What are the types of adverse events of medical device products, and how long is the time limit for reporting to the regulatory authorities?

Adverse medical device events refer to any harmful events that occur or may occur under normal use of qualified medical devices approved for marketing, and have nothing to do with the expected use effect of medical devices.

I didn't notice the classification of adverse events. See what you want to classify them according to. Is the severity of the consequences?

However, according to the regulations, all adverse events need to be reported:

Under normal use, an event that has nothing to do with the expected use effect of the medical device happens to the qualified medical device that has been approved for marketing, and may or has caused death or serious injury to the patient; Focus on monitoring all adverse events of varieties.

Hospitals require real-time reporting, and enterprises require annual reporting of adverse events. The table names used in different regions will be slightly different, but the basic contents are similar.

There is a national reporting system: the National Adverse Drug Reaction Monitoring System.

At present, there is no time limit mentioned in the regulations, and the general requirement is real-time. However, if you don't report a problem, you won't find it if no one reports it.

In Guangzhou, adverse events should not be reported, and they must be informed in writing.

General users or hospitals report adverse events, and the provincial bureau will also notify enterprises.