Do Class III medical devices need to provide safety assessment reports?

Class III medical devices need to provide safety assessment reports. According to relevant websites, the National Adverse Drug Reaction Monitoring Center explained the time and data summary scope of writing and submitting the periodic risk assessment report for medical devices for the first time according to the Administrative Measures for Monitoring and Re-evaluation of Adverse Medical Device Events, and the registrants of Class II and Class III medical devices should submit the annual periodic risk assessment report according to the requirements of the Measures.