Risk classes I–IV, the Disposición 64/2025 framework, dossier documents, timelines, fees, import rules, and the one Argentine advantage no other Latin American market offers — answered in one place.
October 1, 2026
12
min read
By
BioAccess Editorial Team
Argentina
ANMAT
medical device registration
market access
Latin America
producto médico
Disposición 64/2025
**Key takeaways**
- • Registration is mandatory. Every medical device needs an ANMAT PM registration (producto médico) before import and commercialization in Argentina — no notification-only route.
- • The rulebook changed in 2025. Disposición ANMAT 64/2025 replaced the old 2318/2002 framework; classes I–IV now file through sworn-statement, declaration-of-conformity, or conventional routes depending on risk.
- • No direct foreign registration. The PM registration must be held by an Argentine-domiciled, ANMAT-habilitado establishment with a designated Responsable Técnico.
- • Argentina is the exception market. bioaccess® provides full titleholder AND importer-of-record services through its own Argentine entity — you do not need your distributor to hold the registration.
- • Validity is 5 years with an affirmative reválida (renewal) filing before expiry; imports now run on separate Class I/II and Class III/IV tracks.
**Who is this for?**
This guide is for regulatory affairs directors, market access managers, and MedTech executives planning to commercialize medical devices — implants, catheters, capital equipment, software as a medical device, and related products — in Argentina.
The short answer
To register a medical device with ANMAT, an Argentine-domiciled, ANMAT-habilitado establishment files a digital application through the HELENA platform. Risk classes I and II register through simplified routes — a sworn statement (Declaración Jurada) for the lowest-risk Class I products, or a Declaration of Conformity for other Class I and Class II devices. Classes III and IV undergo conventional full technical review by ANMAT's Instituto Nacional de Productos Médicos (INPM) and receive a PM number (e.g. PM 1842-474) with a Certificado de Autorización valid for 5 years. A foreign manufacturer cannot hold the registration in its own name. Argentina is the one market where bioaccess® holds the PM registration and imports directly through its own Argentine entity — see bioaccess®'s Argentina market access page.
What is ANMAT and which law governs device registration?
ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is Argentina's national health-products regulator. Its foundational legal framework rests on Ley 16.463 (the health-products framework law) and Decreto 1490/92 (which created ANMAT). Product registration today is governed by Disposición ANMAT 64/2025, which incorporates the Mercosur Resolución GMC 25/21 "Reglamento Técnico Mercosur de Registro de Productos Médicos" into Argentine law — and derogated Disposición ANMAT 2318/2002 (in force since 21 January 2025). Establishment authorization (habilitación) for manufacturers and importers is governed separately by Disposición ANMAT 2319/2002 (T.O. 2004), with the good-manufacturing-practice certificate regulated by Disposición ANMAT 3266/13 (valid 5 years). Post-market vigilance runs under the Tecnovigilancia program, with Good Tecnovigilancia Practices in Disposición ANMAT 8194/2023.
**The 2318/2002 framework is gone**
Much of the English-language literature on Argentina still cites Disposición 2318/2002. It was expressly derogated by Disposición 64/2025 (published in the Boletín Oficial on 13 January 2025). Any dossier strategy built on the 2002 text — including classification rules and document annexes — needs to be re-mapped against the 64/2025 framework and the classification-transition guidance ANMAT published in January 2025.
How are medical devices classified in Argentina?
Argentina classifies productos médicos into four risk classes — I, II, III, and IV — under the classification rules of Disposición ANMAT 64/2025 (incorporating Mercosur Resolución GMC 25/21). Classes I and II are the lower and moderate-risk classes; Classes III and IV are the higher-risk classes. The classification rules mirror the international risk-based approach: invasiveness, duration of body contact, active versus non-active, contact with the central circulatory or nervous systems, and whether the product incorporates medicinal substances or tissues drive the class — not simply whether the device is implantable.
| Class | Risk level | Typical examples |
|---|---|---|
| Class I | Low | Non-sterile, non-measuring, non-active devices; examination gloves, basic surgical instruments |
| Class II | Low–moderate | Diagnostic catheters, guidewires, powered basic equipment |
| Class III | Moderate–high | Coronary catheters, neurovascular devices, implants, devices incorporating medicinal substances |
| Class IV | High | Devices incorporating non-viable human/animal tissues, nanomaterial products, long-term implantables |
Getting the classification right at the start matters — it determines the registration route, the dossier depth, and which import track applies. Where the classification is genuinely unclear, ANMAT accepts a formal classification query via expediente through the TAD (Trámites a Distancia) platform under the concept "Consulta de clasificación de Productos" — an arancelado (fee-bearing) procedure.
Which registration route applies to each class?
Under Disposición 64/2025, classification determines the registration mechanism:
| Class | Registration mechanism | What it means |
|---|---|---|
| Class I (non-sterile, non-measuring, non-active, listed in the applicable annex) | Simplified — sworn statement (Declaración Jurada) | The holder files a sworn statement; the fastest path |
| Class I (all other) and Class II | Simplified — Declaration of Conformity (Declaración de Conformidad) | The holder's signed declaration is treated as proof of RPPTM registration |
| Class III | Conventional — full technical evaluation | INPM technical review; PM number granted by formal ANMAT disposition |
| Class IV | Conventional — full technical evaluation | INPM technical review; PM number granted by formal ANMAT disposition |
All filings run through HELENA — INPM's electronic platform for medical device registration, in operation since 2017 — and registered devices are entered in the RPPTM (Registro de Productos Médicos y Tecnología Médica). The holder must keep the underlying documentation at the establishment and available to the health authority for inspection.
Can a foreign manufacturer hold the registration directly?
No. The PM registration is granted to an Argentine-domiciled establishment — a fabricante or importador habilitado by ANMAT under Disposición 2319/2002. The authorized establishment must maintain a designated Responsable Técnico (technical responsible, typically a pharmacist), keep the registration documentation at the establishment for audit, and carry ongoing responsibility for the imported product. A foreign manufacturer cannot apply to ANMAT directly; it must act through an Argentine entity that holds the registration, communicates with ANMAT, and supports ongoing compliance.
**Argentina is the exception: bioaccess® is the titleholder and importer of record**
Unlike every other Latin American market — where we recommend appointing your distributor as titular and processing the filing as your third-party regulatory provider — in Argentina bioaccess® holds the PM registration and imports directly through its own Argentine entity. Full titleholder + importation services: the ANMAT establishment habilitation, the designated Responsable Técnico, HELENA filings, ANMAT liaison, customs clearance as importer of record, and tecnovigilancia through ARGOS. You do not need to appoint your distributor as titleholder, and there is no distributor-held registration to transfer if your commercial arrangements change — one accountable partner, no registration risk locked inside a distribution agreement. See bioaccess®'s Argentina market access page for the full service scope.
What documents does the ANMAT dossier require?
The document package depends on the registration route and whether the device is national or imported. For imported Class III/IV devices under conventional review, the expediente typically contains:
- Registration application through HELENA, signed by the legal representative and the Responsable Técnico
- Proof of payment of the applicable ANMAT fee (comprobante de pago de la tasa)
- Authorization from the foreign manufacturer or exporter for the Argentine importer to commercialize the device in the country
- Certificate of Free Sale (CFS) or equivalent document from the competent authority of the country of manufacture and/or marketing
- Evidence of origin-market authorization (e.g. FDA 510(k) clearance/PMA, EC certificate) for the models filed
- Product description: intended use, indications and contraindications, models and variants (family filings), ECRI/UMDNS technical code
- Design and manufacturing information; manufacturing-process and quality-control summary
- Risk management documentation (ISO 14971 or equivalent) and compliance with the essential safety and efficacy requirements (R.E.S.E., Disposición ANMAT 11467/24)
- Verification and validation data; biocompatibility, sterilization, packaging, and shelf-life summaries as applicable
- Clinical evaluation data — expected for Class III/IV devices
- Spanish labeling and instructions for use per the labeling annex of Disposición 64/2025 and the IFU format of Disposición ANMAT 9688/2019; authorized labeling carries the legend 'Autorizado por la ANMAT PM xxxx-xxx'
**Quality-system rule: ISO 13485 is not enough**
Argentina's legal requirement for establishments is the GMP (BPF) certificate under Disposición ANMAT 3266/13, not ISO 13485. ISO 13485 is common industry practice and useful for other markets, but it does not substitute for the Argentine GMP certificate. Documents drafted in a foreign language must be accompanied by their Spanish translation.
How long does ANMAT registration take?
No disposition sets a guaranteed end-to-end processing period for product registration itself under Disposición 64/2025. Adjacent procedures do have confirmed statutory clocks — establishment authorization (GEMHA) is 60 business days under Disposición 2096/2022. In practice, Class I/II filings through the Declaration of Conformity route move fastest, while Class III/IV devices undergoing conventional review typically take 60–120 working days once the dossier is complete. Deficiency rounds, wrong classification, and missing certificates are the main causes of delay.
| Phase | Typical duration | Key activities |
|---|---|---|
| Dossier preparation | 2–3 months | Document collection, translations, classification confirmation, gap analysis |
| Establishment habilitation (if new) | Up to 60 business days | ANMAT establishment authorization under Disposición 2319/2002 via GEMHA |
| Submission and completeness check | 2–4 weeks | HELENA filing; deficiency queries possible |
| Technical review (Class III/IV) | 60–120 working days | INPM evaluation, query cycles |
| Grant and PM number | 2–4 weeks | Formal ANMAT disposition; Certificado de Autorización issued |
The PM Certificado de Autorización is valid for 5 years. Renewal (reválida) is an affirmative filing obligation handled through HELENA — start the reválida filing before the certificate expires, because a late reválida can mean starting over as a new initial registration. bioaccess® confirms the expected timeline at the proposal stage based on the device's class and dossier readiness.
What does ANMAT registration cost?
ANMAT's product-registration filings are arancelado (fee-bearing), with amounts set by the agency's current arancel schedule — and the fee landscape moved in 2026, so treat older published peso tables as historical. Three cost layers matter for budgeting:
- Registration filing fee — set by ANMAT's current arancel schedule for productos médicos (national vs. imported, by class). Confirm the current figure at the proposal stage.
- Import-dispatch intervention tasa — Disposición ANMAT 5461/2026, in force September 1, 2026: 1.5% of the merchandise's FOB value (1.25% reduced rate for larger operations), capped at ARS 5 million for medical products. This is an import-clearance charge, not the registration fee.
- Annual RPPTM maintenance fee — registration holders pay a per-device annual fee to keep the device on the register, tiered by risk class.
These cover only ANMAT's charges. The real budget drivers are the dossier itself: translations into Spanish, the GMP/BPF certificate, the Argentine establishment's habilitation, samples, and the regulatory filing work. Government fees and the import tasa are the smaller part of the total — the commercial cost is the in-country regulatory work. bioaccess® provides the full Argentina titleholder + importation service as a quoted engagement — see the Argentina market access page for current commercial terms.
How does importation work once the device is registered?
Since mid-2025, import authorization runs on separate tracks by risk class under Disposición ANMAT 4446/2025 — registration is presupposed in both tracks, so an unregistered device cannot legally ship under either one:
- Class I/II (commercial or free distribution): ANMAT no longer issues a prior import authorization. The importer files a sworn Aviso de Importación through ANMAT's BONITA system within 48 hours of customs clearance.
- Class III/IV, IVDs, temporary imports, and unregistered-device samples: the standard ANMAT prior import-authorization procedure still applies.
- Direct-user imports (hospitals, non-profit institutions), any class: filed through the TAD platform.
- Only companies duly habilitado by ANMAT may import and commercialize the products, and the registration status must be current before any shipment — an expired registration blocks import either way.
As titleholder and importer of record, bioaccess® manages the BONITA filings and prior import authorizations on your behalf, so shipment-level compliance stays with the same partner that holds your PM registration.
Is there a fast track for FDA-cleared or CE-marked devices?
There is no formal fast-track program, and no foreign authorization substitutes for the Argentine PM registration — FDA clearance, CE marking, or any other approval does not replace it. But the framework is reliance-friendly in substance:
- Registration of an imported device rests on the Certificate of Free Sale plus the origin-market authorization — ANMAT does not independently re-review design verification the way a full domestic assessment would.
- Products already authorized for public consumption in a reference market are exempt from local testing: Australia, EFTA countries, EU countries, the United States, Israel, Japan, and the United Kingdom (Annex I of Decreto 892/25).
- The CFS must be issued by the competent authority of the country of origin or provenance and accredit that the product is effectively authorized and marketed there — a CFS issued within the last 24 months is the standard evidentiary anchor.
- Reference-authority marketing history (how long and where the device has been marketed) is part of the evaluation; a device with a strong FDA/CE track record presents a cleaner file than one with none.
Practical implication: manufacturers with FDA 510(k) clearance or CE marking already hold the two most valuable documents in the file — the CFS and the origin-market authorization. The remaining work is Argentine: the habilitado establishment, the HELENA filing, the Responsable Técnico, and Spanish labeling.
What happens if you import without registration?
Importing or commercializing an unregistered medical device is illegal, not a gray area. Ley 16.463 prohibits the elaboration, tenancy, fractioning, circulation, distribution, and delivery to the public of products that are impuros o ilegítimos — which includes medical devices marketed without the sanitary authorization. ANMAT's enforcement record is active and public:
- ANMAT routinely prohibits the use, commercialization, and distribution of unregistered products nationwide and opens health-summary proceedings (sumarios sanitarios) against the responsible firm — for example Disposición 8703/25 against JURATEC MEDICAL S.R.L., which had fabricated and sold devices without registration.
- Unregistered devices are seized or held at the border: customs will not clear shipments that lack the registration and the corresponding import authorization.
- Public procurement and private hospital networks require a valid PM registration in tenders — increasingly the strongest commercial driver, even where border enforcement has gaps.
- ANMAT maintains market-surveillance and technovigilance programs that flag unregistered and falsified products sold online and in clinics, with public alerts and prohibition dispositions.
**No 'ship first, register later' strategy**
Registration status must be current before any shipment. Budget registration into your launch timeline from day one — and keep the reválida calendar, because a lapsed registration is the most common way compliant companies fall out of compliance.
Frequently asked questions
Sources and basis of this article
This article is based on the Argentine regulatory framework as of October 2026: Disposición ANMAT 64/2025 incorporating Mercosur Resolución GMC 25/21 (ANMAT implementation notice, 16 January 2025); Disposición ANMAT 4446/2025 on Class I/II import simplification (ANMAT notice); Disposición ANMAT 2319/2002 (T.O. 2004) on establishment authorization; Disposición ANMAT 3266/13 on GMP/BPF; Disposición ANMAT 9688/2019 on IFU format; Disposición ANMAT 8194/2023 on tecnovigilancia; Disposición ANMAT 5461/2026 on import-dispatch fees; Ley 16.463; and ANMAT's HELENA platform for RPPTM registration dispositions (helena.anmat.gob.ar). Fee and timeline specifics come from a current industry regulatory summary (Artixio, updated September 2026) cross-checked against ANMAT notices; confirm the applicable amounts and timelines with the Argentine titleholder at the proposal stage. Regulatory analysis with Mike Legal AI (decision support, not a licensed attorney). This article is general information, not legal advice.
BA
bioaccess® · End-to-end medical device registration and market access services across the Americas, including ANMAT (Argentina), DIGEMAPS (Dominican Republic), COFEPRIS (Mexico), ANVISA (Brazil), and INVIMA (Colombia). Argentina is the market where bioaccess® provides full titleholder and importer-of-record services through its own Argentine entity.
Market Access Services
Argentina Overview
Ready to register your device with ANMAT?
Argentina is a large, sophisticated device market — but entry runs through a habilitado establishment, a HELENA filing, a designated Responsable Técnico, and a 5-year PM registration with ongoing tecnovigilancia. In every other Latin American market you would need your distributor to hold the registration. In Argentina, you don't: bioaccess® holds the PM registration and imports directly through its own Argentine entity — one accountable partner for registration, ANMAT liaison, importation, and tecnovigilancia, with no distributor-held registration risk. Start with a strategy call, or review the full service scope on our Argentina market access page.
Schedule a Strategy Call
Argentina Market Access
Related resources:
- Argentina Market Access — /market-access/argentina-anmat
- Market Access Services — /market-access
- Do non-implantable medical devices need DIGEMAPS registration in the Dominican Republic? — /blog/digemaps-medical-device-registration-dominican-republic
- COFEPRIS medical device registration in Mexico — /blog/cofepris-medical-device-registration-mexico