Guidelines for Reporting Adverse Events

On November 27, 2020, the National Medical Products Administration (NMPA) issued (No.78 – 2020) the guideline for the standard procedure that NMPA Legal Agents shall follow when submitting risk evaluation reports after an adverse event.

In general, the medical device registrants or filing persons are responsible to verify the investigation results of the adverse event, analyse the data collected from post-market surveillance and other risk reports, arrange product inspections, prepare the analysis, evaluation, and control of risks.

According to the guidelines, the medical device registrants or filing persons are advised to investigate, analyse and evaluate the occurrence of the adverse event within a short turnaround time. The medical device registrant or filing person should be prepared to carry out a risk evaluation report if any unreasonable risks of the product are identified, which could be required by the respective MPA or self-initiated by the medical device registrant or filing person.

If the medical device registrants is requested by a government official to submit the risk evaluation report, it should always be submitted directly to the National Center for ADR (Adverse Drug Reaction) Monitoring in China. Otherwise, if the risk evaluation work is self-initiated by the medical device registrant or filing person, the report should only be submitted to the local MPA, and the local MPA should forward the report to the National Center for ADR Monitoring.

By Jacky Li. Contact Cisema if you would like to learn more.