On September 26, 2020, CMDE released an announcement of matters concerning the production of imported medical devices within the territory of China. The relevant matters applicable to the announcement are as follows: more…
On September 14, 2020, CMDE announced a notice to collect suggestions on 2021 medical device registration review work plan. This plan compilation includes a proposal on technical review guidelines for medical device registration more…
On September 8, 2020, CMDE announced its preparation of Technical Review Guideline on the Medical Device Cybersecurity (draft). This Guideline is the second version draft on the cybersecurity issues of the medical devices. more…
