To implement the requirements of Provisions for the Monitoring and Reevaluation of Medical Device Adverse Events (SAMR NHC Order No. 1), guide and regulate the adverse event monitoring of medical devices registrants and filing applicants (hereinafter referred to as the registrants), the National Medical Products Administration has organized the formulation of and released the Guidance for Medical Device Registrants to Conduct Adverse Events Monitoring.

The Guidance for Medical Device Registrants to Conduct Adverse Events Monitoring (Interim) (CFDA [2011] No. 425) issued by the former China Foods and Drugs Administration shall be repealed simultaneously.

It is hereby announced.

Annex: Guidance for Medical Device Registrants to Conduct Adverse Events Monitoring

National Medical Products Administration

April 3, 2020

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