IEC

CE

CE (中文版）

FDA

Regulation in China: CCC (中国强制认证)

European: medical devices Directives

WEEE: waste electrical and electronic equipment

Regulation in UK

BS 英国标准协会标准

NF 法国标准

DIN EN 德国及欧州标准

IEC 国际电工委员会标准

CECC 欧洲电子元器件协会标准

VDI 德国工程师协会标准

ETSI 欧洲电信标准

MEDICAL DEVICE REGULATIONS -- Global overview and guiding principles

WORLD HEALTH ORGANIZATION

Foreword v
Glossary vii
Note on the definition of medical devices vii
Chapter 1. Introduction 1
Chapter 2. Medical device safety 3
2.1 Medical device safety and risk management 3
2.2 Effectiveness/performance of medical devices 4
2.3 Phases in the life span of a medical device 5
2.4 Participants in ensuring the safety of medical devices 6
2.5 The role of each participant/stakeholder 7
2.6 Shared responsibility for medical device safety and performance 8
Chapter 3. Governmental regulation of medical devices 9
3.1 Critical elements for regulatory attention 9
3.2 Stages of regulatory control 10
3.3 A common framework for medical device regulations 10
3.4 Regulatory tools and general requirements 11
3.4.1 Product control 11
3.4.2 Vendor establishment control 12
3.4.3 Post-market surveillance/vigilance 12
3.4.4 Quality system requirements 13
Chapter 4. Global Harmonization Task Force (GHTF) 15
4.1 Objectives 15
4.2 Scope of the four GHTF study groups 15
4.3 Benefits of the GHTF 16
4.4 Final documents from the GHTF 17
4.5 Global Medical Device Nomenclature (GMDN) 17
Chapter 5. Standards 18
5.1 What are standards? 18
5.2 Why do we need standards? 19
5.3 Voluntary and mandatory standards 19
5.4 Standards development process 20
5.5 Conformity assessment with standards 20
5.6 National and international standards systems 21
5.7 Identification of standards 21
5.8 Current trends in the use of standards in medical device regulations 22
Chapter 6. Optimizing the use of regulatory resources 24
6.1 Increasing knowledge of the medical device sector 24
iv
MEDICAL DEVICE REGULATIONS
6.2 Establishing basic regulatory programmes 25
6.2.1 Basic legislation 25
6.2.2 Sharing problem reports 25
6.3 Drafting a comprehensive policy or guideline on medical device
management 26
6.3.1 Advantages of a national policy 26
6.3.2 Classification of medical devices 26
6.3.3 Medical device product control 27
6.3.4 Product representation control 27
6.3.5 Vendor establishment control 28
6.3.6 The control of home-use, refurbished, and donated devices 28
6.3.7 The re-use of medical devices that are labelled “for single use”29
6.3.8 Post-market surveillance 30
6.3.9 Recognition and use of established national or
international standards 31
6.4 Promoting compliance and cooperation 31
6.5 Setting priorities for regulatory programme development 32
6.6 Cautions in interpreting medical device “export certificates” 34
Chapter 7. Priorities on the international agenda 36
Annex 1. Resources for medical device information 37
Annex 2. Final documents of the GHTF as they relate to the Common
Regulatory Framework 40
Annex 3. Relationship between ISO9001:1994 and ISO13485:1996 41
Annex 4. Aide-mémoire for National Medical Device Administrations 42