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