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TÜV SÜD Japan Slide 113-09-27

J-PAL Overviewand Update

Boston, USA2013-10-02

Rie NakaharaManager, Active Medical Devices

TUV SUD Japan

Contents for Today’s Presentation


- PAL Overview

- Updated Information on Revised PAL(Draft)



- PAL Overview


Japanese Regulation System


0. Constitution

1. Law (e.g. PAL)

2. Governmental Ordinance

3. Ministerial Ordinances4. Ministerial Notices5. Announcements6. Office Memos

01

2

3456


1. Pharmaceutical Affairs Law (YAKUJI-HO)

vv Established on 10 August 1960v Major revision on 31 July 2002v Minor revision on 11 June 2003 (The latest)v Both of the revisions in 2002 & 2003 are effective on 1 April 2005

v ScopeØ Drugs (Medicine) including In-vitro

diagnostic reagentsØ Quasi-Drugs (Sanitary & toiletry products)Ø CosmeticsØ Medical devices

Terminology


Abbreviations Formal notation meaning

JIS Japanese IndustrialStandard

National standard in JapanMost of JIS are identical to international standard (ISO or IEC), but a few JIS arenot identical nor modified.JIS is used for certificate assessment criteria of Medical Device forcertification

JMDN Japanese MedicalDevices Nomenclaturecode

Code assigned to each medical device term based on GMDN code

JGMP orJ-GMP

Japanese GoodManufacturing Practicerule

MHLW Ordinance No. 169 in 2004Some of governmental officers want to abbreviate the ordinance as “QMSordinance” or “QMS rule”, but we use this abbreviation.

MAH MarketingAuthorization Holder

An organization that has legal responsibility in JapanSimilar to “legal manufacturer” under MDD or CMDR

MHLW Ministry of Health,Labour and Welfare

Japanese government, which is responsible for the medical attention

PAL Pharmaceutical AffairsLaw

Law, regulating Drugs (Medicine) including In-vitro diagnostic reagents, Quasi-Drugs (Sanitary &toiletry products, Cosmetics and Medical devices

PMDA Pharmaceuticals andMedical DevicesAgency

An Independent Administrative Legal Entity, which is responsible for approval ofall of medicines, a certain type of medical devices and IVD reagents

RCB RegisteredCertification Bodyunder PAL

Third party, who has authority to certify a certain type of medical devices and IVDreagents.13 RCBs exist in Japan as of 2013 Oct. TUV SUD J is one of them

PAL Scheme


Controlled(Contract)

Application doc. (STED)

Product CertificateClass II

RCB

Japan

J-GMP audit (QMS)Class III / IV

MAH

Manufacturing site

Current Change System


Change Type Actions

Significant Change Significant Changes on device configuration,materials, performance ;New Application is necessary

Partial ChangeApplication

Review by PMDA or RCB is necessaryApproval of Certification is necessary, beforethe changed devices is marketed in Japan

Minor ChangeNotification

Just NotificationApproval or Certification is NOT necessary.

Relevant announcement Yaku Shoku Kihatsu No.1023001‘ Procedures for Changes of Medical Devices ‘ issued on Oct 23, 2008

Marketing Approval or Certification


IVDreagents

MedicalDevices

Approval orCertification

Class I Both are not necessary(Notification to PMDA)

Class II

If certificationassessmentcriteria isavailable

If certificationassessmentcriteria isavailable

Certificate application toRCB

If not available If not available Approval application toPMDA

Class IIIApproval application to

PMDAClass IV

PAL in comparison to Other Regulations


InvolvedOrganizations

ProductSafety

QMS Vigilance

USAFDA

3rd Party reviewer510 (k)PMA QSR MDR

Japan

MHLW+ PMDA

& Local Gov(Prefecture)

+ 3rd Party(RCB)

Approval orCertification

QMS/GMP(≠ISO13485)

Adverseevent

reporting

EU

Competentauthorities of

member statesNotified Body

MDDCE Marking

MDDEN ISO13485

MDDVigilanceSystem

Canada Health CanadaRegistrar

CMDR DeviceLicense

CMDRISO13485 CMDR



- PAL Overview



PAL will be revised soon・Decision @ Cabinet Meeting was made in 2013 May・Movement to Revised PAL

Due to insufficient deliberation, revised PAL was not concluded inthe Regular Diet Session (No. 183) till 2013/06/26 .Revised PAL will be taken into deliberation in the Nextextraordinary Diet Session in Mid October 2013.

Revised PAL will be named’Law for Ensuring Quality, Effectiveness and Safety of Medicines,

Medical Devices and So On’

Why PAL needs to be to revised ?


Drug

Pharmaceutical Affairs Law

MedicalDevice

Law for Ensuring Quality, Effectiveness andSafety of Medicines, Medical Devices and So On’

Control under separate provisions

Once the constituents of chemicalcompounds, changes are seldomhappened.

Control under the same Provision

e.g. For active Medical Devices, aggregate ofelectrical engineering technologies. Developwith repeated design and improvements.

Medical Devises V.S Drug


Medical Device DrugCompany Size Medium and small sized

companies (about 80%)Multinational, global companies

Product Types About 300,000 items 17,000 itemsUsage Technique is required Usage and Dosage ControlEffectiveness Also depends on user’s

techniquesDepends on individual difference

Materials Various materials, materialtechnologies involved

Natural substances, chemicals

Design andDevelopment

Upon Market Needs, havedesign change & improvement

No Change after being Marketed

Life cycle 18-24 months (for shorter ones) e.g. more than 10 yearsMaintenance・Repair

Necessary NOT Necessary (Storage ControlOnly)

Regulation Currently PAL

(Quoted from MHLW issued materials, Mizuho Bank ‘Mizuho Short Industry Focus 2013/07/22)

Please Keep In Mind……

TÜV SÜD Japan Slide 15

The Contents of this presentation does NOT reflect the final fixedversion of revised PAL . Information will be changed and updated.Please pay attention to the updated information

Although determined at Cabinet Meeting, the revised PAL is still NOT yetdeliberated.

• Revised PAL (Draft) is under active discussion• Concrete and Detailed implementations are still NOT determined yet.

Additional new bullet points might be added.

Bullet Points of Revised PAL


1. Constructing regulatory scheme, considering characteristics ofMedical Devices.

2. Encourage New Entry into Medical Device Market(Promoting design and development of Medical Devices,Faster Review Process, Liability Relief)

3. Global Harmonization



Simplify Partial Change System・Design Control will be audited in QMS on-site audit for all Medical Devices.(Design Change is reviewed on-site)・MAH is also audited for QMS (Now only for Manufacturing Sites)

Time consuming Change SystemPartial Change : Preparation of Documents, Submission,Review and Approval

1. Constructing regulatory scheme, considering characteristics of MedicalDevices.

Image


AB A

B

Current Future

A：J-GMP audit (QMS) :B：Device change (Partial Change)



a) For Manufacturer’s License :

-Registration / FMA (Foreign Manufacturer Approval) →Listing

• Company only doing design and development:

-Listing will be necessary.

2. Encourage New Entry into Medical Device Market , Liability Relief(Promoting design and development of Medical Devices, Faster ReviewProcess)



Foreign Manufacturer Registration(Under Current PAL scheme)

Form to be submitted to PMDA( Under JPAL)


Address in Japaneseand local language.(in case of legal entity,the main office’s)

Name in Japaneseand local language.(in case of legalentity, the name ofcompany andpresident)

• Form No. 18• Application for Registration of Foreign Manufacturing

site of(Medicines, Quasi-Drugs, Medical Devices)

• Name of the site• Location (address) of the site• Category of registration• Outline of building and facilities• Responsible person of the site

– Name– Private address

• Disqualification clause of Applicant (in case of legalentity, describe its board members)1. Has it been canceled the license or registration?2. Has someone been assigned penalty of prison or

over?3. Has someone violated PAL or related regulations?4. Is someone in the dock of commencement of

guardianship?• Note• Statement “Hereby, I apply for the registration.”• Date

Documents to be attached


1. Medical certificate that describes if the applicant (in case of legal entity, the board member) hasmental illness or be addicted to drugs

2. Job history of the responsible person at the site3. List of manufacturing products (i.e. products scheduled to be exported to Japan) and Description

of manufacturing process4. Description of building and facility in the manufacturing site5. If radioactive medicine is manufactured, kind of the radioactive medicine and summary of

equipment to deal the radioactive medicine6. If the country, where the manufacturing site located in, has system license of MAH, manufacturing

site, approval or certificate of product, or equivalent, a copy of such license or approval/certificate

• The MAH can take manufacturing site’s duty for application of registration.


• b) Expansion of Certification Scope of 3rd Party (RCB)

Classification Class1 Class 2 Class 3 Class 4

Definition

Extremely little risk tothe human body evenif they fail

Relatively little risk tothe human body evenif they fail

Relatively high riskto the human body ifthey fail

Medical devices thatare highly invasiveupon the patient andmay directlyendanger thepatients’ life if they fail

ExamplesIVD Instrument,Surgical Knife・Forceps, X ray Films

Ultrasound Equipment,Blood Pressure Meter(Electrical), MRI

Dialyzer, respirator Pace Maker, Artificialheart valve

Current Notification 3rd PartyCertification Approval （Reviewed by PMDA）

Future NotificationApproval

（Reviewed byPMDA）

3rd PartyCertification



• C)QMS Audits will be streamlined-QMS conformity attestation (in Japanese, Kijun Tekigo Sho)will be issued to QMS including MAH and manufacturers for theproduct category.-Audit is NOT done by prefectures any more

2. Encourage New Entry into Medical Device Market , Liability Relief(Promoting design and development of Medical Devices, Faster ReviewProcess)

Image of Kijun Tekigo Sho (QMS Conformity Attestation )


MAH

Sterilizationcontractor

Design FacilityManufacturer Packaging SterilizationContractor

Design

Foreign ManufacturingSite

MAHContract

QMS Conformity Attestation is issued(for Product Category) QMS Conformity Attestation is issued

(for Product Category)


Stand alone Software will be regulated

Changed to

Hardwarepart

Software part（program）

Software alone itself is NOT regulatedunder current JPAL .

Regulated with combination of softwareand hardware part.

Program itself will be regulated.※already regulated as Medical

Device in EU, and USA

Current J PAL

Stand alone software

Software Part（program）

Revised PAL



Intendedfordiagnosisandtreatment

Category Definition Product Example Japan EU USASoftware aspart of MedicalDevice

Embedded Software in to MedicalDevice

Embedded software into CT※ ○ ○

Optional Software for MedicalDevices

Software installed for MedicalWork Station (Separately Sold) ○※ ○ ○

Stand aloneMedical useSoftware

Application software for Medicaluse ①Software alone has theEffectiveness for Medical purpose,and intended for diagnostics. Soldas software alone, intended to beinstalled in the general purposehardware such as personalcomputer etc.

Software currently regarded asNon Medical Devices

×↓○

○ ○

Application software for Medicaluse ②Processing of patient clinicalinformation and image informationcollected from Medical Devices isNOT done. However, for diagnosticpurposes, intended for datastorage, transfer, or displaly.Includes. Sold as software alone,intended to be installed in thegeneral purpose hardware such aspersonal computer etc.

Software currently regarded asNon Medical Devicee.g. PACS(Picture Archiving andCommunication System), Serversoftware, biological test software ×

↓○

○ ○

※Regulated as software installed Medical Devices



Current QMS : ≠ ISO 13485 (some delta parts)Revised : ＝ISO 13585 (????), JGMP Chapter 3 is deleted


Summary of Revised JPAL


Points Current PAL Revised PAL (Draft) Expected Effects

Manufacturer License License / Registration Listing Encourage new entry

Expansion ofCertification Scope of3rh party

Class 2 withconformityassessment criteria

Current Class 2 PlusPart of Class 3

Faster ReviewProcess

Product ScopeChange

Stand alone Softwareis NOT in the scopeof current PAL

Stand alone Software isin the scope of revisedPAL

Global HarmonizationActivate design anddevelopment ofstandalone software

QMS Audit Product based Product Categorywith the concept of KijunTekigo Sho (QMSConformity Attestation

Streamline QMSFaster ReviewProcess

≠ ISO 13485(Delta Parts)

＝ISO 13485 (?????)Chapter 3 will bedeleted

Global Harmonization

Current Situation


• Decision on Revised PAL was made @ Cabinet Meeting on 24 May2013

• Due to insufficient deliberation, revised PAL was not concluded inthe Regular Diet Session (No. 183) till 2013/06/26 .

• Revised PAL will be taken into deliberation in the Next extraordinaryDiet Session in Mid October 2013.

• Date of Enforcement : The date, which will be defined in thegovernment ordinance within one year after the promulgation

Will the PAL Really be Revised ?


On 2013/07/26, the MHLW Vice Minister, Mr. Kenya Akiba, visited TUV SUD JapanMHS and obtained information on current RCB task and our implementation.

TUV-SUD Japan CEODr. Andreas Stange

MHLW Vice MinisterMr. Kenya Akiba

TUV SUD Japan Activities for the Revised PAL


• As ARCB (Association of Registered Certification Body) Rep.,-Actively participate in opinion exchange sessions with MHLW andindustry-Negotiate several certification issues with MHLW- A member of ‘Medical Device Task Force’, ‘ QMS Working Group’, and‘ Product Category Study Group’(Ms. Eiko Tabuchi)

• -A member of Stand Alone Software Study Group for the Revised PAL(Mr. Kenji Kino, and Mr. Yukihiro Nakata)★Only TUV SUD Japan and UL Japan out of 13 RCB, participate in thisstudy group

For Updated Information


- Med-Info. will be issued once the revised PAL isfinalized after the Diet deliberation

http://www.tuev-sued.de/industrie_konsumprodukte/tools_und_downloads/broschuerendownload/medinfos

Thank you for your attention!ありがとう

谢谢

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