China Issues New Adverse Event Requirements

The Chinese State Administration of Food and Drug (SFDA) recently issued a Tentative Guidance for the Monitoring of Adverse Device Events. The document outlines how manufacturers, distributors, and suppliers of medical devices should report and monitor adverse events.

The new guidance establishes timeframes for adverse event reporting. Notification for mass medical device emergencies must be submitted within 24 hours, case reports for suspicious deaths submitted within 5 working days, and cases involving serious injury that may lead to death must be reported within 15 days. After reporting the incident, manufacturers should conduct an internal investigation and submit a report within 20 working days. Reporting of all events, regardless of the class of medical device, should include SFDA’s “Medical Device Adverse Event Reporting Form.”

Annual summary reports of the previous year’s medical device adverse events are also required. Manufacturers of class 2 and 3 medical devices must submit their summary reports for the previous year by the end of January. They must also fill out and submit the “Annual Summary Medical Device Adverse Event Reporting Form.” Manufacturers of class 1 medical devices are not required to submit annual reports or forms, but they need to keep copies of annual summary reports of adverse event monitoring in their records.

Class 3 implants must provide an adverse event reporting system in Chinese for users, and the information must be indicated clearly in the Directions for Use.

Device manufacturers will also be required to establish central monitoring systems that include a product tracing system, as well as formal archives to record and monitor adverse events. On the personnel side, manufacturers will be required to train staff to monitor and report adverse events. The Guidance also requires device manufacturers to create internal standard operating procedures for mass medical device adverse event reporting, detecting, investigating, and evaluating.