Current Situation and Updates of QMS

Inspection in Japan

Office of GMP/QMS InspectionPharmaceuticals and

Medical Devices Agency

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Framework of Approval Review and QMS Inspection on Medical Device

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Application Form

ApprovalApplication

Form

Review Divisions 軽微変更届出

Design transfer to manufacturing site

Approval

Minor ChangeNotification

1) Acceptance2) Confirmation

at regularinspection

QMS inspectionbefore approval

Partial ChangeApplication

1) Review2) QMS inspection

Actual production

QMS inspection every 5 years after approval

Pre-approval Post-approval

Product realization,Measurement,Analysis of data,Improvement

Types of QMS Inspection

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Compliance inspection

1 Pre-approval inspection 2 Post-approval inspection

(periodic inspection)

For-cause inspection

Authority of GMP/QMS Inspection

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Site Location Domestic Foreign

IVDs

・New drugs・Radioactive drugs PMDA PMDA

Products without CS* Prefectures PMDA

Products with CS* Registeredcertification body

Registeredcertification body

Medical Devices

・New medical devices・Cell / Tissue-based

medical devices・Class Ⅳ products

PMDA PMDA

Class Ⅲ and Class Ⅱproducts (without CS*) Prefectures PMDAClass Ⅱ products(with CS*)

Registeredcertification body

Registeredcertification body

*CS : Certification Standards

Compliance Inspection by PMDA

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* New medical devices are, as a rule, limited to ones that have new principle or new functional characteristics.

Target Products Target Sites1. New medical devices*2. Cell-tissue-based

medical devices3. Class IV medical devices4. Radioactive IVDs

1. Manufacturing Sites2. Sterilization Facilities3. Storage Facilities4. Testing Laboratories5. Design and

development institutes

On-site Inspection and Document Review

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Complexity of manufacturing processes

Risk associated with the use of products

Results of the previous on-site inspections

Previous nonconformity, recall, or the contents

On-Site Inspection Document Review

Principle of QMS On-site Inspection and Document Review (Concrete Example)

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Facility A

1st application of QMS inspection （Product “a”） 2nd application

（Product “b”）3rd application（Product “c”)

4th application（Product “d”）

On-site inspection

On-site inspectionDocument

review ※Document review ※

2 years＊ （time after the 1st notification of QMS compliance result）※ Document review is confined to the facility not having

experienced Class-1 recalls and field corrections.Major manufacturer concerned with the product for marketing

approval application ※※

※※ Major manufacturer of the product : Facility A is supposed.

Manufacturing sites concerned with the product for marketing approval application(Example)

Assembling

Contract Sterilization

Packaging, Labeling or Storage

Packaging, Labeling or Storage（domestic）

Facility A

Facility A’ (backup of Facility A)

Facility B

Facility C

Facility D

On-site inspection

On-site inspection

Document review

Document review

Document review

a: PTCA Catheter b: Pacemaker c: Stent d: Defibrillator

Relation between MHLW MinisterialOrdinance #169 and ISO13485:2003

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MHLWOffice Memorandum

May 30, 2011

Q & A regarding the relation between Ministerial Ordinance #169 and ISO13485:2003

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Relation between MHLW MinisterialOrdinance #169 and ISO13485:2003

MHLW Ministerial

Ordinance #169ISO13485:2003

Additional Requirements

(almost) Equal Requirements

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Contents of MHLW Ministerial Ordinance #169(QMS Ordinance)

Chapter 1 General Provisions

Chapter 2 Medical Devices

Manufacturers, etc.Chapter 4

Biological-origin Medical Device, etc. Manufacturers,

etc.

Chapter 3 Labeling, etc. – Category

Medical Devices Manufacturers, etc.

*Chapter 5 : In-Vitro Diagnostics Reagents Manufacturers, etc.(The provisions of Chapter 2 and 3 shall be applied Mutatis Mutandis.)

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Relation between MHLW MinisterialOrdinance #169 and ISO13485:2003

Min

iste

rial

Ord

inan

ce #

169

Req

uire

men

ts

ISO13485:2003Requirements

#169

Cha

pter

2 R

equi

rem

ents

Additional Requirements

#169 Chapter 3Requirements

#169Chapter 4

Requirements

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Additional Requirements

Retention period of obsolete controlled documents and records

Written procedure of training

Additional Requirements regarding infrastructure

#169

Cha

pter

2A

dditi

onal

Req

uire

men

ts

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Check!! MHLW Ministerial Ordinance #169

http://www.pmda.go.jp/english/service/ministerial.html

Available PDF File:Ministerial Ordinance #169

More information about details of PMDA’s QMS Inspection

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http://www.pmda.go.jp/english/service/qms.html

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Thank you very muchfor your kind attention!!