NMPA Issued the Announcement on the Guidance for Medical Device Registrants to Conduct Adverse Events Monitoring
To implement the requirements of theProvisions for the Monitoring and Reevaluation of Medical Device Adverse Events (SAMR and NHC Order No.1), guide and regulate medical device registrants and applicants for record filing (hereinafter collectively referred to as registrants) to perform adverse events monitoring, NMPA has organized the formulation of and released on April 10, 2020 the Guidance for Medical Device Registrants to Conduct Adverse Events Monitoring.
The Guidance for Monitoring Medical Device Adverse Events (Interim) (CFDA [2011] No. 425) issued by the former State Food and Drug Administration shall be repealed simultaneously.
