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Dear colleagues,
a question concerning China and the registration of medical devices manufactured locally.
As you may know, last year the NMPA issued Announcement No. 104 [2020] which foresees a "simplified" registration pathway for medical devices and IVDs manufactured in China AND fully equivalent to a foreign product already registered and marketed in the Country. Basically, it's a sort of "manufacturing transfer".
Do any of you have had direct experience with the No.104 [2020] regulation so far? If so, would you recommend it and what would be the biggest watch-outs?
Thank you.