Analyze Future

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.

 

Portland, OR -- (ReleaseWire) -- 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.

Get full information of report at: http://www.analyzefuture.com/medical-device-gmp-regulations-in-chinese-market

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)

Browse similar reports at Analyze Future-

Global Wearable Medical Devices (Home Healthcare) Market- http://www.analyzefuture.com/wearable-medical-devices-market

Medical Dressing Market in Ukraine- http://www.analyzefuture.com/medical-dressing-in-ukraine-market

Surgical Equipment Market- http://www.analyzefuture.com/surgical-equipment-market

Medical Dressing Market in Netherlands- http://www.analyzefuture.com/medical-dressing-in-netherlands-market

Neurovascular Market- http://www.analyzefuture.com/neurovascular-market

About Analyze Future
Analyze Future bring to you research reports that will help you take an informed and strategic oriented decisions. Our sourced research reports are highly authentic and integrate latest market development for a better understanding. We have a repository of large market research reports helping with different needs.

We have research reports for numerous sectors and this is one place where you can find answers to your market research queries.

We have tie up with repute market publisher who provide high quality and precise reports. You can rely on such information and definitely find it relevant. We have a very efficient team who understands your queries and answers them promptly. They are well versed with all the market updated and latest trends and can guide you with purchase of reports.

Analyze future sells your most ethical and integrated market research reports at best price.

Contact:
Sona Padman,
5320 SW Macadam Avenue,
Suite 100,
Portland, OR 97239,
United States.
Direct: +1 (617) 674-4143
Toll Free: +1 (855) 711-1555
Fax: +1 (855) 550-5975
Email: sales@analyzefuture.com
Web: http://www.analyzefuture.com