Importer of record across Latin America — country-by-country guide

Which Latin American regulators allow multiple importers on one medical-device registration, and which require a single Importer of Record (IoR), with primary-source citations. bioaccess® acts as a neutral Registration Holder across our LATAM coverage so manufacturers keep regulatory control independent of any commercial distributor.

Multi-importer countries

• Mexico (COFEPRIS) — the Mexico Registration Holder can name multiple distributors and importers on a single sanitary registration.
• Colombia (INVIMA) — INVIMA explicitly contemplates "un titular con varios importadores" on a single registro sanitario.
• Peru (DIGEMID) — Decreto Supremo N° 001-2024-SA permits an independent Peru Registration Holder; additional droguerías can obtain their own CRS.
• Chile (ISP) — today — most general devices fall outside ISP's mandatory registration list; each importer pulls its own CDA per shipment. The pending Farmacos II law will tighten this.
• Brazil (ANVISA) — RDC 751/2022 names a single detentor de registro, but ANVISA permits the detentor to authorize multiple importadores under one registration; importers can be added or removed without re-registering the device (RDC 270/2019).

Single-IoR countries

• Argentina (ANMAT) — the Argentina Authorized Representative is the registration holder and the importer of record; one AAR per registration. Foundational Disposición ANMAT N° 2318/2002 was abrogated and replaced by Disposición ANMAT N° 64/2025.
• Paraguay (DINAVISA) — "El solicitante del registro sanitario deberá ser único representante."
• Ecuador (ARCSA) — registration must be held by a local Ecuadorian company; single holder. Per Resolución ARCSA-DE-026-2016-YMIH (reformed by ARCSA-DE-2023-033-AKRG), the sanitary registry certificate is issued in the name of the holder, who is responsible for its use.
• Dominican Republic (DIGEMAPS) — single local Authorized Representative. DIGEMAPS was created by Decreto 82-15 (2015); registration and import rules are set by Decreto 246-06.
• Panama (DNFD) — single Authorized Representative model.
• Costa Rica — single Costa Rica Registration Holder (CRH) imports under the registration, per Reglamento Técnico RTCR 505:2022 and Decreto Ejecutivo N° 37988-S under Ley General de Salud N° 5395; the CRH may authorize downstream distributors on the registration.
• Uruguay (MSP) — the Local Holder is the only entity authorised to import. Not in bioaccess® coverage today.
• Guatemala (MSPAS / DRCPFA) — single titular del registro under Acuerdo Gubernativo 712-99 (updated by Acuerdo Ministerial 01-2024); MSPAS publishes a formal cession-of-rights procedure to change the titular.
• El Salvador (SRS) — since 7 August 2024 the Superintendencia de Regulación Sanitaria (successor to DNM under the Ley de la Superintendencia de Regulación Sanitaria) regulates medical devices; single local legal representative per registration.
• Honduras (ARSA) — Acuerdo No. 0631-ARSA-2023 (effective 28 December 2023) requires a local legal representative domiciled in Honduras for each registration.
• Nicaragua (MINSA / ANRS) — Normativa 064 (Norma para el Registro de Dispositivos Médicos) requires sanitary registration held by the local importing entity.
• Bolivia (AGEMED) — sanitary registration is issued to a single local entity per device under AGEMED's Manual para Registro Sanitario (T-N-11-RM-0909).
• Venezuela (INHRR) — INHRR registers medical equipment and materials through SIVERC; single registrant per registration (U.S. sanctions are a material constraint).
• Cuba (CECMED) — sanitary registration required under Resolución Ministerial 184/2008 and Resolución CECMED 19/2024 (Reglamento E 119-24); OFAC sanctions apply to U.S. manufacturers.
• Jamaica (MoH&W — Standards and Regulation Division) — Food and Drugs Act, 1964: registration names a single local representative; products are imported under MoH-issued permits.
• Trinidad and Tobago (CFDD) — Food and Drugs Act, 1960: no new drug or device may be imported, sold or advertised unless the Minister has issued a notice of approval to the manufacturer or importer.
• Belize (Drug Inspectorate Unit, MoH&W) — Food and Drugs Act, 1973: only licensed importers with a registered pharmacist in charge may import devices.
• Guyana (GA-FDD) — Food and Drug Act Chapter 34:03 and Food and Drug Regulations: importers must register with GA-FDD and obtain a Permit to Import; ISO 13485:2016 and MDSAP certification required for the manufacturer, plus a Free Sale Certificate.

Other markets

Haiti — DPM/MT (MSPP) registers medications for human use but does not currently administer device-specific sanitary registration; pharmaceutical importers licensed by DPM/MT may import devices in that capacity. Suriname is a bespoke market — the Suriname Standards Bureau (SSB) and the Ministerie van Volksgezondheid administer the framework, and device registration is scoped per product. Sponsors should contact bioaccess® to scope the pathway. Puerto Rico is under U.S. FDA jurisdiction. French Guiana is under EU MDR.

bioaccess® flat per-country pricing

• Standard: USD 7,500 per year per country (entire device portfolio)
• Mexico: USD 10,000 per year (COFEPRIS)
• Brazil: USD 12,000 per year (ANVISA Class III/IV)
• Multi-country discounts: 10% off at 3+ countries, 15% off at 5+, 20% off for clinical-trial clients

Book a 30-min LATAM market-access call · See pricing