China Issues Raft Of Regulatory Notices: Guidelines, Standards And More Reforms

The January 2019 Asian Medtech Associations Regulatory Networking discussions focus on the volume of activity within China’s agencies in issuing guidances, technical standards, and in review updates. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Flags of China flying in Shanghai

The past two months have seen the Chinese government issue many updates for the medical technology industry, in both summaries of technical guidance and China unique standards; and in changes to the medical device review process.

These high-level updates include the National Medical Products Administration’s (NMPA, formerly the CFDA) release of four registration technical review guidelines;...

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