Specialistas internacionais conhecem monitoramento brasileiro de implantes ortopédicos – international experts know Brazilian monitoring oforthopedic implants (In portuguse). Representatives of the health authorities of the United States and Canada are in Porto Alegre, Rio Grande doSul, to meet the monitoring work of orthopedic implants made by Conceição Hospital Group (CHG). The project is the result of a partnership betweenANVISA and GHC in order to reduce the number of adverse events and describe the surgical procedures of the National Health System (SUS) that involve orthopedicimplants.
http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/2012+noticias/especialistas+internacionais+conhecem+monitoramento+brasileiro+de+implantes+ortopedicos
March 22, 2012
Brazil – Agencia Nacional de vigilancia sanitaria (ANVISA): The Agency publishes rules on breast implants
Anvisa publica regulamentação sobre prótese mamária – Anvisa publishes rules on breast implants 21 march 2012 (in Portuguese) It was published in the Official Gazette on Thursday (22/3), the RDC No. 16/2012 Anvisa establishing the minimum identity and quality for breast implants. […] One
of the novelties of the new resolution is certified to be made under the Brazilian System of Conformity Assessment (SBAC). Thus, the prosthesis will experience inlaboratory tests to check items such as material strength, the composition of silicon and biological assays.
http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/2012+noticias/anvisa+publica+regulamentacao+sobre+protese+mamaria
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March 19, 2012
International – World Health Organisation: Effective approaches for strengthening multisectoral action for noncommunicablediseases and medical devices
WHO discussion paper 1 – Version dated 19 March 2012 – Effective approaches for strengthening multisectoral action for noncommunicablediseases (NCDs)
Text: […] Three main objectives have been recognized for any general essential medicines and medical devices programme: (i) equitable access; (ii) assuredquality and safety; (iii) quality use by prescribers and consumers. […] The quality and safety of medicines and medical devices for NCDs is directly linkedto the governance of the health system. National regulatory authorities need to be adequately resourced and staffed and have legal powers to inspect facilitiesand products and to enforce regulations. Although individual providers and their patients are the ones make treatment decisions, the public needs to be assuredof the quality and appropriate use of medicines and medical devices by health professionals and consumers. This can be done through a dedicatednational body to monitor and promote quality medicine and technology use; national essential technologies and medicines lists; drugs and therapeutic committeesin all major hospitals and districts; and financial incentives. Improving accessibility, affordability, availability, safety and accountability in the use of medicines andtechnology requires not only awareness and response from multiple sectors with national governments, but also from industry, academic institutions, healthprofessionals, NGOs, financing agencies, patients organizations and the population at large. A range of partners, primarily WHO, can provide support as needed.
Proposed actions for the WHO Secretariat: (1) Convene key partners to develop efforts to increase access to essential medicines and technologies. (2) Assist inthe development and dissemination of international norms, standards and guidelines. (3) Collect and share best practices in fiscal reform and other policies thatenhance access to essential medicines and technologies. (4) Convene multi-stakeholders to discuss and facilitate innovation in NCD-related medicines,vaccines, diagnostics, medical devices and related technologies.(5) Identify obstacles and opportunities and support their resolution, including throughtechnology transfer, as appropriate. (6) Adapt the WHO Prequalification Programme for NCD-related medicines, vaccines and diagnostics (resource and demandpermitting). (7) Assist countries in demand forecasting for NCD related products.
http://www.who.int/nmh/events/2012/discussion_paper1.pdf
March 16, 2012
US – Food and Drug Administration (FDA): Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program;Availability
Federal Register: Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary AuditReport Submission Pilot Program; Availability
Summary: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary AuditReport Submission Pilot Program.'' This guidance document is intended to provide information on the implementation of the Food and Drug AdministrationAmendments Act of 2007 (FDAAA), which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance document describes how FDA's Centerfor Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this provision of the law.
http://www.gpo.gov/fdsys/pkg/FR-2012-03-19/html/2012-6503.htm
US – Food and Drug Administration (FDA): Modifications to the List of Recognized Standards
Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition ListNumber: 028
Summary: The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDArecognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards,Recognition List Number: 028'' (Recognition List Number: 028), will assist manufacturers who elect to declare conformity with consensus standards to meet certainrequirements for medical devices.
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Standard sectors: “Anesthesia”, “Biocompatibility”, “Cardiovascular”, “Dental/ENT”, “General”, “General Hospital/General Plastic Surgery”, “In Vitro Diagnostics”,“Materials”, “Neurology”, “OB-GYN/Gastroenterology”, “Ophthalmic”, “Orthopedic”, “Radiology”, “Software/Informatics”, “Sterility”, “Tissue Engineering”
http://www.gpo.gov/fdsys/pkg/FR-2012-03-16/html/2012-6389.htm
Le 15 march 2012
Netherlands – Healthcare Inspectorate: Breast implants PIP
Oproep aan vrouwen met borstimplantaten PIP of M-Implants ook van vóór 2001 om zich te laten onderzoeken – Nieuwsbericht – 15-03-2012 Appeal to women with breast implants PIP or M-Implants also before 2001, to be examined The Healthcare Inspectorate requires hospitals and private clinics to women who received breast implants before 2001 or M-PIP implants have been, to call to get
checked and in consultation with the doctor if the implants removed. The occasion is new information that the TV program Zembla has discovered evidence that theFrench manufacturer of the implants even before 2001, has committed fraud. The inspection went to now assume that only the women who from 2001 had PIPimplants, implants were at risk of fraudulent. The Inspectorate did this, because the French control them and all other European inspections had indicated that onlyfrom 2001 with silicone was fraud by the owner. Because the factory is in France, the French inspection the competent authority which made the study of fraud andall European inspection informs. Other European inspectorates warned this is that only the women who had PIP implants since 2001. […]
http://www.igz.nl/actueel/nieuws/oproepaanvrouwenmetborstimplantatenpipofmimplantsookvanvr2001omzichtelatenonderzoeken.aspx
Singapore – Health Sciences Authority: Regulatory controls for medical devices used in clinical trials in Singapore
Regulatory controls for medical devices used in clinical trials in Singapore by Foo Yang Tong – Director – Clinical Trials Branch – Health ProductsRegulation Group – HEALTH SCIENCES AUTHORITY – Workshop on Clinical Development of Medical Devices – 15 March 2012
Content: “Presentation Outline”, “Current Clinical Trials Regulatory Framework”, “Overview of Health Products Legislation”, “Implementation Timeline for SubsidiaryLegislations”, “Interface between Medical Device Regulations and Clinical Trials Regulations”, “CTM (MD) Application Form & TradeNet® Control”, “Regulating ClinicalTrials”
http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/clinical_trials/files_1.Par.31906.File.tmp/HSA%20Regulatory%20Controls%20for%20Medical%20Devices%20Clinical%20Trials%20(15Mar2012).pdf (broken link after publishing)
Ukraine – State administration of Ukraine on medicinal products: In Ukraine mostly authorized medical devices are produced inGermany
Information from “State administration of Ukraine on medicinal products” – Title: “In Ukraine mostly authorized medical devices are produced inGermany”
Text: As for today in Ukraine is established pre-authorization control and state control over compliance with the safety requirements for medical devices. OnJanuary 1, 2012 were registered 6,273 points of medical equipment and medical devices. Among them 864 – domestically manufactured and 5,409 – foreignproducts. When evaluating authorized products by their country of origin, then it becomes clear that the most frequently these products are from Germany (1151),Ukraine (980), USA (864), China (545) and Russian Federation (484). According to the nomenclature codes, the main groups of registered domestic and foreignmedical devices , are: (1) 8,89% – devices used in medicine, surgery, dentistry (9018 90 85 90), (2) 4,62% – wadding, gauze, bandages and similar articles (forexample, bandages, adhesive plasters, mustard plasters), (3005, (3) 4,27% – diagnostic or laboratory reagents (3822 00 00 00).
http://www.diklz.gov.ua/en/dept/ukraine-mostly-authorized-medical-devices-produced-germany
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For further information
Application for qualification as a medical product – 12.01.2011 http://www.diklz.gov.ua/en/page/application-qualification-medical-product Application for the state registration (re-registration) of medical equipment and medical devices – 12.01.2011 http://www.diklz.gov.ua/en/page/application-state-registration-re-registration-medical-equipment-and-medical-devices
International – International Medical Device Regulators Forum (IMDRF): Five work items agreed for international progression
IMDRF – Media Statement –Successful Launch to the IMDRF Text: Good progress and a commitment to advancing regulatory convergence and public health marked the inaugural meeting of the International Medical Device
Regulators Forum (IMDRF), held in Singapore from 28 February to 1 March 2012. Regulators from Australia, Brazil, Canada, Europe, Japan, and the UnitedStates of America were joined by regulatory observers from China and the Russian Federation and by the World Health Organization for the purpose ofputting the new Forum into operation and planning the transition of several key items from the Global Harmonization Task Force. Notable outcomes of the meetingincluded confirmation of initial membership, the adoption of a Terms of Reference and robust workplan, agreement on the elements of an operatingprocedures document and a constructive dialogue with stakeholders. The Forums chair, Dr. Larry Kelly, conveyed a number of key messages to the approximately100 participants in the public session on day two of the Forum, including the value of GHTF documents, the importance of establishing strong partnerships withaffiliate organizations, a commitment to transparency and the vital role industry and other vested stakeholders will play in contributing to the development of newwork items and the overall success of the new Forum. Dr. Kelly noted that the Terms of Reference foresees the expansion of the Management Committeeto other regulators, with criteria to be established in operating procedures. The chair ended the public session by thanking participants for their comments andunderscoring the Management Committee's commitment to achieving concrete deliverables within a 18 month period on priority work items with a view toprogressing regulatory convergence and to promoting access to safe and effective medical devices globally. The Outcomes Statement provides a more detaileddescription of the inaugural meeting, including adopted new work items. The next meeting of IMDRF will take place in Sydney, Australia on 25 to 27 September2012.
http://www.imdrf.org/pdf/media-2012-launch-120315.pdf
International Medical Device Regulators Forum – Outcome Statement – Meeting 1, 28 February to 1 March 2012
The Management Committee agreed on a Terms of Reference document […] and agreed also to develop a formal strategy for the management and maintenance ofGHTF documents.
[…] The [seven] following topics were […] discussed: “A review of the NCAR system, Roadmnap for implementation of a UDI system”, “Standardized submissionrequirements for pre-market assessment of medical devices”, “Medical Device Single Audit Program (MDSAP)”, “Non-clinical and clinical evaluation regardingnanomaterials”, “International Standards recognized by IMDRF Management Committee members”, “Guidance on how to determine risk/benefit analysis”,“Regulated Product Submission”.[…]
The Management Committee agreed to progress five work items.
The five initial IMDRF work items for progression
Work Item Work GroupMembership
Co-ordinator
A review of the NCAR systemThe NCAR Exchange Program facilitates the exchange of relevant post market safety information on medicaldevices with global distribution. The aim is to trigger rapid adoption of field safety corrective actions in allconcerned geographies to avoid death or serious deterioration of health, when relevant. This work will reviewthe current arrangements and advise on opportunities for improvement and possible expansion of the systemto also include select pre-market decisions and other post-market actions.
Regulator Isabelle Demade Europe
Roadmap for implementation of UDI systemThis item seeks to define the path to implementing a globally harmonized approach to a uniform deviceidentification system, and builds on the earlier work of GHTF.
Regulator andstakeholdersmembership
Laurent Selles, Europe
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The five initial IMDRF work items for progression
Work Item Work GroupMembership
Co-ordinator
Medical Device Single Audit Program (MDSAP)The Work Group will develop a standard set of requirements for auditing organizations performing regulatoryaudits of medical device manufacturers' quality management systems. The document will be applicable tocompetent authority auditing groups/inspectorates, as well as third party organizations that conduct suchaudits. This is an initial critical step in establishing a single audit program. This action will complement thecurrent IS0 13485 revision process under which IMDRF seeks modifications to achieve a harmonizedstandard amongst its members.
Regulator membership Kim Trautman, US
Recognized standardsThe task is to create a list of International Standards used for medical device regulatory purposes that arerecognized by IMDRF Management Committee members.
No Work Crouprequired. For initialinformation gatheringphase
Matthias Neumann, Europe
Regulated Product SubmissionThis work will take advantage of a project undertivay internationally that will result in a messaging standardthat supports the electronic transmission of regulatory submissions. This work will define a common `Tableof Contents' for medical device regulatory submissions as a first step in defining a common data set.
Regulator only andregulator andstakeholder membership
Mike Ward, Canada
IMDRF Terms of Reference –Date 1 march 2012 […] Objectives of IMDRF: The objectives underpinning the goals of IMDRF are to: ”Accelerate international medical device regulatory convergence”, “Support
innovation and timely access to safe and effective medical devices globally”, “Promote open discussion and the sharing of best practices among regulatoryauthorities responsible for medical device regulation”, “Facilitate frequent exchange of policy and regulatory information of common interest to regulatoryauthorities”, “Provide opportunities to identify commonalities and develop approaches to overcome unnecessary regulatory barriers”, “Promote prospectiveconvergence in arecs of advanced and innovative technologies”, “Enhance communication, information sharing and scientific exchange among regulators and abroad range of stakeholders”, “Establish develop dialogue with other relevant organizations” […]
http://www.imdrf.org/pdf/imdrf-meeting-120228.pdf
