To implement the related requirements of the Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation (Order No. 1 of the State Administration for Market Regulation and the National Health Commission) and standardize and guide medical device registrants to conduct post-marketing risk evaluations of medical devices, the National Medical Products Administration has organized the formulation of the Guidelines for Medical Device Registrants to Conduct Adverse Event Risk Evaluations of Products and hereby issues it.
Attachment: Guidelines for Medical Device Registrants to Conduct Adverse Event Risk Evaluations of Products
Attachment: Guidelines for Medical Device Registrants to Conduct Adverse Event Risk Evaluations of Products
National Medical Products Administration
November 25, 2020
November 25, 2020