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2026 China NMPA Bluebook is here:
On May 16, 2023, the NMPA granted innovation approval to Corindus Inc., for its interventional coronary surgical control system accessories. It is the fifth imported
The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including
There have been 32 innovation approvals granted by the NMPA in 2022. Overseas manufacturer Medtronic, Ethicon and BioFire Diagnostics are on the list. Cardiovascular, gastro/urology,
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 Innovation Approvals to the following devices in July 2022: Cardiovascular Transcatheter prosthetic pulmonary valve system Implantable left ventricular assist system Radiology Gamma
The NMPA published “Implementation Plan for Supporting Hong Kong and Macao Drug Market Authorization Holders to Produce Drugs and Medical Devices in 9 Mainland Cities
The NMPA released the “Communication Standards for Innovation Approval and Priority Review” on December 1, effective from the date of publication. The standards are to
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 granted Innovation Approval to four medical devices in the first week of November 2021: Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit Zhuo Ruan
The NMPA granted Innovation Approval to three medical devices in September 2021: Dental implant surgery navigation and positioning equipment Ultrasonic diagnostic equipment for endoscope Transcatheter
Guangdong government published three documents on July 19, 2021 for feedback: Key Points for Application Materials for Import and Use of Hong Kong and Macau
NMPA granted nine manufacturers innovation approval and priority review status, including four overseas ones. The List Oncology Mevion Medical Systems: Proton Therapy System Biosense Webster