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2026 China NMPA Bluebook is here:
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
On January 3, 2019, NMPA (CFDA) issued Medical Device Master Files Filing Process (draft) for feedback. Feedbacks need to be submitted by Feb 4, 2019.
NMPA (CFDA) announced “2019 Medical Device Industry Standard Revision Draft Plan” for public comments on December 11, 2018 to medical device/ IVD regulations in order
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) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important