Hexa Reports

Market Research Reports and Insightful Company Profiles

Latest Guide to Chinese Medical Device GMP Regulations

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.
Browse Detail Report With TOC @ http://www.hexareports.com/report/latest-guide-to-chinesemedical-device-gmp-regulations/details
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

Hexa Reports
Market Research Reports and Insightful Company Profiles
Request A Sample copy of This Report @ http://www.hexareports.com/sample/50875
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
Browse Full Report @ www.hexareports.com/report/latest-guide-to-chinese-medical-device-gmpregulations/details
About Us:
Hexa Reports is a market research and consulting organization, offering industry reports, custom
research and consulting services to a host of key industries across the globe. We offer comprehensive
business intelligence in the form of industry reports which help our clients obtain clarity about their
business environment and enable them to undertake strategic growth initiatives.

Hexa Reports
Market Research Reports and Insightful Company Profiles
Contact Information:
Ryan Shaw
Felton Office Plaza,
6265 Highway 9,
Felton, California, 95018,
United States
Phone Number
1-800-489-3075
Email Us: sales@hexareports.com
Our Website: http://www.hexareports.com/