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2026 China NMPA Bluebook is here:
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 Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155 Class III, 505 Class II and 143
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
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
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,
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
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
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
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