Country comparison
Special access & derogation by country
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
1 markets2 facts1 official sourcesreviewed through 2026-08-24
| Market | Source-linked requirements | Official sources | Last checked |
|---|---|---|---|
| 🇧🇷 Brazil ANVISA All country facts → | Custom-made first-device filing lead time minimumDaysBeforeFirstManufactureOrImport: 30 Custom-made device route Custom made devices do not require ANVISA registration under RDC 751/2022, but they require pre market sanitary control through manufacturing or import consent and a manufacturing or import notification under RDC 925/2024. | 2026-08-24 |
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