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

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 Country Incident/Event Severity Reporting Timelines Reporting Person Required Annual Report?Other Countries incidents can be reported?
  United StatesDeath, serious injuries, malfunctions30 daysManufacturer, User, Importer, and probably distributor  Yes         YesWithin 30 days
Remedial action required to prevent the risk of substantial harm5 days
  EuropeDeath or serious deterioration of health10 days  Manufacturer  No  No
Serious public health threat2 days
Serious Incidents15 days
    BrazilDeath 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
   AustraliaSerious public health threat48 hours  Manufacturer and Sponsor   Yes   No
Death or serious deterioration of health10 days
Recurrence could lead to death or serious health deterioration30 days
   CanadaDeath or serious deterioration of health10 days Manufacturer and Importer  No  No
Recurrence could lead to death or serious health deterioration30 days
 JapanDeaths plus faults, breakage & malfunctions15 daysMarket     authorization holder  No  No
Serious Events30 days