On August 31st, 2018, State Administration for Market Regulation (SAMR) issued ‘Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation’ implemented from January 1st, 2019. Monitoring adverse events is one of the most essential measures for inspecting medical devices on post-market stage. The measures regulate the obligations of overseas and domestic medical device Marketing Authorization Holders (MAH) and the requirements of relevant reports.
The requirements of medical device MAH:
-The ability to ensure safety and effectiveness of medical devices
-Building monitoring system for medical device adverse events
-Reporting medical device adverse events directly to monitoring technology institutes
The obligations of medical device MAH:
-Building Quality Management System for adverse event monitoring and re-evaluation
-Equipping fitting institutes and staff
-Collecting and reporting adverse events in regulated time to monitoring institutes
-The investigation, analysis, and evaluation for adverse events with State Drug Administration and controlling risk in time
-Writing regular risk evaluation reports
-Implementing medical device re-evaluation
Overseas MAH also obligate to communicate with China Authorized Representative (CAR) in time for interflow of the information about adverse events and re-evaluation.
CAR is the only representative authorized by overseas medical device MAH to deal with regulatory affairs. Monitoring adverse events and re-evaluation are two of the responsibilities for CAR. The administrative measures regulate the detailed requirements and obligations for CAR. CAR is supposed to prepare relevant systems regarding the measures and inform the measures to distributors and overseas medical device MAH.
After National Medical Products Administration (NMPA) issued the regulation for imported medical device CAR on August 3rd, 2018, NMPA and SAMR are gradually clarifying the details about CAR requirements and obligations. These measures are about adverse events and re-evaluation. CAR should work following relevant regulations and prepare for further standardized regulations.