Pure Global AI
Country comparison

Vigilance & incident reporting by country

What is reportable, by whom, where, in what format, and by what deadline?

1 markets1 facts1 official sourcesreviewed through 2026-08-24
MarketSource-linked requirementsOfficial sourcesLast checked
🇧🇷 Brazil
ANVISA
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Technovigilance reporting deadlines

72Hours: death; serious public health threat; counterfeit · 10CalendarDays: serious adverse event without death; non serious event whose recurrence could cause a serious adverse event; specified foreign death, serious public health threat, or counterfeit events · 30CalendarDays: A qualifying technical complaint that could lead to a serious adverse event.

2026-08-24

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