NMPA Continues To Consolidate The Foundation Of Medical Device Registration Management

In 2021, NMPA continues to consolidate the foundation of medical device registration management, ensuring the medical device developing sound and health.

• Medical Device Standards

NMPA established two standard formulation organizations of medical device evaluation and medical high-throughput sequencing for more sound standard organizations; approved the revision plans of 79 industry standards and the issuance of 146 industry standards; evaluated 396 mandatary standards and another 62 under-research mandatory standards. Till the end of 2021, China has 1849 current effective medical device standards, of which 235 national standards, 1614 industry standards.

• Classification identification

In 2021, NMPA published the Working Procedures for Classification Catalogue Dynamic Adjustment, completed 1993 classification identifications; revised Class I Medical Device Catalogue; formulated IVD Classification Rules; set up the classification rules of recombinant collagen and artificial intelligence products; pushed forward the classification of aesthetic products, edge products and combo products; issued 9 naming guidelines to further lead the standardized naming of medical devices.

• UDI progress

In 2021, NMPA pushed forward the first batch of high-risk product UDI works; issued the second batch of UDI product. Till the end of 2021, there are 1.05 million UDI information in NMPA database.

• Two sub-center operating

NMPA CMDE Yangtze-River Delta center and Guangdong-Hongkong-Macao center are operation. As per BradyKnows experiences, these two sub-centers are executing the review works of renewals in the latest months with high efficiency and smooth communication channels.