Cadastro vs. registro
Class I/II cadastro in ~30 days vs. Class III/IV registro in 9–20 months — plus the mandatory Brazilian Registration Holder.
Free field guide · PDF
Brazil ANVISA Medical Device Registration2026 Field Guide
Cadastro vs. registro, the BRH and BGMP rules, and INMETRO certification — for South America's largest medical device market.
- Class I/II route
- 30 days
- Class III/IV timeline
- 9–20 mo
- INMETRO validity
- 5 yrs
Sourced from ANVISA regulation guidance and INMETRO certification practice.
Download the free guide
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — ANVISA regulation guidance and INMETRO certification practice.
The two extra gates
BGMP certification for Class III/IV sites (2-year validity) and INMETRO certification for electromedical devices (5-year validity).
The practical playbook
Everything in Portuguese, realistic $15K–$35K+ budgets, correct sequencing, and why Brazil must be treated as standalone.
Sources & scope
- Chambers Expert Focus, the new Brazilian medical device regulation.
- Med Device Online, understanding medical device regulation in Brazil.
- TÜV SÜD, INMETRO certification for medical devices sold in Brazil.
- IndexBox, Brazil diagnostic equipment market report 2026.
This guide is market-access intelligence, not regulatory or legal advice. ANVISA pathways and INMETRO scopes are product-specific — professional review is required before business use.
Market Access Strategy Session
Brazil on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your ANVISA registration route — BRH, BGMP, and INMETRO sequencing.
Professional review is required before business use.
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