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2024 China NMPA Bluebook is here:
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
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 Medical Devices by Designated Institutions
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 to self-test and to submit
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 regulatory submission. It is the
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