With IVF and ART adoption surging across Latin America, entering these markets means navigating evolving regulatory systems. This updated 2025 guide provides country-specific requirements, recent reforms, and practical tips for the region’s largest markets.
Brazil – ANVISA
Devices classified under RDC 751/2022 (Classes I-IV). Technical dossiers must follow the IMDRF non-IVD MA Table of Contents and meet Essential Safety and Performance Requirements per RDC 546/2021. RDC 810/2023 amendments may impact IVF devices.
Key Requirements:
- Local Registration Holder in Brazil (Cadastro Nacional)
- Portuguese documentation
- INMETRO for electrical equipment
- GMP (CBPF) mandatory for Class III/IV
- Labeling must identify Notification/Registry Holder; legacy devices require updates
Timelines: Class I/II: 3–6 months (indefinite validity); Class III/IV: 9–18 months (valid 10 years)
Tip: Use experienced RA consultants for dossier structuring and INMETRO compliance.
Mexico – COFEPRIS
As of Dec 1, 2025, NOM-241-SSA1-2025 replaces NOM-241-SSA1-2021, mandating ISO 13485 compliance across the device lifecycle. Device classification now follows the Mexican Pharmacopoeia Supplement. UDI implementation is paused.
Key Requirements:
- Local legal entity as Appointed Holder
- ISO 13485 or local GMP certificate
- Documentation: product details, IFU, testing results, risk analysis
- Spanish submission
Timelines: 4–9 months for most Class II/III devices (subject to transition periods)
Tip: Use the Equivalency Pathway for FDA, Health Canada, or Japan-approved devices.
Colombia – INVIMA
Regulated under Decreto 4725/2005 with EU MDR-style classification interpretation.
Key Requirements:
- Colombia-based Local Holder
- Dossier: specs, test data, safety validation, labeling
- Spanish documentation
- Monitor INVIMA site for clinical data requirements and e-submission updates
Timelines: Class IIa/IIb: 4–6 months; Class III: 6–12 months
Tip: Align IFU and labeling with local terminology.
Argentina – ANMAT
Registrations now processed through the Helena platform for all classes. Risk management reports required for domestic manufacturers (except Class I).
Key Requirements:
- Local Agent for registration & post-market duties
- Spanish documentation
- Technical file: product details, safety/performance evidence, manufacturing certificates
Timelines: Class I/II: 15–30 days; Class III/IV: 60–120 days (total process 12–15 months)
Tip: Work with agents experienced in Helena platform submissions.
Common LATAM Pitfalls & Fixes
| Pitfall | Impact | Fix |
| Poor Spanish/Portuguese documentation | Delays/rejection | Certified translators + native RA reviewers |
| Inactive local holder | Missed follow-up | Vet based on responsiveness & track record |
| Misclassification | Wrong pathway | Pre-consult with authorities |
| Ignoring INMETRO (Brazil) or NOM standards (Mexico) | Noncompliance | Map technical standards early |
| Not adapting to new ISO 13485 requirements in Mexico | Rejections/delays | Update QMS and lifecycle processes |
Where FinDBest IVF Helps
We help manufacturers:
- Shortlist IVF-savvy distributors with RA expertise
- Compare partners in Brazil, Mexico, Colombia & Argentina
- Navigate timelines and compliance reforms with updated informative articles
- Accelerate entry with pre-vetted local agents
Disclaimer: This article is for informational purposes only and does not constitute legal or regulatory advice. Always consult local regulatory experts before starting the registration process.
Table of Acronyms
| Acronym | Meaning |
| ANVISA | Agência Nacional de Vigilância Sanitária (Brazil) |
| CBPF | Certificado de Boas Práticas de Fabricação (Brazil GMP Certificate) |
| COFEPRIS | Comisión Federal para la Protección contra Riesgos Sanitarios (Mexico) |
| GMP | Good Manufacturing Practices |
| IFU | Instructions for Use |
| IMDRF | International Medical Device Regulators Forum |
| INVIMA | Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia) |
| ISO | International Organization for Standardization |
| NOM | Norma Oficial Mexicana |
| RA | Regulatory Affairs |
| RDC | Resolução da Diretoria Colegiada (Brazil regulation) |
| SISA | Sistema Integrado de Información Sanitaria Argentino |
| UDI | Unique Device Identifier |
| QMS | Quality Management System |
