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2026 China NMPA Bluebook is here:
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,
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 beam stereotactic radiation therapy system
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 in the Greater Bay Area
The NMPA Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155 Class III, 505 Class II and 143 Class I medical devices, and
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. The classification and definition of the following devices are affected: NMPA
With the rapid development of the industry and continuous emergence of new technologies, new materials and new products, the “Medical Device Classification Catalog”, effective from August 2018, is in the
The NMPA published the “Catalog of Medical Devices Prohibited from Contract Manufacturing” on March 24, 2022. Compared with the draft version, issued in November 2021, with 22 devices on the
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 direct manufacturers on what 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 equipment. Indication and composition
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 Medtech: Biological Hernia Repair Patch
Unlike the “Medical Device Classification Rules”, the NMPA did not separately regulate the classification of IVD reagents before. Instead, the guidelines were written into the “Notice on Issuing the Registration
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 aortic valve and retrievable delivery