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2026 China NMPA Bluebook is here:
NMPA published six guidelines in August 2021: Guideline for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework Guideline for Nomenclature
NMPA granted ten special statuses in August 2021, among them are seven innovation cardio devices: Boston Scientific Corporation: Vascular Plaque Atherectomy System TriReme Medical: Paclitaxel
The last time the “Medical Device Registration Administrative Measures” were completely overhauled was in 2014. The newer regulations with significant changes have been introduced focusing
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device LLC, your
The NMPA granted four fast-track statuses in July 2021, among them are two cardio devices: Innovation status Corindus: Coronary Artery Surgery Control System Shenyang Pengyue: Cardiac Cryoablation
The NMPA issued the second draft “Regulations on Self-test of Medical Device Registration (Draft)” on July 23, 2021, proposing further guidance to manufacturers on how
The State Administration for Market Regulation (SAMR) issued the “Measures for the Supervision and Administration of Cosmetics Production and Operation” on August 2, 2021. The
Manufacturers have long been concerned that when applying for drug-device combination product registration, in addition to original country approval for the combination product, the submission
The NMPA issued eleven Innovation Evaluation Reports for the 2nd Quarter of 2021, guiding overseas and domestic manufacturers on how to go through the fast-track
NMPA issued the final version of “2021 Medical Device Industry Standards Revisions Plan” on July 8, in which 77 medical devices and IVDs are affected.
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and
Our monthly NMPA News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVD in China, for the month