ANVISA Brazil medical device registration
Around half of Brazil's medical devices are imported, making it one of the most attractive emerging markets — and one of the most exacting. Registration runs through ANVISA under RDC 751/2022 and the essential requirements of RDC 848/2024. MD Regulatory gives you the documentation to prepare that submission correctly, the first time.
Brazil documentation kits
Prepared against RDC 751/2022 and RDC 848/2024.
A prepared submission, not a guess
Our kits are built from the ANVISA regulations themselves — not summaries — and mirror the technical file a Class III/IV registration actually needs.
How registration works
Six steps from classification to market. The MD Regulatory kits carry steps 3 and 4.
Steps in magenta are where the MD Regulatory kits do the heavy lifting.
Two regulatory pathways
Notification
Registration
What documentation is required
The dossier depends on whether the device follows the Notification or the Registration route.
For Notification (Class I & II)
For Registration (Class III & IV)
Prepared once, filed right
That is exactly the file the kits already carry — the ANVISA structure, the essential requirements of RDC 848/2024 and the technical dossier templates. So the file you submit is the file they expect.
See the Brazil kitsNot sure which kit — or want it done for you?
Talk to the regulatory team behind these kits. We can help you choose the right one, or take on the full ANVISA submission as a consulting engagement.
Common questions
Ready to prepare your ANVISA file?
Start with the gap analysis, or take the complete Brazil bundle.