Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets

March 13, 2020 | Medical Device

Prior preparation is necessary for an immediate investigation of incidents once they occur. This is necessary not only because you are keen on ensuring patient safety but also as immediate action has been made mandatory by the Regulatory Authorities. It ensures the fact that no further harm is caused to the patient or the user.

Your time starts right at the moment when you come across an incident that needs to be reported. The crucial part is to estimate the time within which the incident needs to be reported and it generally depends on the severity of the incident. Timelines include all the days of the week and not only working days, need this to be kept in mind. Remember that when a report is filed about an event/incident, it does not necessarily mean that your device has caused it or that you are liable for it. If you are in doubt then you should always report.

What Needs to Be Reported?

The timeline and criterion of reporting are different for every country. Still, in general, a report needs to be filed with relevant medical device Regulatory Body under the following circumstances:

When there is a severe deterioration of health or even death.
With the emergence of a serious threat to public health.
Development of a trend that is continuously negative.
With the issuance of a field safety corrective action (FSCA) or that of a recall.

Moreover, if you have sufficient labeling, it is not necessary to report when:

There is a minimum chance of death or any serious event.
Mistake from the patient/user resulted in the incident.
Incident occurred after the expiry of the device’s shelf life or service life.
Side effects were revealed after prior prediction.
The user had previously detected an issue with the device before using it.
The fault mechanism of the device acted as per the design.

Country	Incident/Event Severity	Reporting Timelines	Reporting Person	Required Annual Report?	Other Countries incidents can be reported?
United States	Death, serious injuries, malfunctions	30 days	Manufacturer, User, Importer, and probably distributor	Yes	YesWithin 30 days
	Remedial action required to prevent the risk of substantial harm	5 days
Europe	Death or serious deterioration of health	10 days	Manufacturer	No	No
	Serious public health threat	2 days
	Serious Incidents	15 days
Brazil	Death or serious deterioration of health	72 hours	Manufacturer and registration holder	No	YesWithin 10 days
	Serious adverse event but not death	10 days
	Recurrence could lead to death or serious health deterioration	30 days
Australia	Serious public health threat	48 hours	Manufacturer and Sponsor	Yes	No
	Death or serious deterioration of health	10 days
	Recurrence could lead to death or serious health deterioration	30 days
Canada	Death or serious deterioration of health	10 days	Manufacturer and Importer	No	No
	Recurrence could lead to death or serious health deterioration	30 days
Japan	Deaths plus faults, breakage & malfunctions	15 days	Market authorization holder	No	No
	Serious Events	30 days