July 3, 2019
NMPA (CFDA) Final Guideline on AI-Aided Software: Propels China to the Leadership of AI Applications
NMPA (CFDA) issued the Technical Guideline on AI-Aided Software on June 28, 2019. After the draft version issued on February 1, nearly five months of efforts have been made to classify the vital evaluation points […]
June 27, 2019
In 2019, NMPA (CFDA) has announced 3 batches of Overseas Inspection Results. A total of 24 foreign manufacturers, including Medtronic, Becton Dickinson, Boston Scientific, B.Brown, Bausch & Lomb and Varian, […]
June 25, 2019
ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped a medical device company to get clinical trial and NMPA […]
June 21, 2019
NMPA (CFDA) published 2018 Medical Device Registration Report on May 31. ChinaMed Device compiled the data and made four charts to illustrate the current trend for imported devices in China. […]
June 19, 2019
The NMPA (CFDA) Newsletter covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a […]