🇦🇷 Argentina medical device regulatory data

Type

Fixed Term

Description

5 years; reválida (renewal) application must be filed within the last 90 days of validity

Class I and II reválida applications must be filed within the 90 days before registration expiry.

Archetype

Marketing Authorization Holder Or Registrant

Name

ANMAT-habilitated importer/manufacturer holding the product registration

Required For Foreign

yes

Registration Relation

Holds Or Applies For Registration

Importer Relation

Often Same

Distributor Relation

May Be Separate

Combination

Allowed Subject To Establishment Authorization

Note

All medical-device importers without exception require ANMAT habilitación (Disposición 2319/02 t.o. 2004) and product registration; foreign manufacturers reach the market through the habilitated local company. Interprovincial IVD-reagent distributors also require ANMAT habilitación.

Label Ifu

Spanish

Submission

Spanish; foreign documents must be legalized/apostilled and translated by a public translator

Status

Verified Official

Device labels must state, in Spanish, at least: manufacturer/importer name and address, product identification, the word 'estéril' where applicable, lot number or serial number, manufacture and expiry dates, single-use indication where applicable, storage conditions, warnings/precautions, sterilization method where applicable, the responsible technical professional, and the ANMAT registration number.

For listed implants (cardiac and vascular circulatory implants, CNS implants, spinal implants, hip and knee prostheses, breast prostheses, intraocular lenses) an implant card must carry product name/model, lot or serial number, manufacturer and importer name/address, and ANMAT registration number, with blank fields for the implanting center, implantation date and patient ID; it is issued in triplicate (patient record, patient, financing entity).

ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), a decentralized autarchic body under the Ministerio de Salud, is the competent authority for medical devices and IVDs nationwide.

Ley 16.463 subjects the import, export, production, elaboration, fractioning, marketing and warehousing of medicinal specialties and medical technology products to prior authorization and control by the health authority, in establishments enabled by it.

Medical-device registration is governed by MERCOSUR Resolución GMC 25/21, incorporated into Argentine law by Disposición ANMAT 64/2025 (published in the Boletín Oficial on 13 January 2025), which derogates Disposiciones ANMAT 2318/02 and 1285/04.

Disposición ANMAT 8194/2023 is the current post-market tecnovigilancia regime for medical devices, replacing Disposiciones ANMAT 8054/10 and 7485/11.

'Producto médico' under MERCOSUR GMC Res. 25/21 covers any instrument, apparatus, equipment, implant, in-vitro diagnostic product, software, material or other article intended by the manufacturer for medical use in humans.

Registration route splits by class: Class I and II registrations, modifications and reválidas are processed under Disposición ANMAT 5706/2017 (Art. 1); Class III and IV registrations under Disposición ANMAT 727/2013 (Art. 2), with their data modifications also under 5706/2017; IVDs under Disposición ANMAT 2198/2022. All routes end in the Registro de Productos Médicos.

IVDs (reactivos de diagnóstico in vitro) in Groups A and B are registered by Declaración de Conformidad (declaration of conformity), with 15 administrative working days for ANMAT to evaluate the documentation.

Target

geo:arg

SourceApproval

Medical Device Single Audit Program

EdgeType

Qms Audit Reliance

Membership

Affiliate Member

MarketAccessStrength

Evidence Only

RegulatoryLayer

Qms Audit

LocalApplicationRequired

Yes

Note

FDA lists ANMAT among MDSAP Affiliate Members (not full members); MDSAP audit reports/certificates serve as evidence within ANMAT processes and do not create product authorization or a BPF waiver.

At inscription of a product already authorized by a foreign health authority with an equivalent regulatory framework (with official free-sale certificate), the applicant is exempt from certain dossier items: Art. 2 incisos f) and g) and Art. 3 incisos e), g2) and g3) of Disposición ANMAT 727/2013.

The establishment's BPF (Buenas Prácticas de Fabricación) certificate and its habilitación certificate must be presented jointly: the authorized scope and its validity are determined by the BPF certificate, so presenting either document separately has no validity.

Since 6 August 2025 (Disposición ANMAT 4446/25), imports of Class I and II medical devices require an AVISO DE IMPORTACIÓN (sworn-declaration import notice) filed in the BONITA system up to 48 hours after nationalization; the notice is free of charge and prior ANMAT import authorization for these classes was eliminated.

Class III and IV devices, all IVDs, temporary imports of medical devices, and samples of unregistered products (any class) still require prior ANMAT import authorization. Direct users (non-profit healthcare establishments) may import any class through the TAD procedure.

Foreign documents in Class III/IV registration dossiers must be legalized under the Consular Regulation or by Hague Apostille and translated by a public translator (traductor público).

The certificate of registration or free sale from the country of origin submitted with Class III/IV registration applications must be no older than 24 months.

For registration of an imported device, the manufacturer's declaration may be up to 2 years old from issuance and must be legalized or apostilled; proof of registration, a free-sale certificate or an equivalent document must also be submitted.

Since 1 November 2017 all trámites under Disposición ANMAT 5706/2017 (Class I/II registration, modification, reválida) must be filed electronically through the Sistema HELENA; both the Director Técnico and the apoderado must hold an ANMAT digital signature.

Official ANMAT systems: GHEMA (habilitación of manufacturer and importer establishments), HELENA (electronic product registration, including IVDs), BONITA (import management, incl. import notices), ARGOS (adverse-event and field-safety-corrective-action reports), THEMIS (régimen simplificado per Disposición 8799/2025).

Iso Relation

Local Qms With Iso Evidence

Local Regime

BPF (Buenas Prácticas de Fabricación) per Disposición ANMAT 194/99 required for registration; BPF certificate and habilitación certificate must be presented together.

Iso Role

ISO 13485 is supporting evidence, not an automatic BPF waiver.

Mdsap Role

Affiliate Audit Report And Certificate Use

The 15-administrative-working-day review clock for Class I/II trámites is suspended until the applicant supplies the missing information or documentation (stop-clock rule).

Approved modifications and changes do not restart the registration clock: the product keeps its original 5-year validity and expiry date.

The Sistema Nacional de Trazabilidad de Productos Médicos, created by Resolución 2175/2013, is the tool against illegitimate commerce; products are verified by GTIN (Global Trade Item Number, the 13-digit number after (01) on the label/traceability support) plus a unique alphanumeric serie (up to 20 digits, after (21)).

Devices intended for research or clinical trials are exempt from registration, provided the legal provisions of the competent health authority for such activities are met; commercialization and any other use are prohibited.

ANMAT is the body responsible for authorizing and controlling experimental clinical investigations in medicines, food and medical products, and for issuing the governing regulation; approval verifies scientific and ethical standards, licensed (matriculated) professionals and habilitated sites, with ANMAT inspection powers.

Unregistered devices may be imported for a named patient whose disease endangers life or quality of life (uso compasivo), under individual ANMAT authorization through the TAD portal (free, fully online). The dossier includes the device history (foreign authorizations with diplomatic legalization, ongoing foreign trials), a publication indexed in Index Medicus, a risk/benefit justification signed by the treating physician and endorsed by the ethics committee, and signed informed consent; documents must be signed and stamped on every page by the responsible physician.

Custom-made devices (productos médicos confeccionados a medida, under the conditions of Anexo IV) are exempt from registration; they must be manufactured under BPF by habilitated establishments and carry the special label (rótulo especial) conforming to the model of Anexo V.

All holders of medical-device registrations authorized by ANMAT must comply with the post-market tecnovigilancia duties of Disposición ANMAT 8194/2023.

Registration holders must establish, elaborate, maintain and keep available to ANMAT trend reports (informes de tendencia) as part of post-market surveillance.

Any serious threat to public health must be reported within 48 hours; incidents involving death or serious deterioration of health must be notified within 10 calendar days of becoming aware.

Field safety corrective actions (FSCA) must be reported to ANMAT within 10 calendar days counted from their implementation.

Tecnovigilancia submissions must be processed through the ANMAT digital platform available for that purpose (ARGOS, the ANMAT system for adverse-event and field-safety-corrective-action reports).

Disposición ANMAT 8194/2023 provides for the 'Nota de Seguridad en Campo' (field safety notice) as the communication instrument linked to field safety corrective actions.

When illegitimate product is detected, ANMAT market-control actions include a nationwide prohibition on use and commercialization of the involved manufacturing lot, together with traceability tracking of units and coordination with jurisdictions.

Under Disposición ANMAT 4059/25, only products holding the corresponding authorization may be advertised. For devices, the covered scope is products authorized with the condition 'uso sin prescripción' (per Art. 22 inc. c, Disposición 9688/19); self-testing IVDs (para autoevaluación) are included in the scope.

Advertising for medical devices must include the legend 'LEA ATENTAMENTE LAS INSTRUCCIONES DE USO. ANTE LA MENOR DUDA CONSULTE A SU MÉDICO'.

A party may file a recurso de reconsideración (reconsideration appeal) against an ANMAT act within 20 days of notification, under the national administrative-procedure regulation applicable to ANMAT decisions.

The recurso jerárquico (hierarchical appeal) must be filed before the authority that issued the challenged act within 30 days; acts of autarchic entities such as ANMAT may also be challenged by recurso de alzada before the Ministerio de Salud.