Country comparison
Clinical investigation & performance by country
Which clinical or IVD performance evidence or study is required and accepted?
1 markets1 facts1 official sourcesreviewed through 2026-08-24
| Market | Source-linked requirements | Official sources | Last checked |
|---|---|---|---|
| 🇧🇷 Brazil ANVISA All country facts → | DICD submission scope A clinical investigation involving an unregistered Class III or IV medical device is subject to a DICD submission; the DICD must be submitted to ANVISA before the investigation is conducted. | 2026-08-24 |
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