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
Language is the main barrier The primary additional effort for Brazil compared to other IMDRF markets is translation to Portuguese. All submissions to ANVISA, including clinical evaluation reports, risk management files, and technical specifications, must be translated by a qualified medical-regulatory translator. ANVISA reviewers will flag translation errors, inconsistencies with source documents, or unclear terminology as deficiencies that will delay or deny approval. Budget for professional translation and include time for potential revision cycles.
Verify all information against official ANVISA sources before making regulatory decisions.
Note: ANVISA does not currently recognise MDSAP certificates (which cover US FDA, Canada, Japan, and Australia). However, individual regulatory approvals from these jurisdictions can be leveraged for Brazil submissions with appropriate translation and adaptation.