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

bioaccess® answer: the registration holder owns the sanitary registration, and with it legal control of market access; the Importer of Record (IoR) is the entity that imports the device under that registration. Distributors who hold the registration legally own market access. bioaccess® acts as a neutral Registration Holder across our LATAM coverage so manufacturers keep regulatory control independent of any commercial distributor.

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° 016-2011-SA, as updated by Decreto Supremo N° 020-2024-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).
• Dominican Republic (DIGEMAPS) — a DIGEMAPS-licensed local establishment files and imports under the product owner's power of attorney; DIGEMAPS publishes a procedure to add co-distributors, each authorized by the titular's power of attorney. bioaccess® does not act as holder or importer in the Dominican Republic. Titular, representative and co-distributors in the Dominican Republic.

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) — Resolución 226/2024, Art. 6(b): the importer named in the manufacturer's representation letter applies; an exclusive letter takes priority.
• Ecuador (ARCSA) — registration must be held by a local Ecuadorian company; single holder. Per Resolución ARCSA-DE-026-2016-YMIH (to be replaced by Resolución ARCSA-DE-2026-003-DASP, in force 28 January 2027), the sanitary registry certificate is issued in the name of the holder, who is responsible for its use.
• Panama (DNDM) — 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.
• Guatemala (MSPAS / DRCPFA) — single titular under Acuerdo Gubernativo 712-99 (as amended, including by Acuerdos Gubernativos 351-2006 and 104-2018, with Norma Técnica 37). bioaccess® does not act as the Guatemalan titular and does not sell a holder subscription in Guatemala. Manufacturer-funded processing is available. Holder, importer, and any transfer follow current MSPAS rules and local counsel. A contract does not override MSPAS.
• 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) — NTON 24001:2023 (which repealed Normativa 064) requires sanitary registration; the titular is the product owner, which authorizes its local distributor.
• 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.

• Uruguay (MSP) — the Local Holder controls the registration; a distributor that holds it has leverage over your imports. Not in bioaccess® coverage today.

bioaccess® two-part pricing

• Mexico (COFEPRIS): registration $5,000–$13,250 one-time; holder fee $4,500/yr from year 2 (includes technovigilance reporting (complaint intake, adverse-event and required periodic reports to the agency, and relaying field-safety notices you issue); recalls and field corrective actions are quoted separately)
• Colombia (INVIMA): registration $4,000–$9,000 one-time; holder fee $3,900/yr from year 2 (titular or apoderado)
• Brazil (ANVISA): registration $6,750–$22,250 one-time; holder fee $6,000–$7,500/yr from year 2 (includes technovigilance reporting (complaint intake, adverse-event and required periodic reports to the agency, and relaying field-safety notices you issue); recalls and field corrective actions are quoted separately)
• Peru (DIGEMID): registration $4,250–$10,500 one-time; holder fee $4,200/yr from year 2
• Argentina (ANMAT): registration $4,500–$12,000 one-time; holder fee $4,200/yr from year 2
• Chile and other markets quoted case by case.

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