In order to support the supply of antigen testing reagents for COVID-19, the Chinese authority NMPA announced the following:
- 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. 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. 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.
● Announcement of the NMPA on extending the validity period of the registration certificate of the COVID-19 antigen testing reagent (2022 No. 114)