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21 May 2013
World Metrology Day Symposium in Peru
Dr. Peter LeeKorean Advisor
METROLOGY CONTROL OF MEDICAL DEVICES
Overview
♦ Medical Device Regulations in Korea
♦ Medical Regulatory Control
♦ Comparison with legal metrology control
♦ Complementary control2
Medical Device Regulations1. Medical Device Act
– To administer medical devices efficiently– To improve the public health
2. Enforcement Ordinance(Decree)– Presidential Decree– Regulate items authorized by the Medical Device
Act and necessary items regarding to the enforcement
– Medical device committee operation, etc.
3
Medical Device Regulations
3. Enforcement regulation– Ministerial Decree of the Ministry of Health,
Welfare and Family– Regulate items authorized by the Medical
Device Act and Enforcement Decree, and necessary items regarding to the enforcement
4
Medical Device Act Establishment
• Announced in May 29, 2003 as a Law, No. 6909• To be put in force in May 30, 2004• Reasons for enacting Medical Device Act.
– To become independent from the Pharmaceutical Affairs Act that focuses on drugs and quasi-drugs
– To improve the regulatory system rationally and efficiently for medical devices
– To enhance its international harmonization for medical device regulatory system
5
Medical Device Act Structure
• 8 chapters, 7 sections, the full text 47 articles, Addendum 6 articles– Chapter 1, General provisions(Purpose, Definition,
Designation and Classification)– Chapter 2, Medical device Committee– Chapter 3, Manufacture of Medical device, etc.
(Manufacturing Business, Importing Business, Repairing Business, selling and Rental Business)
6
Medical Device Act Structure– Chapter 4, Management of Medical devices, etc.
(Standards, Labeling and Advertising, Handling)– Chapter 5, Vigilance (Tracking, management of
Adverse events)– Chapter 6, Supervision (Inspection, destroy, order for
cease of use, cancellation of license, etc.)– Chapter 7, Supplementary Provisions (Delegation and
commission of Authorities, Protection of Submitted information, etc.)
– Chapter 8, Penalty (Penalty, Administrative Fine, etc.)
7
Each Articles Subjects of Medical Device Act
Article Subject Article Subject Article Subject
1 Purpose 9 Re-evaluation 17 Matters to be Observed by Seller, etc.
2 Definition 10 Authorization of Clinical Trial Plan 18 Standard Specifications
3 Designation and classification 11 Amendment to License, etc. 19 Information to be stated
upon Container, etc.
4 Relationship with other Laws 12 Duties of Manufacturers 20 Information to be stated
upon Outer Package
5 Medical Device Committee 13Notification of Discontinuation of Business, etc.
21 Information to be stated in Package Insert
6 License of Manufacturing Business, etc. 14 License for Importing
Business 22 Cautions on Labeling
7 Conditional License 15 Notification of Repairing Business 23 Prohibited Labeling and
Advertising
8Re-examination of Newly Developed Medical Devices, etc.
16 Notification of Selling Business, etc. 23-2 Review of Advertisement
8
Article Subject Article Subject Article Subject
24 General Prohibitions 32Cancellation of License, Suspension of Business, etc.
40 Succession to the status of Manufacturer, etc.
25 Medical device Subject to Tracking 33 Administrative Penalty 41 Renewal of Product
License or Notification
26 Record Keeping, Retention of Records, etc. 34 Hearing 42 Fees
27 Management of Adverse Events 35 Medical Device Surveillance
officer 43 Penalty
28 Report, Inspection, etc. 36Research and Development to Advance Medical device Industry
44 Penalty
45 Penalty
29 Order for Testing 37 Delegation and commission of Authorities 46 Parallel Punishments
30 Order for Destroy, etc. 38 Protection of Submitted Information 47 Administrative Fine
31 Order for cease of use, etc. 39 Special Measures for Veterinary devices Addendum
Each Articles Subjects of Medical Device Act
9
No Product Group Applicable Product Designations (Examples)
1 Treatment table Operating and treatment table, Bed for medical use,Unit and chair, dental, Table and chair, examination/treatment, ENT
2 General Instrument Medical light and lamps, Neonatal incubator,Film developer for medical use
3 Metal sheet apparatus Medical sterilizing apparatus, Medical water sterilizers,Medical chamber, Blood bank refrigerator, Thermostat, liquid drug
4 Anesthesia apparatus Anesthesia apparatus, Respiratory apparatus
5 Artificial internal organ apparatus
Artificial internal organ apparatus(Cardiopulmonary bypass system, Pacemaker,Haemodialysis system, Cardiopulmonary bypass system roller pump, etc.)
6 Radiologic device CT system, full body, Mammographic x-ray system, PET system
7 Non-ionization diagnostic device MRI system, full-body, super conducting magnet
8 Radiation protective device
Radiation shield, spectacles,Radiation shielding apron
9 Physical devices for medical use
Stimulator, microwavephototherapy unit, ultravioletvelocitometer, Carvernosal artery
10 Cardiovascular devices Defibrillator, implantableBlood recovery collection container, auto transfusion
10
Medical Device Products Group
No Product Group Applicable Product Designations (Examples)
11 Urology devicesLithotriptor, external ultrasonicLithoriptor, internal, laserIncontinence, diagnostic
12 Patient transportWheelchair, manually-operated lift, Patient transfer, electrically-poweredDisability scooter, automated
13 StethoscopeStethoscope, mechanicalultrasonic stethoscopeOesophageal stethoscope, mechanical
14 Clinical thermometricsystem
Thermometer, capillary, mercuryThermometer, colour-indicatingThermometer system, infrared
15 External diagnosticdevice
Flow type clinical chemistry automated analyzer.Calcium analyzer, CentrifugeDNA amplifier, Analyzer, blood gases
16 Perception and Organsdiagnostic devices
Sphygmomanometer, manual, aneroid sphygmographUrine analyzer, Electrocardiographic analyzer
17 Speculums for medical use
Adapter, endoscope elementStomatoscope, videoOesophagoscope, rigid/Laparoscope, flexible
Medical Device Products Group
11
No Product Group Applicable Product Designations (Examples)
18 Surgical Instrument
Suture instrument only, reusablePnemothorax apparatus,Knife, manually-operated, reusable scissorscurettes, clamp, Forceps, Saw, chisel, Mallet
19 Electro surgical device Electro surgical system, general-purposeinstrument, ultrasonic surgical
20 Laser apparatusfor medical use
Laser, surgicalLaser surgical unit, Krypton
21 Needle for Syringes and puncture
Needle, aspiration/injection, reusableNeedle, artery, single-useLancet, automatic, single-use
22 SyringesInjector, medication/vaccine, syringeInjector, medication/vaccine, needleless, gas-poweredDental syringe
23 Infusion instrumentsCatheter, rectal, continent ileostomyCatheter, general-purpose, balloonblood collection container, Infusion pump
24 Medical device for orthopedics
Traction unit, manually-operated powered orthopedic devicevibrators for medical use
25 Dental deviceDental engineDental polymerization activator-ultravioletDental laboratory casting unit12
Medical Device Products Group
No Product Group Applicable Product Designations (Examples)
26 Sight corrective Lens Sight corrective spectacles, Trial lens
27 Hearing aid Hearing aid, bone-conductionImplantable hearing aid
28 Acupuncture andmoxibustion apparatus
Acupuncture needle, reusableMoxibustion apparatus, electrical
29Magnetic inductionapparatus for medical use
Magnetic pulse stimulatorElectromagnetic therapy stimulator
30 Medicinal substance-Producing equipment Alkali water producing equipment
31 Radiographic supplies X-ray film, medical, screenX-ray fluorescent screen
32 Suture and ligatureSilk suture, non-sterileSuture, cottonLigature, absorbable
33 Orthopedic materialsProsthesis, ankle, internal total Knee prosthesis, internal, totalOrthopedic bone screw, non-biodegradable
34 Human tissue and organ substitute
Prosthesis, Vascular, PeripheralCardiovascular patch, syntheticBreast prosthesis, internal, gel-filled
13
Medical Device Products Group
No Product Group Applicable Product Designations (Examples)
35 SplintsSplints, general purposeSplints, Denis BrownSplints, extremity, inflatable
36Test chart for visualacuity and color blindness
Visual acuity chartcolor discrimination chart, ophtalmic
37 Contraceptive deviceContraceptive, condom, malePessaryContracoptive, intrauterine device
38 Surgical supplies Glove, surgicalBandage, Compression
39 Dental Materials
Alloy, foil, noble metalAlloy, metal-ceramic restorative systems, noble metalpure metal, filling, goldceramic, all-ceramic, powder/paste/blankMaterial, dentine, desensitizer
Medical Device Products Group
14
Legal Metrology and Metrology System
Managing
measurement & metrology
Formulating policy
in measurement & metrology
OIML-MAA, ILAC-MRA
Legal metrology Measurement standard
Measure Act National Standards Act
KRISS
Establishment of thenational measurement standards
- Establishment & revision of verification standard
- Verification standard of
prepackaged good
• Type approval
• Verification• of manu-
facturing/importing
•Re-verification
KTC
Local government(234)
• Registration of manufactur
-ing & repair business
• Periodic inspection
• Surveillance of prepack
-aged goods
• Checking implementation
of SI unit use
KOLAS, KAS
KASTO
- Assessment body of KOLAS- Educational institution of
KOLAS & KAS
- Calibration lab (184) - Authorized testing lab (366)- Authorized inspection lab (44)
Assessment
KASTO
• Conformity of prepackagedgoods (k-mark)
• Training of government officials
ROTA
• Verifi-cation
of SPEEDGUN
KERI
• Type appro-valWattHour
meter
15
Summary of Measures Act18 items of legal measuring instruments
(13 items for transactions, 2 items for medical use, 3 items for law enforcement)
Type Approval
Type Approval
• 18 items(by designated institution
OIML-MAA
18 items18 items
Instrument error inspection
Surveillance of local government
Verification
Prepackagedgoods
• 26 items of daily necessities
• allowed tolerance- managed by local government
• Self-declaration of conformity( -- mark)- managed by KASTO
Use of SI units
• Prohibited the use of non-SIunits (500,000 KRW Fine)
• Manufacturing and importing of non-SI unit measuring instruments(1 year prison or 5,000,000 KRW
Fine)
16
What’s the global trend ?
Why we still need legal metrology control?
What are their differences ?
How to achieve complementary control ?
17
Main Purposes of Regulatory ControlMedical Regulatory System1
• Ensure a high level of protection of public health and safety
• Public Trust and confidence in Medical Devices based on safety and performance of such devices Legal Metrology2
• Protect the interests of individuals and enterprises; national interests; public health and safety, including in relation to the environment and medical services; meet the requirements of international trade
• Providing confidence on Measurement Results of medical Device
1. Principles of Conformity Assessment for Medical Devices, SGI Final Document GHTF/SG1/N40:2006, Global Harmonization Task Force
2. Elements for a Law on Metrology, OIML D1,2004 edition
18
Medical Regulatory Controls by RiskMedical regulatory controls are proportional to the level of risk associated with a medical device.
The level of regulatory control increases with increasing degree of risk
The risk depends substantially on• intended purpose of medical device• the effectiveness of the risk management techniques applied duringdesign, manufacture and use• Intended user(s).mode of operation, and/or technologies
Classification of Medical Device by Low risk, Low-moderate Risk,Moderate-high Risk, high risk (I, II, III, IV)
19
Conformity Assessment Elements for Medical Device※
• Quality Management System
• Technical Documentation
Device safety and performance• Registration
※ Principles of Conformity Assessment for MedicalDevices, SGI Final Document GHTF/SG1/N40:2006
20
Quality Management System• ISO 13485, 21 CFR Part 820 ……
• Ensure that medical devices will be safe and perform as intended by the manufacturer
• Type examination is acceptable in some cases
• System for post-market surveillance which includes complaint handling, post-market vigilance and corrective & preventive actions is required to ensure the continued conformity
21
Sub-systems of Quality Management System• Management
• Design and Development
• Product Documentation
• Production and Process Controls
• Corrective and Preventive Actions (CAPA)
• Purchasing Controls
• Documentation and Records
• Customer Related Processes Subsystem22
Device safety and performance• Chemical, physical and biological properties.• Infection and microbial contamination.• Manufacturing and environmental properties.• Devices with a diagnostic or measuring function.• Protection against radiation.• Requirements for medical devices connected to or equipped with an energy source.• Protection against mechanical risks.• Protection against the risks posed to the patient by supplied energy orsubstances.• Protection against the risks posed to the patient for devices for self-testing or selfadministration.• Information supplied by the manufacturer.• Performance evaluation including, where appropriate, clinical evaluation
23
Devices with a diagnostic or measuring functionDevices with a measuring function, where inaccuracy could have a significant adverse effect on the patient, should provide sufficient accuracy, precision and stability for their intended purpose of the device. The limits of accuracy should be indicated by the manufacturer.
Diagnostic devices should provide sufficient accuracy, precision and stability for their intended use, based on appropriate scientific and technical methods. In particular the design should address sensitivity, specificity, trueness, repeatability, reproducibility, control of known relevant interference and limits of detection, as appropriate
24
The definition of Medical DeviceAny instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of such as
· diagnosis, prevention, monitoring, treatment oralleviation of disease,
· diagnosis, monitoring, treatment, alleviation of orcompensation for an injury, and so on …….
25
Subject to legal metrology control• R7 Clinical thermometers, mercury-in-glass with maximum device• R16-1 Non-invasive mechanical sphygmomanometers• R16-2 Non-invasive automated sphygmomanometers• R26 Medical syringes• R78 Westergren tubes for measurement of erythrocyte sedimentation rate• R89 Electroencephalographs - Metrological characteristics - Methods and equipment for verification
• R90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification• R114 Clinical electrical thermometers for continuous measurement• R115 Clinical electrical thermometers with maximum device• R133 Liquid-in-glass thermometers• R135 Spectrophotometers for medical laboratories• Ophthalmic instruments – Impression and Applanation Tonometers Version 4 ,November 2009
26
Controlled medical device
Medical regulatory control- By definition, cover extensively
Legal metrology control- Designated by legal metrology authority(only Thermometers , Sphygmomanometersare controlled by the Act in Korea)
27
Conformity assessment
Medical regulatory control- By Risk
Legal metrology control- Uniformity- Risk assessment for metrological supervision
28
Technical Requirements
Medical regulatory control- Extensively, cover safety and performance
issues
Legal metrology control- Accuracy(Safety, software identification, EMC, Clinicalevaluation: Control by Medical Device Act in Korea)
29
The responsibilities of StakeholdersMedical regulatory controlRegulatory Authority:Review document and audit manufacturerManufacturer:Demonstrate safety and performance of medical device by establish and maintain QMS, prepare Technical Document, registration
Legal metrology controlRegulatory Authority:Verify every medical device usually by testing and evaluation
Manufacturer: have the device pattern approved, verified before placing on the market, registration
User:Maintain the accuracy of device30
Registration Design Manufacturing In Service
PRE-MARKERT POST MARKET
MedicalRegulatoryControl
•Manufacturer•Medical device
•QMS(ISO 13485)(Type Approval)•TechnicalDocumentation
•QMS•TechnicalDocumentation
•QMS
LegalMetrologyControl
•Manufacturer•Installer•Repairer
•Type Approval •Initialverification•(QMS, ISO 9000)
•Subsequentverification•Inspection•Marketsurveillance•Fieldsurveillance
Comparison Conformity Assessment Elements
31
Complementary ControlUnderstand what medical regulatory system could reallycover in the Republic of Peru.
Identify the needs to undertake complementary control
• What is the type of medical device needed to be subjectto legal metrology control ?• What medical regulatory control can’t do?• Does management quality system ensure the continuedaccuracy of device in use ?
Avoid duplicate control
32