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2026 China NMPA Bluebook is here:
The NMPA issued the “Guideline on Artificial Intelligence Medical Devices (Draft)” on June 4 for feedback. The document is to direct manufacturers on how define,
China Med Device, LLC joined the NMPA Session on interpreting the “Notice of Medical Device Submission Material Requirements and Certificate Format” held on December 16,
The NMPA released 19 industry standards on December 10, 2021, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The standards
The NMPA granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for
The NMPA issued a notice “Interpretation of Regulations on Self-test of Medical Device Registration” on October 27, 2021, explaining the self-test report guideline in details.
One giant leap from China medical device regulators—the NMPA began to recognize self-test report from manufacturers, with detailed guidebook on how to self-test. After two
The NMPA issued the Guideline for Medical Device Clinical Trial Data Submission Requirements (draft) on September 15, 2021 for feedback. The feedback needs to be
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities
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
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