Medical devices sold in Argentina are regulated by ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica). ANMAT requires two separate approvals before market entry, establishment authorization for the manufacturer or importer, and product registration for the specific device by risk class.
This article covers Argentina Medical Device Classification, registration requirements, labeling, imports, fees and post-market obligations under ANMAT’s current rules.
Regulatory Authority for Medical Devices in Argentina
ANMAT is the authority responsible for medical device registration, establishment authorization, post-market vigilance and regulatory oversight in Argentina.
ANMAT does not perform every related function itself. Within ANMAT, the Instituto Nacional de Productos Médicos (INPM) handles technical evaluation. Its product registration area is what actually registers medical devices in the RPPTM (Registro de Productos Médicos y Tecnología Médica).
A separate area exists for vigilance. The Dirección de Vigilancia Post Comercialización y Acciones Reguladoras (DVPCyAR) runs it, and through the Tecnovigilancia program, it tracks adverse events and quality failures once a device reaches the market.
Once ANMAT-side authorizations, or the applicable sworn declaration, are in place, clearance itself runs through Argentina’s customs administration.
Four regulatory activities need to be kept separate when planning a Medical Device
Registration in Argentina:
- Establishment authorization, which qualifies the manufacturer, importer or distributor to operate, currently governed by Disposición ANMAT 2319/2002 (T.O. 2004) for manufacturers/importers and Disposición ANMAT 6052/13 for distributors handling interjurisdictional transit.
- Product registration, which qualifies the specific device, currently governed by Disposición ANMAT 64/2025.
- Import requirements, which apply per shipment and, since mid-2025, differ sharply by risk class.
- Post-market surveillance, an ongoing obligation once registration is granted, governed by Disposición ANMAT 8194/2023.
Argentina Medical Device Classification
Argentina places medical devices into four risk classes, Class I, II, III, and IV, based on the risk the product poses to the patient, user, or operator. Classification is assigned under Disposición ANMAT 64/2025 (incorporating Mercosur Resolución GMC 25/21).
IVD products use a separate four-tier scheme, Groups A, B, C, and D, under Disposición ANMAT 2198/2022.
| Class | General Risk Level | Registration Mechanism |
| Class I (non-sterile, non-measuring, non-active, listed in the applicable Annex) | Lowest |
Simplified mechanism by sworn statement (Declaración Jurada)
|
| Class I (all other) and Class II | Low to moderate |
Simplified mechanism by Declaration of Conformity (Declaración de Conformidad)
|
| Class III | High | Conventional mechanism, full technical evaluation |
| Class IV | Highest | Conventional mechanism, full technical evaluation |
Classification determines the registration mechanism. Class I and II devices generally register through a simplified route, either a sworn statement (Declaración Jurada) for the narrowest low-risk category or a Declaration of Conformity for other Class I/II devices. Class III and IV devices go through conventional registration, a full technical evaluation by ANMAT.
Local Representative and Importer Requirements in Argentina
Requirements differ by applicant type:
- Argentine manufacturers need establishment authorization under Disposición 2319/2002 and must register each device under Disposición 64/2025.
- Importers need their own establishment authorization and carry ongoing responsibility for imported products, including ANMAT audits.
- Distributors handling interjurisdictional transit need a separate authorization under Disposición ANMAT 6052/13, valid five years and renewable within 120 days of expiry.
- Foreign manufacturers cannot apply to ANMAT directly. An Argentine entity, generally the importer, holds the registration, keeps the dossier available for audits, communicates with ANMAT on the manufacturer’s behalf and supports ongoing regulatory compliance.
Argentina does not use the EU MDR concept of an EU Authorized Representative (EC REP). Its requirement is that manufacturing and importing establishments must be authorized under Disposición 2319/2002, which also requires registering a designated Responsable Técnico (Technical Responsible person).
Medical Device Registration Process in Argentina
Argentina’s medical device approval process runs through thirteen steps, from confirming the product’s status to post-market compliance. The sequence below reflects ANMAT’s current procedure under Disposición 64/2025.
Step 1: Confirm the product meets Argentina’s medical device definition.
Step 2: Determine the Argentine risk classification under Disposición 64/2025.
Step 3: Confirm the responsible Argentine establishment.
Decide whether the applicant is the Argentine manufacturer itself or an Argentine importer acting for a foreign manufacturer.
Step 4: Confirm establishment authorization.
The manufacturing or importing establishment needs its own authorization under Disposición 2319/2002 (T.O. 2004) before, or alongside, the product-level filing.
For Class I/II devices and IVD Groups A/B, ANMAT introduced a simplified establishment-authorization track under Disposición ANMAT 8799/2025 as an alternative to the standard procedure under Disposición 7425/13 and Disposición 2096/22.
Step 5: Prepare the technical and administrative documentation
It should match the risk class and applicant type.
Step 6: Prepare Argentina-compliant labeling and instructions for use, following the labeling annex referenced in the current registration regulation and as per Disposición ANMAT 9688/2019, drafted in the form and content required for the instructions for use.
Step 7: Prepare the registration application using the current official RPPTM forms.
Step 8: Submit the application through ANMAT’s HELENA system.
HELENA is INPM’s electronic platform for medical device registrations, in operation since 2017, and now also carries the public rule library referenced in ANMAT’s 2025 classification-transition guidance.
Related digital systems include BONITA (import management, including the Class I/II import-notice module described later in this article), GEMHA (establishment authorizations and modifications), ARGOS (adverse event and field safety corrective action reporting) and THEMIS (the sworn-declaration filing used for the simplified low-risk establishment track under Disposición 8799/2025).
Step 9: ANMAT regulatory review.
For Class I/II filings under the Declaration of Conformity mechanism, INPM reviews the sworn documentation. For Class III/IV, ANMAT carries out a full technical evaluation and may request additional information.
Step 10: Respond to ANMAT queries.
Deficiency responses affect how long the file takes to close.
Step 11: Obtain the registration.
For Class III/IV, this is a formal ANMAT disposition granting an RPPTM number (PM number). For Class I/II under the Declaration of Conformity route, the signed Declaration of Conformity is treated as proof of RPPTM registration, consistent with the simplified-mechanism structure.
Step 12: Comply with import and market-entry requirements
Since 2025 it differs materially by class.
Step 13: Maintain post-market compliance
This covers vigilance through ANMAT’s ARGOS system, adverse event reporting, recordkeeping and revalidation before the registration expires.
Not every device moves through all thirteen steps identically. The depth of Steps 5 through 9 scales directly with the risk class determined in Step 2.
ANMAT Medical Device Registration Requirements
The documentation package depends on class and registration mechanism.
For Class I/II filings, the requirements confirmed through official and near-official summaries of the current framework include:
- Registration form
- Fee payment receipt
- Declaration of Conformity
- Copy of the establishment’s authorization disposition and certificate under Disposición 2319/2002 (T.O. 2004)
- Copy of the current Good Manufacturing Practice certificate issued under Disposición ANMAT 3266/13
- For imported products, official foreign regulatory certification (such as a Certificate of Free Sale) demonstrating the product is authorized and marketed in a comparable regulatory jurisdiction
Class III and IV filings require a fuller technical file.
- Product description
- Intended use
- Design and manufacturing information
- Risk management documentation
- Verification and validation data
- Labeling matched to the current registration annex.
Not every listed document applies to every device. The applicable list depends on the specific procedure and device category and should be checked against the current disposition before a dossier is assembled.
GMP and Quality System Requirements for Medical Devices in Argentina
Manufacturing establishments need a current GMP certificate (Disposición 3266/13), valid for five years and renewed under Disposición 7425/13. Mercosur inspection rules now run under Disposición 11419/24, which replaced the older 3265/13
ISO 13485 is widely used across the industry as a supporting quality standard, but it’s not Argentina’s legal requirement. The legal requirement is the GMP certificate under Disposición 3266/13. So a company can hold ISO 13485 as good practice, useful for credibility and for other markets, but it doesn’t substitute for the GMP certificate.
ANMAT Medical Device Labeling Requirements
Labeling and instructions for use must follow the labeling annex of the current registration regulation, Disposición 64/2025. Instructions for use must be drafted in the format specified under Disposición ANMAT 9688/2019.
Labeling and instructions for use must be in Spanish. Required fields, such as the PM (product registration) number and the manufacturer or importer’s identity, must appear exactly as specified. Kits made up of individually registered products with intact original packaging don’t need a separate combined registration. But the kit’s label or IFU must still carry each component’s product information
For IVDs, labeling also follows Disposición ANMAT 2674/99.
Medical Device Registration Timeline in Argentina
No official disposition sets a guaranteed end-to-end processing period for product registration itself under Disposición 64/2025. A few adjacent procedures do have confirmed statutory clocks, useful as a reference point:
- Establishment authorization (GEMHA): 60 business days from filing to decision, under Disposición 2096/2022.
- Registration cancellation review: 20 business days once the technical report is issued, under Disposición 9688/2019.
- Simplified establishment track (8799/2025): no expiry once granted, but material changes must be reported within 30 days via a new sworn declaration.
None of these is the initial product-registration timeline itself. In practice, Class I/II Declaration of Conformity filings may take less time, while Class III/IV devices undergoing conventional review often take 60 to 120 working days. Deficiencies, incomplete documentation, wrong classification, and missing certificates all extend the practical timeline.
ANMAT Medical Device Registration Fees
Medical-device fees are currently set under Disposición ANMAT 5461/2026, effective September 1, 2026. ANMAT has not published an official fee structure for the initial product-registration filing. So manufacturers should confirm the applicable amount directly with ANMAT before filing.
Registration holders also pay an annual RPPTM maintenance fee to keep a device on the register, separate from the initial filing fee. Under Disposición ANMAT 5634/2024, this ran from ARS 39,500 for Class I to ARS 93,000 for Class IV for commercialized devices. This fee has risen sharply each year, more than tripling between the 2023 and 2024 updates, so applicants should confirm the current amount with ANMAT.
ANMAT Medical Device Import Requirements
This is the area that changed most since mid-2025. Product registration, establishment authorization, and import authorization remain separate, but the import step now runs on different tracks by class.
Under Disposición ANMAT 4446/2025, ANMAT no longer intervenes in import authorization for Class I/II devices meant for commercial or free distribution. Instead, the importer files a sworn “Aviso de Importación” through ANMAT’s BONITA system within 48 hours of customs clearance.
Shipment-level requirements by track:
- Class I/II (commercial or free distribution): sworn Aviso de Importación via BONITA, filed within 48 hours of customs clearance, no prior ANMAT authorization needed
- Class III/IV, IVDs, temporary imports and unregistered-device samples: standard ANMAT prior import-authorization procedure
- Direct-user imports (hospitals, non-profits), any class: filed via TAD
- All classes: valid foreign certification where applicable, plus standard customs documentation
Registration status must be current before any shipment, regardless of track, since an expired registration blocks import either way.
Certain lower- and moderate-risk products already authorized in a listed reference market (US, EU, UK, Japan, Australia, Israel, EFTA) can skip local testing with a valid Certificate of Free Sale (≤24 months old). But this doesn’t replace ANMAT registration.
Medical Device Post-Market Surveillance in Argentina
Post-market obligations run through ANMAT’s Tecnovigilancia system, managed digitally via ARGOS since 2023, with Good Tecnovigilancia Practices set out in Disposición ANMAT 8194/2023.
Registration holders are expected to:
- Collect information on adverse events and quality failures
- Investigate incidents and respond to ANMAT requests
- Support corrective action where a risk is identified
- Notify ANMAT of serious adverse events within 10 calendar days of becoming aware of them as per Article 6 of Disposición 8194/2023
Argentina’s system emphasizes early detection and prompt regulatory response, not a fixed reporting-timeline structure. EU-style timelines and report formats, such as PSURs, should not be assumed to apply.
Common Reasons ANMAT Medical Device Applications Get Delayed
According to our experience, common reasons for application delays are:
- Classification is finalized using the pre-2025 rule set instead of the classification rules currently in force under Disposición 64/2025
- Establishment authorization and product registration are not planned on the same timeline
- GMP or Free Sale certificates have expired or do not match the applicant on file
- Labeling in the dossier does not match the labeling on the commercial product
- Responses to ANMAT queries are delayed, extending an otherwise straightforward file
Conclusion
ANMAT Medical Device Registration involves several connected requirements such as classification, establishment authorization, technical documentation, product registration, labeling, imports and post-market surveillance. The framework changed significantly in 2025, when Disposición 64/2025 replaced the older Disposición 2318/2002 and Disposición 4446/2025 deregulated imports for Class I/II devices. Given how frequently these rules change, manufacturers and importers should confirm each requirement.
Whether you are preparing a first ANMAT filing for the Argentine market or reassessing an existing RPPTM registration against the 2025 regulatory changes, Artixio provides regulatory compliance support in Argentina to help medical device companies navigate registration and ongoing compliance requirements. Get in touch with Artixio at info@artixio.com to map a practical, ANMAT-specific registration pathway for your device.
FAQs
1. What is ANMAT Medical Device Registration?
It is the process of recording a medical device in Argentina’s RPPTM, administered by ANMAT’s Instituto Nacional de Productos Médicos, required before the device can be legally marketed in the country.
2. How do I register a medical device in Argentina?
The Argentine establishment responsible for the product, either the Argentine manufacturer or an authorized importer, files a registration application with ANMAT under Disposición 64/2025 through the HELENA system, using the mechanism (sworn statement, Declaration of Conformity, or conventional registration) that matches the device’s risk class.
3. How are medical devices classified in Argentina?
Into four risk classes, Class I, II, III and IV, under the classification rules incorporated by Disposición ANMAT 64/2025. IVDs use a separate Group A to D scheme under Disposición 2198/2022.
4. How long does ANMAT medical device registration take?
No official disposition sets a guaranteed timeline for the initial registration step itself. Adjacent procedures do have confirmed statutory clocks, such as INPM’s 60 business-day window to evaluate GEMHA establishment filings, but these don’t apply directly to product registration. Practical planning ranges run longer for Class III/IV conventional review than for Class I/II Declaration of Conformity filings and actual timing depends on documentation completeness and any ANMAT queries.
5. Can an FDA or CE approval be used for ANMAT registration?
Not as a general substitute for ANMAT’s own registration. A foreign approval or certificate ordinarily supports a dossier as evidence rather than replacing ANMAT’s registration act. Since Disposición ANMAT 236/2026, a narrower exception applies to certain lower- and moderate-risk products already authorized in specific reference markets, which can be exempted from local testing on submission of a valid Certificate of Free Sale, though the product still needs ANMAT notification and authorization.
