What is a suspicious medical device adverse event?

Adverse events of medical devices refer to any harmful events that have occurred or may occur under normal use of medical devices that have been approved for marketing and passed the inspection, and have nothing to do with the expected use effect of medical devices. Suspected medical device adverse events refer to suspected but undiagnosed events.

Medical device manufacturing enterprises and operating enterprises shall report medical device adverse events that have caused or may cause serious injury or death to the products they produce and operate.

The user of medical devices shall report the medical device adverse events that have caused or may cause serious injury or death to the medical devices used by the user.

Reporting medical device adverse events should follow the principle of suspicious reporting.