Q1 2026 produced the most consequential cluster of medical device market access rules Latin America has issued in a decade. Colombia is rewriting the foundational decree from 2005, Argentina has formalized the import of refurbished equipment, and Brazil's medical council has set the first hospital-level AI governance rules.
Colombia · Argentina · Brazil
The first quarter of 2026 produced the most consequential cluster of medical device market access rules Latin America has issued in a decade. Colombia is rewriting the foundational decree that has governed device commercialization since 2005, Argentina has formalized the import of refurbished equipment, and Brazil's medical council has set the first hospital-level governance rules for AI in medicine. The cumulative effect is a meaningfully different operating environment for device manufacturers across the region.
The Ministry of Health published a draft decree in early January 2026 that would replace Decree 4725/2005 and Decree 3770/2004 — the foundational rules that have governed Colombia's medical device market since the mid-2000s. Under the proposal, market authorization is granted in three tiers tied to risk: low- and moderate-risk devices receive a sanitary notification, high- and very-high-risk devices a sanitary registration, and controlled-technology biomedical equipment a separate commercialization permit. The draft also introduces explicit post-market surveillance, full life-cycle obligations, and joint liability between authorization holders, importers, and manufacturers.
Source: MinSalud draft decree (Infobae summary, Jan 2, 2026): https://www.infobae.com/colombia/2026/01/02/gobierno-expidio-nuevo-regimen-sanitario-para-dispositivos-medicos-en-colombia-estos-son-los-puntos-clave-del-borrador-de-decreto/
Business implication: Manufacturers built dossiers around Decree 4725/2005's MDD-style structure should plan for a second-cycle update. Foreign companies should expect heavier post-market evidence obligations and a meaningful rewrite of how authorization holders allocate risk with their Colombian importers.
Phase 3 of INVIMA's Unique Device Identifier (UDI-DI) regime under Resolution 1405 of 2022 closed on February 8, 2026. Class IIa medical devices and Category I IVDs registered before February 7, 2024 must now have their UDI-DI codes reported and validated against the INVIMA semantic standard. Non-compliant products face suspension of commercialization, establishment closure, and product seizure under Law 9 of 1979 enforcement powers.
Source: INVIMA technical annexes for Resolution 1405 of 2022: https://www.invima.gov.co/biblioteca/anexos-tecnicos-estandar-semantico-resolucion-1405-2022
Business implication: Class IIa device holders that have not yet completed UDI-DI reporting are now operating outside the regulatory standard and face concrete suspension risk on inspection. Validation must include the GMDN code, manufacturer data, risk classification, and commercial presentation — and corrections must be filed before any commercialization resumes.
ANMAT issued Disposition 224/2026 on January 30, 2026, published in the Official Bulletin February 2, 2026. The rule replaces the 2007 framework (Disposition 806/2007) and creates three import pathways for used medical equipment that holds a valid ANMAT registration: refurbished abroad, used and not requiring refurbishment, and used and to be refurbished domestically. Single-use devices are excluded. Effective date: 45 business days after publication. The measure implements Decree 273/2025's broader liberalization of used capital-equipment imports.
Sources:
Business implication: Refurbishers, asset-recovery operators, and OEMs running trade-in programs now have the first defensible legal pathway into Argentina in nearly two decades. Smaller hospitals and diagnostic centers gain access to imaging and capital equipment at materially lower acquisition cost — which expands the addressable installed base for service contracts, consumables, and software upgrades.
The Federal Council of Medicine published Resolution 2,454/2026 in the Official Gazette on February 27, 2026 (signed February 11). The resolution takes effect August 10, 2026, 180 days after publication. It requires Brazilian medical institutions deploying AI to classify each system by risk level (low, medium, high, unacceptable), maintain continuous auditing, document AI use in patient records, inform patients when AI assists diagnosis or treatment, and — where institutions deploy their own AI — establish an internal AI and Telemedicine Committee under medical leadership.
Source: CFM Resolution 2,454/2026 official PDF: https://sistemas.cfm.org.br/normas/arquivos/resolucoes/BR/2026/2454_2026.pdf
Business implication: AI MedTech vendors selling into Brazilian hospitals now face hospital-level procurement filters in addition to ANVISA registration. Sales materials must document risk classification, human-in-the-loop controls, audit logs, and LGPD compliance to clear hospital AI committees. Contract architecture should anticipate joint physician-vendor responsibility under the resolution's liability framework.
The agency's final 2026-2027 Regulatory Agenda, published December 2025, lists Tema 5.11 — a comprehensive revision of RDC 657/2022 governing Software as a Medical Device. The agenda also flags Tema 5.7 (regulation of innovation in medical devices) and Tema 5.8 (in-vitro diagnostic devices subject to prior analysis) as priority items, alongside a separate workstream on mandatory MDSAP participation for international manufacturers (Revision of RDC 687/2022).
Source: ANVISA 2026-2027 Regulatory Agenda (final list PDF): https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao/agenda-regulatoria/agenda-2026-2027/arquivos/portal_lista_final_ar_2026-2027.pdf
Business implication: ANVISA has signaled — on its own primary planning document — that SaMD and AI-driven device rules are coming. Foreign manufacturers should treat the 2026-2027 window as the inflection point for Brazilian software-as-device strategy and plan their next dossier cycle around an updated SaMD framework, not RDC 657/2022 as written.
Need help navigating LATAM regulatory pathways? bioaccess® provides market access services with U.S. regulatory anchoring and Latin American execution — from device registration to commercial launch. Visit bioaccessla.com/market-access.
← All LATAM Regulatory Dispatch editions · Contact bioaccess®