ANMAT medical device registration for foreign manufacturers
To sell an imported medical device in Argentina (disposables, instruments, electromedical equipment, implants, dental or optical supplies), two things are needed before ANMAT: a licensed company acting as importer and a registered product. It applies to distributors, importers and manufacturers. Registration is governed today by ANMAT Disp. 64/2025, which incorporated the MERCOSUR regulation (GMC Res. 25/21) and repealed Disp. 2318/2002. The level of scrutiny depends on the risk class: I, II, III or IV.
- Required by
- Disp. (ANMAT) 64/2025 (Res. GMC 25/21)
- Agency
- ANMAT
- Estimated timing
- Class I and II licensing by sworn statement: effective from submission (Disp. 8799/2025). Product registration: [COMPLETAR].
- Official fee
- $ 500.220
- Our fee
- Tailored quote
Why it is mandatory
Law 16.463 and its regulations place every medical device sold in the country under ANMAT oversight. Registration is the sanitary approval for the product to be marketed and remain on the market: clinics, health insurers and tenders require it, and ANMAT can request the technical file at any inspection.
Since 2025 the regime has been simplified for lower-risk products: Disp. 4446/2025 removed prior import authorization for Class I and II, replaced by an import notice within 48 hours of customs clearance. Control does not disappear: it moves to the market, with good practice inspections, product recalls and sanction proceedings.
What the regulation says
«El registro de todos los productos médicos incluidos en este RTM es obligatorio. Se entiende por registro al procedimiento administrativo mediante el cual cada Estado Parte autoriza la comercialización de un producto médico en su territorio nacional.»Unofficial translation: “Registration of all medical devices covered by this Mercosur Technical Regulation is mandatory. Registration means the administrative procedure by which each Member State authorizes the marketing of a medical device within its national territory.”
«Las infracciones a las normas de la presente ley y su reglamentación serán sancionadas: a) Con apercibimiento; (…) c) Con la clausura, total o parcial, temporal o definitiva, según la gravedad de la causa o reiteración de la misma, del local o establecimiento en que se hubiera cometido la infracción; (…) e) El comiso de los efectos o productos en infracción (…)»Unofficial translation: “Violations of this law and its implementing regulations shall be sanctioned: a) by warning; (…) c) by total or partial, temporary or permanent closure, depending on the seriousness of the case or its repetition, of the premises or establishment where the violation was committed; (…) e) by seizure of the goods or products in violation (…)”
Rules that require it
- Disp. (ANMAT) 64/2025: Incorporates GMC Res. 25/21 (medical device registration) and repeals Disp. 2318/2002 and 1285/2004.
- Disp. (ANMAT) 4446/2025: Removes prior import authorization for Class I and II medical devices; 48-hour import notice through TAD.
- Disp. (ANMAT) 8799/2025: Licensing by sworn statement for manufacturers and importers of Class I and II medical devices and IVD A and B. Official Gazette 28/11/2025.
- Dec. 892/2025 y Disp. (ANMAT) 236/2026: Recognition of approvals from reference countries and registration of Class I and II by sworn statement.
- Disp. (ANMAT) 5461/2026: Medical device fee schedule in force since 01/09/2026. Official Gazette 28/08/2026.
Products covered
The risk class is assigned with the classification rules of GMC Res. 25/21 (Disp. 64/2025), based on invasiveness, duration of contact and whether the device delivers energy. Covered categories:
- Dental, ophthalmic and optical medical devices.
- Electromedical and mechanical equipment, and devices that deliver energy for diagnosis or therapy.
- Anesthesia and respiratory products.
- Disposables, instruments, implants and hospital supplies.
- In vitro diagnostic devices (IVD), classified A to D, with their own registration.
- Class I and II (low and moderate risk) now have a simplified path; Class III and IV (high and maximum risk) keep full evaluation.
Requirements and documents
First the Argentine company is licensed, then each product or family is registered. Much of the file comes from you:
- Class I and II licensing (and IVD A and B): sworn statement under ANMAT Disp. 8799/2025, effective from submission, no expiry, subject to later Good Practice inspection (Disp. 3266/2013).
- Class III and IV licensing (and IVD C and D): operating authorization under Disp. 2319/2002 (consolidated 2004), 7425/2013 and 2096/2022, with warehouse and inspection.
- A professional technical director appointed before ANMAT.
- Registration file: manufacturer and importer data, Spanish labels and instructions for use, technical report, risk management and certificate of free sale from the country of origin; GMP certificate when the class requires it.
- Simplified path for Class I and II: devices sold in Australia, EFTA, the EU, the US, Israel, Japan or the UK can be registered by sworn statement with a certificate of free sale (Decree 892/2025 and Disp. 236/2026). See ANMAT market placement notice.
Official fees and timing
| Concept | Amount | Valid | Source |
|---|---|---|---|
| Registration of a Class I - II medical device family | $ 500.220 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| Registration of a Class III - IV medical device family | $ 824.985 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| Notification by sworn statement of a Class I-II medical device (Disp. 236/2026) | $ 476.400 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| Modification of a Class I - II / Class III - IV medical device | $ 234.045 / $ 563.850 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| Operating authorization for a medical device manufacturer and/or importer (includes first GMP certificate and appointment of technical director) | $ 1.880.550 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| License for a medical device and/or IVD distributor | $ 1.683.990 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| Customs clearance intervention for an imported medical device | 1,5 % del FOB (operaciones menores a $ 55.000.000); 1,25 % del FOB desde $ 55.000.000, con tope de $ 5.000.000 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
Amounts in Argentine pesos from ANMAT's official fee schedule, for procedures started from 1 September 2026. Translations, legalizations, apostilles and private testing or certification are not official fees and are quoted separately.
Estimated timing
Class I and II licensing by sworn statement: effective from submission (Disp. 8799/2025). Product registration: [COMPLETAR].
Depends on: Risk class, chosen path (traditional registration or sworn statement), quality of the technical file and any observations raised by the National Institute of Medical Devices.
Our fee is quoted in writing for your case: upload your documents below and get a tailored quote.
Already have part of the documents? Upload them and get a quote.
How we handle it remotely
Device classification
From your catalog and technical sheet we set the risk class under GMC Res. 25/21 and check the reference-country path.
Licensing the importer
If your buyer is not licensed, we prepare its sworn statement or operating authorization and the technical director appointment.
Manufacturer documents
We tell you exactly what to provide and check translations and legalizations before filing.
Filing and follow-up
We file on ANMAT's platform and answer observations until the certificate is issued.
Maintenance
We track renewals, label or manufacturer changes and the 48-hour notice for each Class I and II shipment.
Risks of not having it
- Selling a medical device without registration or through an unlicensed company: proceedings and sanctions under Law 16.463 and Decree 341/92, plus preventive measures such as a ban on use and market withdrawal.
- Failing to file the import notice within 48 hours of clearance for Class I and II goods (Disp. 4446/2025).
- A Good Practice inspection with findings on storage, traceability or documents: suspension of the license.
15+ years with Argentine agencies
For more than 15 years we have filed medical device registrations with ANMAT, through the shift from Disposition 2318/2002 to the Mercosur regulation adopted by Disposition 64/2025. Files usually stall on risk classification and on the manufacturer's authorization letter. Before filing, we check the classification rule applied, the validity and legalization of every certificate, and that labels, instructions for use and the technical report tell the same story.
Frequently asked questions
Is Disposition 2318/2002 still in force?
No. ANMAT Disp. 64/2025 incorporated GMC Res. 25/21, the new MERCOSUR technical regulation for medical device registration, and repealed Disp. 2318/2002 and 1285/2004. ANMAT applies it to initial registrations since 21 January 2025. If a device changes class under the new rules, the adjustment is made at renewal.
Is ANMAT authorization needed for every shipment?
For Class I and II, no: since Disp. 4446/2025 an import notice filed as a sworn statement through TAD within 48 hours of clearance is enough. The importing company must be licensed and the device registered. For Class III and IV, ask us about the current procedure for your operation before shipping.
Can an FDA-cleared or CE-marked device be registered without repeating tests?
Yes, for Class I and II. Decree 892/2025 and Disp. 236/2026 allow registration by sworn statement with a certificate of free sale from the authority of Australia, EFTA, the European Union, the US, Israel, Japan or the United Kingdom, issued no more than 24 months earlier. No local testing is required. Class III and IV still follow traditional registration.
How much does ANMAT medical device registration cost?
The official fee in force since 1 September 2026 is ARS 500,220 per Class I-II family and ARS 824,985 per Class III-IV family (ANMAT Disp. 5461/2026). Notification by sworn statement for Class I-II costs ARS 476,400. Private costs for translation, legalization and technical documentation come on top and are not fees.
Can the foreign manufacturer register the device itself?
Not directly. The registration holder must be a legal entity licensed in Argentina as manufacturer or importer, so many manufacturers work with a local importer or licensed distributor named as holder. Decide who will hold the registration before signing any exclusivity agreement.
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Get a tailored quote for medical device registration
If you already have experience and want a competitive quote to compare, or to optimize costs and timing, send us your background documents and we quote with priority.
- 1Upload your documents and tell us about the product.
- 2We review them against the regulation that applies.
- 3You receive a written quote and, if something is missing, the exact list.
- 15+ years with Argentine agencies
- Fully remote, nationwide
- Official fees published with source
- Reply within 6 hours
- Experience with every agency
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