In June 2023, the State Food and Drug Administration approved a total of 264 registered medical device products. Among them, there are 198 domestic Class III medical device products, 46 imported Class III medical device products, 19 imported Class II medical device products, and 1 Hong Kong, Macao and Taiwan medical device product (see the attachment for specific products).

Guorui Zhongan screened the contents of the attachments and separately displayed the 26 in vitro diagnostic products approved for registration this time, as follows:

Judging from the companies on the list themselves, the companies that have recently obtained medical device registration certificates are basically well-known companies in the IVD industry; from the product itself, they are mainly Category III in vitro diagnostic kits; Category III devices do have The cost of certification is high and registration is difficult. The regulatory registration team of Guorui Zhongan Group can assist medical device companies in applying for NMPA registration of Class III medical devices (including in vitro diagnostics), domestic clinical trial research, registration and inspection submission, physical examination coaching and other one-stop CRO technical services!