Medical Devices

Latest Guide to Chinese Medical Device GMP Regulations

  • ACC793
  • 213 Pages
  • March 2013
  • Medical Devices

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.



In 2009, the Chinese government vigorously launched “China’s Health-Care Reform”, developed an ambitious blueprint, in which health care system has covered about 1.2 billion people by 2011. Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. It is estimated that within the next few years, Chinese medical device market will be likely to be more than 600 billion RMB, and will surpass Japan to become the second largest medical device market following the United States. The Chinese medical device market will attract more and more overseas medical device manufacturers and producers to penetrate such 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.



The Chinese regulatory authorities for medical devices, the State Food and Drug Administration(SFDA) issued the latest Medical Device GMP regulations inDecember 2009, including the Good Manufacturing Practice (GMP) for Medical Devices (Interim), the Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical Devices (Interim), the Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices(Interim), and the Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices (Interim), which all came into effect as of January 1, 2011.



The organizations of this guidebook are arranged as follows. Chapter 2 provides the organizational structure of Chinese regulatory authorities for medical device GMP regulations. Chapter 3 provides an overview of Good Manufacturing Practice (GMP) for Medical Devices, which are comprehensive regulations to regulate a manufacturer’s quality management system throughout the process ‐ from design, development and manufacturing to sales and after-sale service. Chapter 4 introduces the details of the Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical Devices. Chapter 5 introduces the Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices in detail. Chapter 6 provides the detailed comprehensive guidance of Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices.



 



The audiences of this guidebook are overseas medical device companies and multinational medical device companies wishing to enter into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand the latest Chinese Medical Device GMP regulations. After have skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Medical Device GMP regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their companies in China.



Guidebook Highlights




  •   An overview of Good Manufacturing Practice (GMP) for Medical Devices.

  •  The details of Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical Devices.

  • The Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices

  • The Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices

  • A full set of the English and Chinese bilingual application and inspection forms of Good Manufacturing Practice for Medical Devices.

  •  An overview of the entire application and inspection procedure for Medical Device GMP.

  • The comprehensive inspection items and inspection contents of GMP for Sterile Medical Device and Implantable Medical Device.



Who should buy this report?




  • Overseas medical device companies wishing to enter a lucrative drug market in China.

  • Overseas medical device companies interested in understanding the latest Chinese Medical Device GMP Regulations.  

  • Senior executive officers engaging in regulatory affairs expecting to understand the latest Chinese Medical Device GMP regulations.

  • Senior executive officers engaging in regulatory affairs for quality control, quality assurance, and production management for medical device manufacture.

  • Non-Chinese pharmaceutical consultative companies engaging in agentservice for application and inspection of Medical Device GMP with the Chinese government authorities.

  • Non-Chinese universities, colleges, academic & research institutions

  • Non-Chinese university library, public library.

  • Non-Chinese Chamber of Commerce.


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