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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...