Multi-Market Submission Strategy — Leveraging Approvals
For manufacturers targeting Brazil alongside other major markets, a coordinated multi-market submission strategy can significantly reduce duplication and time-to-market.
Recommended sequence for multi-market entry
For most manufacturers, the recommended sequence is:
- EU MDR / FDA first — these produce the most comprehensive clinical evaluation reports, risk management files, and technical documentation, which can be adapted for ANVISA.
- Australia (TGA), Health Canada, Singapore (HSA) — also accept and produce internationally compatible documentation.
- Brazil (ANVISA) — leverage EU/FDA/TGA documentation, translate into Portuguese, adapt to ANVISA format requirements.
Documentation reuse for Brazil
| Document from EU/US | Reusable for ANVISA? | Adaptation needed |
|---|---|---|
| CE MDR Clinical Evaluation Report (CER) | Yes | Translate to Portuguese; add Brazil-specific population data if needed |
| ISO 14971 Risk Management Report | Yes | Translate; confirm ABNT NBR ISO 14971 compliance |
| ISO 13485 GMP certificate | Yes | Submit with Registro dossier as evidence of GMP compliance |
| IEC 62304 Software documentation | Yes | Translate key sections |
| Essential Requirements Checklist (EU MDR Annex I) | Partially | Map to ANVISA Essential Requirements (RDC 751/2022 Annex II) |
| FDA 510(k) / PMA clinical data | Yes | Accepted by ANVISA with appropriate translation |
Language is the main barrier
The primary additional effort for Brazil compared to other IMDRF markets is translation to Portuguese. Invest in high-quality medical-regulatory translation from the outset — ANVISA reviewers will flag translation errors as deficiencies.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.