2026 Latin America Clinical Trial & Device Registration Regulatory Guide — bioaccess®
A comprehensive guide to clinical-trial authorization and medical-device registration requirements across 19 Latin American & Caribbean countries. bioaccess® manages ethics-committee and national-regulator submissions under ISO 14155 (device GCP) and ICH E6 (drug GCP), with conducted under good clinical practice (ISO 14155) so the resulting data is eligible for FDA acceptance under 21 CFR 812.28 — acceptance is determined by FDA on a submission-by-submission basis.
Regulators by country
- Colombia — INVIMA
- Brazil — ANVISA
- Mexico — COFEPRIS
- Argentina — ANMAT
- Chile — ISP
- Peru — DIGEMID
- Panama — MINSA
- Ecuador — ARCSA
- El Salvador — DNM
- Dominican Republic — DIGEMAPS
Ethics & registration timelines
Typical timelines as of July 2026; actual review times vary by classification and health-authority queries, which pause statutory clocks.
- Ethics/IRB approval for clinical studies: typically 4–8 weeks across LATAM; Panama in as little as 15–30 calendar days.
- Device registration (varies by class): ANVISA (Brazil) notificação for Class I/II or registro subject to statutory maximums up to ~250–365 days for Class III/IV; COFEPRIS (Mexico) ~30/35/60 working days by class, with a ~30-working-day equivalence-route (vía abreviada) target for eligible devices; INVIMA (Colombia) automatic issuance for Class I/IIa or ~90 business days for Class IIb/III; ANMAT (Argentina) sworn-declaration prior notice for imported Class I/II devices (Disp. 236/2026, art. 2) and 15-business-day declarations of conformity for locally made Class II (Disp. 9688/2019, art. 5).
- Statutory review clocks pause during health-authority queries.
Country regulatory guides
Detailed country guides: Colombia · Brazil · Mexico · Argentina · Chile · Peru · Panama · Ecuador · Dominican Republic · Costa Rica
Related: Medical Device Registration & Market Access · LATAM Importer of Record
This guide is for general informational purposes only and is not regulatory or legal advice; confirm current requirements with the applicable health authority or with bioaccess®.
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