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© Nanotec Spindler Co., Ltd. 1

The Pharmaceutical Affairs Law

Registration No. : AI

Nanotec Spindler Co., Ltd

Nov.14, 2007

Under Ministry of Health, Labor and Welfare (MHLW)


Introduction

By April 1, 2005, the revised Pharmaceutical Affairs Law (PAL) came into force in Japan for supervision of manufacturing and distribution of medical devices.

The major revisions of PAL:1. Marketing Approval Holders (MAH)

2. Introduction of the third party certification body for

part of class II and InVitro Diagnostic Devices

Registration No. “ AI” for Spindler

3. Harmonization with European pharmaceutical policies.


Achievement ： Fundamental reconstruction of policy regarding improvement

of safety for medical devices in market

Expand of controlled area •Manufacturer ( factory) and (factory and sales)•Importer ( sales)•Packing, labeling, storage warehouse Introduction of certification by third party

•Comply with Essential Requirement

•Comply with technical conformity standard ( ex.JIS)

•EMC evaluation is mandatory required

•Comply with QMS(GMP) based on ISO13485:2003

Revision Points

International Harmonization

Revolution of Scheme


Introduction of third party scheme

PMDA/Kiko

PMDA/ KikoIncorporated Administrative Agency -The Pharmaceutical and Medical Devices Agency

TPCB

Apply to local government

Investigator of product

Class III, IVSpecially Controlled Medical Devices

Class IIControlled Medical Devices

Class IIDesignated Controlled Medical Devices

Class IGeneral Medical Devices

ClassificationCategory


What is “ Designated Controlled Medical Devices” ?

Controlled medical devices which are certified by TPCB according to criteria conformity certificationwhich prepared by MHLW （Criteria conformity certification) Article23-2The Minister may establish necessary standards after seeking the opinion of *PAFSC in order to regulate the properties, quality and performanceof medical devices. Article 41-3( Essential Requirement ) *The Pharmaceutical Affairs and Food

Sanitation Council


ARCB (Association of Registered Certification Bodies )

Third Party Certification Body Chapter 4-2 Article23 ～

14 Bodies registered

Scope of certificationDesignated Controlled Medical Devices(21 product categories and IVD )

attention! registration scopes are different depend on bodies.


Scope1. Active Implantable Medical Device applicable JIS T601-1 2. Implantable Medical Device not applicable JIS T0601-13. Anaesthetic and Respiratory Device applicable JIS T0601-14. Anaesthetic and Respiratory Device not applicable JIS T0601-15. Dental Device applicable JIS T0601-16. Dental Device not applicable JIS T0601-17. Medical electrical device8. Institutional Medical Device applicable JIS T0601-19. Institutional Medical Device not applicable JIS T0601-110.Non Active Medical Device applicable JIS T0601-111.Non Active Medical Device not applicable JIS T0601-112.Ophthalmology and Vision Devices applicable JIS T0601-113.Ophthalmology and Vision Devices not applicable JIS T0601-114.Re-use medical device applicable JIS T0601-115.Re-use medical device not applicable JIS T0601-116.Single time use device applicable JIS T0601-117.Single time use device not applicable JIS T0601-118.Home use massage device and electrical medical devices and its relating device19.Hearing Aid20.Radiation and diagnostic imaging device applicable JIS T0601-121.Radiation and diagnostic imaging device not applicable JIS T0601-1in-vitro diagnostic device


All category register

Nanotec Spindler Co., Ltd.TUV Rheinland Japan

TUV Japan Sud Group

BSI Japan


Categorize Medical Devices

All medical devices ..... 4044 productsControlled Medical Devices Class II …... 1785 productsDesignated Controlled Medical Devices(Class II with essential requirementsfor certification by third party certification body)

…… only 396 products!!

(as of 28.2.2007)


Essential Requirements Check List

MHLW Notification No.122/2005(Heisei 17)✔Yakushoku Kihatsu No.0331012「Check List regarding conformity of designated controlled medical devices」

✔Yakushoku Kihatsu No.0823004「Check List regarding conformity of designated controlled medical devices

Part 2」

✔Yakushoku Kihatsu No.1025001「Check List regarding conformity of designated controlled medical devices

Part 3」

✔Yakushoku Kihatsu No.0801001（August 1, 2006 issued )「Check List regarding conformity of designated controlled medical devices

Part 4」


Product certification flow under Product certification flow under third party certification schemethird party certification scheme

①Application

ⅠComplaint( in case if you have any against decision )

②Certification

④Follow Up Audit

TPCB

evaluation of product

MHLW

ApplicantMAH

Need License for MAH, Mfg. cannot be applicant

Control certified medical devices

・

Ⅲ.Notice（Action performed or not）

③ Report

Ⅱ.Corrective Action（if it is necessary )

Criteria of conformity certificationCriteria of conformity certification((Notification 112, 2005 )Notification 112, 2005 )

Purpose of use、performance、conform to JIS standard

Essential RequirementEssential Requirement（（Check list annex to above)Check list annex to above)

•Risk management, biocompatibility, labeling etc ( STED )

•Chapter 2 :transition period until March 31,2008

Better fulfill the requirement as soon as you can.

QMS Conformity Assessment QMS Conformity Assessment （（Ordinance Ordinance 169169））


MAH

TPCB

MHLW

Report

Apply

LicenseMAH

Contract

LicenseFRAH

Manufacturer

Apply

MAH : Marketing Approval Holder

FRAH : Foreign Restrictive Approval Holder

How to get PAL approval

PMDAProductlicense

MAH( local office)

Application procedure

Contract

contractQMS(GMP)

GQP,GVP

CertificateProduct


Procedure of Certification

Form 64(1) from MAH, 64(3) from FRAHApplication form for manufacture and sales of designated controlled medical devices （2 sets）

Attached Document（ＳＴＥＤ）（2 sets）

Form 67(1) from MAH, 67(3) from FRAHApplication form for QMS conformity assessment of designated controlled medical devices （2 sets）

FRAH=Foreign Restrictive Approval Holder

Applicant shall prepare following forms;


Requirement of Safety & EMCSafety : JIS T 0601-1:1999

part1: General requirement for safety= IEC60601-1 :1988 edition 2

+ Amendment 1:1993+ Amendment 2:1995

JIS T0601-1-2-xx, or IEC60601-1-2-xx( refer to essential requirement )

EMC : JIS T 0601-1-2:20022.Collateral standard :EMC requirements and tests= IEC60601-1-2:1993


QMS Compliance Auditby the third party certification body in connection with product certification applied by MAH shall be conducted by the registered auditor of the third party certification body at;

Conducting QMS audit is stipulated by the PAL Manufacturer of Designated Controlled Medical Device Class IIManufacturer of Designated in-vitro medicals for diagnosticsExternal Facilities (sterilization facilities) Design and Development Facilities if requiredPackaging, Labeling and Storage Facilities (mainly at MAH)

Above information is referred to Class II medical device with essential requirements only


QMS Compliance AuditTiming

After submitting of Product Certification Application (Form 64) and Compliance Audit Application (Form 67) by MAH in JapanAt Re-Certification for compliance to the new PAL and Partial Change of DevicesRenewal(5 years)Surveillance not exceed than 2.5 years ±6 monthsWhen certification body and applicant require if necessary ( relocation of manufacturer, change of manufacturing method etc. )


QMS PrincipalsProduct compliance to QMS (Management System, Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement)Initial audit must be performed on-site( MHLW Notice No. 1130005)Applicable MHLW Ordinance No. 169 of 2004, chapter 2 (article 5-64)= identical to ISO 13485:2003 with deviations i.e. Control of Document/Record, responsible engineering manager

Document audit acceptable if on site initial audit has been conducted by the other third party certification body pursuant to MHLW QMS ordinance 169, chapter 2. No difference of audit between manufacturer in Japan and outside of Japan


QMS Audit responsible organizations

PMDAApproval byMinister

Class IV (High Risk ControlledMedical Devices )

Japan: Prefecture Government

Overseas: PMDA

Approval byMinister

Class III (High Risk Controlled Medical Devices )

Japan: PrefectureGovernment

Overseas: PMDA

ApprovalClass II (Controlled Medical Devices)

TPCBCertificationClass II (Designated ControlledMedical Devices with essentialrequirements (396 products)

not necessaryRegistrationClass I (General Medical Devices)

PMDA: Pharmaceuticals and Medical Devices Agency


Document (1)required for conducting QMS compliance audit third party certification body

Application Form(67) for compliance audit for designated controlled medical devices together with Application Form (64) for product audit (both to be prepared by MAH in Japan)


Document (2) required as for attachment to application (to be prepared by MAH )

(1) Updated Quality Manual of Manufacturer (Definitely)(2) Organization Chart of Manufacturer(Definitely)(3) Information on Manufacturer, No of Employee related to product

responsible person, function, management responsibilities, contactaddress incl. tel. fax No.(Definitely)

(4) Outline of Manufacturer and Flow chart of Process (Provided by MAH)(5) Product file for the applied products (on site )(6) Certificate (ISO 13485 etc.) or Approval of Manufacturer(on site)(7) List of Product (on site)(8) Information of Outsourcing (on site)(9) ISO13485:2003 Audit Report(incl. report Non-conformity,

CA)(on site)(10) Floor Plan(on site)


QMS Audit for Re-CertificationIs required for those medicals devices approved and registered under old PAL to the new PAL for compliance with JIS. MAH have to re-certificate these medicals deviceswhich are now classified under Class II applicable essential requirements, are subject to re-certificate by the third party certification body by latest March 31, 2008. Certification procedureis same as for certification the new medical devices Class II. Details will be instructed by MAH. Foreign Manufacturer is subject to QMS audit definitely.


QMS audit flow

1. Scheduling of audit2. Notice of audit and submitting audit plan3. On site audit (min. 2 man days)4. Audit result report at closing meeting5. Report of improvement action (plan)6. Confirmation of improvement action by the assigned

auditor7. Audit report by the auditor(s) to judgment committee


Major Nonconformities( among others by our experiences)

MHLW QMS Ordinance169 are not well informed by MAHQuality manual is not adapted to QMS Ordinance 169Retention time for documents and records are not pursuant to Ordinance 169 (deviation to ISO 13485:2003)Responsible Engineering Manager fails sometime(ISO 13485:2003= Management representative)Responsible Engineering Manager is for quality management system of productManagement representative is for quality management system throughout the organizationAgreement between Manufacturer and MAH is missing often


Nanotec Spindler Co. Ltd. cooperates with Intertek Group worldwide.Assigned Intertek Auditors are registered at MHLW as NanotecSpindler’s QMS Auditor.Please ask Intertek further detail and Intertek will help you.Please contact Intertek if you want essential requirement list. Essential requirements are however in Japanese.

QMS Audit


Time Frame for Certification

About 2 months after submitting application with all required documents by MAHTime Frame however depends on the time of on-site auditQuick response for corrective actions, improvement is required by the manufacturer after findings by the auditor(s).


Cost PerformanceCertification cost is settled by;

Case A: covered by MAHCase B: covered by the manufacturer

Quotation for MAH is consisting of;

Product AssessmentQMS audit - Manufacturer ( Manufacturing, Sterilization)

- Labeling, Packaging & Storage


URL:http//www.nanotecspindler.comContact :[email protected]

ご清聴ありがとうございました。

Thank you very much for your attention ！

謝謝大家！

Vielen Dank für Ihre Aufmerksamkeit !

Vele dank voor uw aandacht !Merci beaucoup !

Grazie perl’ attenzione !

Thank you for attending our webinar - · PDF fileThank you for attending our webinar ... Safety : JIS T 0601-1:1999 part1: General requirement for safety = IEC60601-1 :1988 edition

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