Brazil · ANVISA
ANVISA Brazil medical device registration
Registration runs through ANVISA under RDC 751/2022 and RDC 848/2024. Our kits help you prepare the file right the first time.
Brazil documentation kits
Prepared against RDC 751/2022 and RDC 848/2024.
How registration works
Six steps. The kits cover steps 3 and 4.
01
Classify
Class I–IV under RDC 751/2022.
02
Appoint a BRH
Your Brazil Registration Holder.
03
Gap analysis
Close gaps before filing.
05
Submit
BGMP first for Class III/IV.
06
Decision
ANVISA reviews; you sell.
04
Compile the dossier
On the IMDRF table of contents.
Magenta steps are where the kits do the heavy lifting.
Two pathways
The route, and the documents you need, depend on the device class.
Notification
Class I & II · lower risk
Notification form
Manufacturer Authorization Letter
Labelling and IFU in Portuguese
Proof of compliance (+ SBAC if required)
Registration
Class III & IV · higher risk
Technical dossier
Manufacturer Authorization Letter + Certificate of Free Sale
BGMP certificate (ANVISA inspection or MDSAP)
Proof of compliance (+ SBAC if applicable)
Prepared once, filed right
The ANVISA structure, the RDC 848/2024 requirements and the dossier templates, ready to fill.
See the Brazil kitsNeed a hand?
Want it done for you?
We can review your file or take on the full ANVISA submission.
Common questions
Yes. A foreign manufacturer cannot register directly; a Brazil-based BRH holds the registration and is ANVISA's point of contact.
Brazil Good Manufacturing Practices, required for Class III and IV. Issued by ANVISA after inspection, or accepted under MDSAP.
INMETRO for electrical devices, ANATEL for wireless, INCQS for certain IVDs. These are in addition to ANVISA.
Labelling and IFU must be in Brazilian Portuguese.