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2026 China NMPA Bluebook is here:
In the previous column, we discussed China’s fast track approval process for innovative medical devices and how products can qualify under a new guideline issued
CFDA issued a new guideline for document preparation of innovative medical device special approval process on Dec. 15, 2016. The initial general decree that governs
I am sharing a response I posted to a question by a manufacturer RA. The Guideline was issued on Sept 21 for further feedback and
Since 2015, more than 100 regulations and laws have passed from the central government mandates to CFDA requirements biggest shakeup since 2000. The changes impact