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Country comparison

Recall, FSCA & market surveillance by country

Which recall, FSCA, notice, and authority-coordination duties apply?

1 markets2 facts1 official sourcesreviewed through 2026-08-24
MarketSource-linked requirementsOfficial sourcesLast checked
🇧🇷 Brazil
ANVISA
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Field-action trigger

The registration holder must initiate a field action as quickly as possible when sufficient indications or proof show that a marketed device does not meet its applicable essential safety and efficacy requirements.

Field-action notification deadlines

3CalendarDays: large circulation media is needed for the alert; serious public health threat · 10CalendarDays: Risk of a serious adverse event when the 3 day cases do not apply. · 30CalendarDays: Other field action situations.

2026-08-24

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