CMD Blogs

NMPA CMDE (Center for Medical Device Evaluation) published Evaluation Reports for 23 innovative devices in 2019, aiding manufacturers on the vital points to obtain market

NMPA published Registration Guideline on Novel Coronavirus Nucleic Acid Detection Reagent today (Jan 12), addressing the urgent needs of virus diagnostics. Accelerated Approval After issue

NMPA announced seven recalls in January 2020: Johnson & Johnson: Contact lens Philips Medical Systems: Medical angiography X-ray system Medtronic: Drug infusion system GE: Anesthesia

China has accelerated the Emergency Approvals under the threat of Novel Coronavirus (“2019-nCoV”). National NMPA granted seven Emergency Approvals to Coronavirus Nucleic Acid Detection Reagent

NMPA published the Technical Guidelines on Medical Device Clinical Evaluation (draft) on January 2, 2020 for feedback. The draft Guidelines consist of three documents: Clinical

NMPA published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. Please

From regulatory submission to approval, it only took 2 days for a coronavirus nucleic acid detection kit to go to market. On January 28, Jiangsu

NMPA (CFDA) published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. The

China national NMPA informed local NMPAs on Monday Jan 27 to allow import none -NMPA approval devices but have FDA approval, CE mark, or Japan

NMPA published the “Medical Device Submission Document Administrative Measures during the Supplement Phase” (final) on January 16, 2020. NMPA issued the draft version on November

NMPA granted Innovative Device Approval to nucleic acid amplification detection analyzer, manufactured by Hangzhou Yousida, on December 30, 2019. This product is based on the