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: varies by study; we confirm per protocol across LATAM; Panama on a timeline that varies by study (we confirm it per protocol).
• Device registration (varies by class): ANVISA (Brazil) notificação for Class I/II or registro subject to statutory maximums of ~250 days (equipment), 320 (materials) or 365 (IVD); 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 once the file is complete (Decreto 582/2017 art. 1); 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®.

Request the full guide · Book a Meeting