In order to support the supply of antigen testing reagents for COVID-19, the Chinese authority NMPA announced the following:

1. 1. The validity of the registered and approved antigen testing reagents for COVID-19 will be extended by 6 months on the basis of the original validity.
2. 2. The registrant of the antigen testing reagent for COVID-19 shall fully implement the <Regulation on the Supervision and Administration of Medical Devices (医疗器械监督管理条例)> and its supporting regulations. The responsibilities of quality and safety shall be fulfilled, and the post-market research shall be strengthened.  Moreover, the requirements should be achieved before the expiry of the original registration and the renewal application shall be submitted in time.
3. 3. Each provincial medical products administrations shall strengthen the post-market surveillance of the antigen testing reagent for COVID-19 in order to ensure the quality and safety of the products.

 

Reference:
● Announcement of the NMPA on extending the validity period of the registration certificate of the COVID-19 antigen testing reagent (2022 No. 114)