Latest Guide to Chinese Medical Device GMP Regulations is an essential resource for overseas medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, which provides a detailed guidance of comprehensive and thorough knowledge of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices.
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Summary China is one of the fastest growing global economies with a fourth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2012, total value of medical devices on Chinese healthcare market has reached 138 billion RMB.
Table Of Content
Chapter 1 Introduction.4
Chapter 2 Chinese
Regulatory Authorities for Medical Device GMP Regulations.8
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Chapter 3 An
Overview of Good Manufacturing Practice (GMP) for Medical Devices.10
3.1. General
Provisions.10
3.2. Glossary.10
3.3. Management
Responsibilities.12
3.4. Management of
Resources.12
3.5. Documents and
Records.13
Chapter 4
Inspection of Good Manufacturing Practice (GMP) for Medical Devices.23
4.1. Regulatory
Authorities for Medical Device GMP Inspection.23
4.2. Application
and Material Review.23
4.3. On-site
Inspection.25
4.4. Inspection
Conclusion.27
4.5. Supervision
for Inspection.28
Chapter 5
Implementation Guidelines and Inspection Criteria of Good Manufacturing
Practice (GMP) for Sterile Medical Devices.69
5.1. Implementation
Guidelines of Good Manufacturing Practice (GMP) for Sterile Medical Devices.69
5.2. Inspection
Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices.84
5.3. Appendix:
Setting Principles of Sterile Medical Device Production Clean Room (Area).138
Chapter 6
Implementation Guidelines and Inspection Criteria of Good Manufacturing
Practice (GMP) for Implantable Medical Devices.141
6.1. Implementation
Guidelines of Good Manufacturing Practice (GMP) for Implantable Medical
Devices.141
6.2. Inspection
Criteria of Good Manufacturing Practice (GMP) for Implantable Medical
Devices.160
6.3. Appendix:
Setting Principles of Sterile Implantable Medical Device Production Clean Room
(Area).211
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