In this week’s roundup: China’s National Medical Products Administration issues regulatory documents for implementing recent reforms and guidance documents on nanotechnology, artificial ligaments, and other topics. Also, a new Medicare Coverage of Innovative Technology proposal is under administrative review, FDA launched a 510(k) submissions tracker, and more.
Developments at China’s NMPA:
(All linked documents are in Simplified Chinese)
China reg measures. The National Medical Products Administration issued new “administrative measures” for its medical device and IVD registration and filing rules on August 31. The measures, which will take effect October 1, are largely intended to help implement overall reforms to NMPA’s device/IVD regulations that went forward this summer. (See “New Chinese Medtech Regs Offer New Opportunities,” Market Pathways, August 4, 2021.) The measures address details related to evolving approaches in China to clinical trial exemptions, foreign certification requirements, inspection regimes, and an array of other issues.