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2026 China NMPA Bluebook is here:
China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be
1 new guideline and 40 new industry standards have been released by CFDA from April 1st. Even though they are called guidelines, once they are released, you are
3 new guidelines have been released by CFDA from March 22rd to March 24th. Even though they are called guidelines, once they are released, you
7 new guidelines have been released by CFDA from March 13rd to March 17th. Even though they are called guidelines, once they are released,
China’s new requirements for CERs (Clinical Evaluation Reports) and CTs (Clinical Trials) have now been in place for more than two years. Understanding the difference
March 28-30, 2017 • Bethesda North Marriott • North Bethesda, MD The Annual Medical Device Quality Congress is going strong on their 14thyear. The conference
China is back from its >10 days national new year celebration. CFDA is busy releasing more guidelines now. Since February 10th, 2017, six have been
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
If you need to provide feedback to CFDA, please let us know and we will consolidate and send it for you. Please email to .
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
Next week is a long national holiday in China, celebrating the founding of People’s Republic of China in 1949. My inbox will slow down but