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2026 China NMPA Bluebook is here:
NMPA (CFDA) approved the ‘human 10 gene mutation combined detection kit’, manufactured by Amoy Diagnostics, the first of its kind in the CDx (companion diagnostic)
NMPA (CFDA) issued the final version of “2019 Medical Device Industry Standards Revision Plan” yesterday (March 20), in which 93 medical devices, IVDs are affected.
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited
Collaborate with AdvaMed, we present: How to Navigate Type Testing in China Webinar March 20, 2019 | 10:30 – 11:30 am EST Register Here China
NMPA (CFDA) published the latest batch of overseas inspection results on March 5. Seven overseas medical device and IVD manufacturers were cited:Medtronic, Bausch & Lomb,
On March 1st, 2019, Grace Palma, CEO of China Med Device, is interviewed by BioWorld MedTech about the revised registration guidelines for medical devices. With revised
NMPA (CFDA) clinical trial requirements have been significantly strengthened over the years. In 2016, 8 out of 20 clinical trials have been identified with issues
NMPA announced the “2019 Medical Device Registration Guidelines Revision Plan” today (February 25), in which 86 medical devices, IVDs and documentation methods are included. The
Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by
NMPA (CFDA) published two groups of overseas inspection results on Jan 18 and Jan 30. 17 overseas medical device and IVD manufacturers were cited, including
NORTH ANDOVER, Mass. – January 31, 2019 – ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China,
Do you need assistance in NMPA (CFDA) consultation before initiating your registration? In the areas where it is not clearly defined, it is better to