The pathways
Notification for Class I/II (~30 days) vs registro for Class III/IV (9–20 months) — with the BGMP and MDSAP picture.
Free field guide · PDF
Brazil ANVISA: Medical Device Registration2026 Field Guide
The pathways, the UDI database, and the local representative — with the registration practice you need.
- UDI in force
- Mar 2026
- Notification
- ~30 days
- Registro
- 9–20 mo
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The UDI database
Normative Instruction 426/2026: the national UDI database in force since 1 March 2026 — transmission, governance, and the voluntary window.
The BRH gate
Foreign manufacturers cannot hold a Brazilian authorization alone — the BRH, Brazilian Portuguese dossiers, and the SaMD inclusion.
Sources & scope
- pureglobal.com, ANVISA Normative Instruction 426/2026 on UDI Database.
- cbdl.org.br, official translation of IN No. 426/2026 (DOU 18/02/2026).
- chambers.com, The New Brazilian Medical Device Regulation (Expert Focus).
This guide is market-access intelligence, not regulatory or legal advice. ANVISA pathways, timelines, and documentation practice change — professional review is required before business use.
Market Access Strategy Session
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A Market Access Strategy Session maps your ANVISA route — pathway selection, BRH readiness, and UDI compliance.
Professional review is required before business use.
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