Doing Business in China

Research on Chinese Good Manufacturing Practice Regulations for Medical Devices

As the world's largest population, prospects for medical device spending in China is huge. Government healthcare reforms are a major driving force behind China's healthcare sector. Not only are these policies instrumental for improving the healthcare system in China, but they also create significant market opportunities for companies in the lucrative Chinese medical devices market. The medical device market in China was valued at 120 billion RMB in 2010 and is estimated to surpass 600 billion RMB within the next few years. At this pace, China is expected to supplant Japan as the world's second largest medical device market behind the United States. Foreign and overseas medical device manufacturers and producers will increasingly seek opportunities in China, to penetrate this fast-growing market. The question is can potential market entrants overcome the barriers?

The first obstacle for medical device manufacturers and producers is how to comply with the Chinese Good Manufacturing Practice (GMP) Regulations for medical devices. Knowledge about Chinese laws and administrative regulations and understanding of cultural differences are imperative. An essential resource for medical device manufacturers and producers to achieve successful entry into the Chinese medical device market, the "Latest Guide to Chinese Medical Device GMP Regulations" provides a detailed guidance of comprehensive and thorough knowledge of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices.

Highlights from the guidebook include:

  • An overview of medical device GMP
  • Details of inspection regulations, implementation guidelines, and inspection criteria for both sterile and implantable medical devices, and
  • A complete set of English and Chinese bilingual application and inspection forms of Good Medical Device Manufacturing Practice.

Learn more about the guidebook and request free sample pages at here.

No more results found.
No more results found.