Presently, the biochemical diagnosis industry is facing fierce competitions in the price, policies, and development models.

In 2023, a total of 12,213 first registrations, renewals of registrations and changes of registrations of medical devices were approved by NMPA, representing an increase of 2.3% in the total number of registration approvals compared with 2022.

From 1 January to 31 December 2023, China’s NMPA accepted a total of 13,260 applications for the first registration, renewal of registration and change of registration of medical devices in accordance with its duties, an increase of 25.4% compared with 2022.

In 2023, China Chamber of Commerce of Medical & Health Products Importers & Exporters (CCCMHPIE) successively announced three batches of export brand certificates for companies recommended by CCCMHPIE in FY2023.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

As of the end of June 2023, the number of valid registrations and filings of medical devices nationwide reached 301,639, an increase of 18.12% compared with the same period of last year, with 46,283 new cases, an increase of 7.25% compared with the end of 2022 (281,243 cases).

On 5 July 2023, National Medical Products Administration announced the imported Class I medical device product in June 2023. A total of 145 product information, including 7 products in the IVD industry, were finally released.