Specific Timelines

Medical device reporting timelines are very specific depending on the organization’s relationship to the medical device (i.e. a manufacturer, versus an importer or user), the seriousness of the event, the country or region that is being reported too, and where the event occurred.

30 Calendar Days

In the U.S. Manufacturers have to report any deaths or serious injuries or malfunctions within 30 calendar days of becoming aware of the event, and report events which require remedial action to prevent substantial harm within 5 working days of becoming aware of the event.


Importers typically have 30 calendar days to report the deaths, injuries or serious malfunctions.  User facilities, (facilities which may be using the device) typically have 10 working days to report device-related deaths and serious injuries.