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2025 China NMPA Bluebook is here:
The NMPA issued the “Clinical Pathway Recommendations for Certain Active and Passive Implantable Devices” on April 6, 2022. The document suggests manufacturers how to choose predicate comparison or clinical trial
The NMPA and China Health Commission released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, implemented from May 1, 2022. The “China GCP” covers the whole process
Hainan Lecheng Boao International Medical Pilot District released “Pilot Trials of International Innovative Neurological Products” on March 29, 2022, to solicit imported products from neurological device manufacturers, research institutions and
The NMPA granted approvals to two devices, Boston Scientific’s Rezūm Water Vapor Therapy equipment, and its disposable prostate treatment accessory on March 3, 2022. It only took four months for
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 of Guangdong province: Guangzhou, Shenzhen, Zhuhai,
“Selection of Urgent Needed Drugs and Medical Devices for Insurance Application” was published by Hainan Boao Tourism Pilot Zone Administration on February 10, 2022. It asks foreign manufacturers to submit
If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical Evaluation of Medical Devices” published
The NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications. Significantly referred to many FDA guidance,
NMPA published the “Evaluation of the Safety and Effectiveness of Medical Devices Containing Nanomaterials Part I: Framework” on August 30, 2021, directing manufacturers on key issues of nanomaterials’ registration. The
The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting clinical trial. It states that,
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 equipment. Indication and composition
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021, finalizing the draft version issued in late November 2020. Clinical data generated outside