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Latest Guide to Chinese Medical Device GMP Regulations - Analyze Future

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.

 
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Portland, OR -- (SBWIRE) -- 06/05/2014 -- 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 2010, total value of medical devices on Chinese healthcare market has reached 120 billion RMB.

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To enter the Chinese lucrative medical device market, the first obstacle faced by overseas medical device manufacturers and producers is how to comply with the Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices. Lack of knowledge of the Chinese laws and administrative regulations, and the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas medical device manufacturers and producers. Therefore, a comprehensive and thorough knowledge of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices has been become an essential prerequisite for overseas medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, so more and more overseas medical device companies and multinational medical device companies, and their senior executive officers engaging in regulatory affairs expect to understand the latest 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.

Table Of Contents:

Chapter 1 Introduction

Chapter 2 Chinese Regulatory Authorities for Medical Device GMP Regulations
Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device GMP Regulations

Chapter 3 An Overview of Good Manufacturing Practice (GMP) for Medical Devices
3.1. General Provisions
3.2. Glossary
3.3. Management Responsibilities
3.4. Management of Resources
3.5. Documents and Records

Chapter 4 Inspection of Good Manufacturing Practice (GMP) for Medical Devices
4.1. Regulatory Authorities for Medical Device GMP Inspection
4.2. Application and Material Review
4.3. On-site Inspection
4.4. Inspection Conclusion
4.5. Supervision for Inspection
4.6. Management for Inspectors

Chapter 5 Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices
5.1. Implementation Guidelines of Good Manufacturing Practice (GMP) for Sterile Medical Devices
5.1.1. General Provisions
5.1.2. Glossary
5.1.3. Management Responsibilities
5.2. Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices
5.2.1. Inspection Method
Table 5.2.1. Form of Inspection Results Evaluation for Sterile Medical Device GMP
5.2.2. Inspection Items and Inspection Contents
Table 5.2.2.Form of Inspection Items and Inspection Contents for Sterile Medical Device GMP
5.3. Appendix: Setting Principles of Sterile Medical Device Production Clean Room (Area)
Table 5.3. Air Cleanliness Level of Clean Rooms (Areas)

Chapter 6 Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices
6.1. Implementation Guidelines of Good Manufacturing Practice (GMP) for Implantable Medical Devices
6.1.1. General Provisions
6.1.2. Glossary
6.1.3. Management Responsibilities
6.1.4.Management of Resources
6.2. Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices
6.2.1. Inspection Method
Table 6.2.1.Form of Inspection Results Evaluation for Implantable Medical Device GMP
6.2.2. Inspection Items and Inspection Contents
Table 6.2.2. Form of Inspection Items and Inspection Contents for Implantable Medical Device GMP
6.3. Appendix: Setting Principles of Sterile Implantable Medical Device Production Clean Room (Area)
Table 6.3 . Air Cleanliness Level of Clean Rooms (Areas)

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