Used and refurbished medical equipment for Argentina
ANMAT Disp. 224/2026 governs how used medical devices enter and are put into service in Argentina: refurbished abroad, used without need for refurbishment, and used for refurbishment in the country. It applies to clinics, hospitals, practices and laboratories importing for their own use, and to companies licensed as importers, manufacturers or refurbishers. The model must have a valid ANMAT registration. Class I and II: import notice within 48 hours of clearance. Class III and IV: prior import authorization.
- Required by
- Disp. (ANMAT) 224/2026
- Agency
- ANMAT
- Estimated timing
- Class I and II: the notice is filed within 48 hours of clearance (art. 3). Class III and IV: time for prior authorization [COMPLETAR].
- Official fee
- [COMPLETAR]
- Our fee
- Tailored quote
Why it is mandatory
A used unit is still a medical device under Law 16.463. Disp. 224/2026 sets which technical backing must accompany it so that it can be installed, used and remain in service with sanitary approval: a refurbishment certificate, a functional verification report or the importer's sworn statement.
That documentation does not end at customs. Before the equipment is put into operation, a record of correct-operation verification may be required (art. 5), and ANMAT can ask for it at any later inspection. Used goods are also excluded from the automatic recognition of certifications under Decree 892/2025 (art. 4).
What the regulation says
«Los productos médicos que cuenten con registro vigente ante la ADMINISTRACIÓN NACIONAL DE MEDICAMENTOS, ALIMENTOS Y TECNOLOGÍA MÉDICA, con exclusión de aquellos productos cuya indicación en los registros correspondientes sea la de “uso único” o “un solo uso”; (…) podrán importarse en condición de “reacondicionados en el exterior”, de “usados que, a criterio del importador, no requieran reacondicionamiento”, o de “usados sin reacondicionar para ser reacondicionados en la República Argentina”.»Unofficial translation: “Medical devices holding a current registration with the National Administration of Drugs, Food and Medical Technology, excluding those whose registration states “single use” or “one-time use”; (…) may be imported as “refurbished abroad”, as “used devices that, in the importer's judgment, do not require refurbishment”, or as “used devices not yet refurbished, to be refurbished in Argentina”.”
«(…) la autoridad sanitaria de aplicación, teniendo presente la gravedad y/o reiteración de la infracción, podrá proceder a la suspensión, inhabilitación, clausura, comiso, interdicción de autorización, matriculación, habilitación de profesionales, técnicos, locales, establecimientos o productos, en forma preventiva y por un plazo máximo de hasta NOVENTA (90) días.»Unofficial translation: “(…) the enforcing health authority, taking into account the seriousness and/or repetition of the violation, may proceed with the suspension, disqualification, closure, seizure, or prohibition of the authorization, enrollment or permit of professionals, technicians, premises, establishments or products, as a preventive measure and for a maximum period of up to NINETY (90) days.”
Rules that require it
- Disp. (ANMAT) 224/2026: Regime for importing used and refurbished medical devices. Repeals Disp. 806/2007. Official Gazette 02/02/2026, in force after 45 business days.
- Disp. (ANMAT) 2043/2019: Import authorization procedure referred to by Disp. 224/2026 for Class III and IV.
- Res. (ex MEyOySP) 909/94, Anexo II: Products excluded from import as used goods.
- Dec. 892/2025, art. 4: Excludes used and refurbished goods from automatic recognition of foreign certifications.
- Disp. (ANMAT) 5461/2026: Medical device fees, including those for used medical devices.
Products covered
Medical devices with a valid ANMAT registration may be imported as used goods, with exceptions:
- Diagnostic imaging equipment, monitors, ultrasound units, operating room and laboratory equipment, and other medical equipment with a valid registration.
- Refurbished abroad, restored to the manufacturer's original specifications.
- Used without need for refurbishment, at the importer's discretion and with technical backing.
- Used without refurbishment, to be refurbished in Argentina.
- Excluded: single-use devices and those listed in Annex II of Res. (former MEyOySP) 909/94.
- If the equipment has changes the manufacturer did not foresee, it is treated as a new product and needs its own ANMAT medical device registration.
Requirements and documents
Who can import and what backing is required (arts. 2 to 5):
- Importer: the device's user, or an establishment licensed to import, manufacture or refurbish medical devices of that risk class.
- Refurbished abroad: a refurbishment certificate from an establishment authorized by the manufacturer or meeting the rules of Australia, EFTA, the European Union, the US, Israel, Japan or the United Kingdom (Annex I).
- Used without refurbishment: the importer's sworn statement of verification before use, or a certificate of correct operation from the manufacturer, its authorized service, an Annex I health authority or an accredited body or laboratory.
- For refurbishment in Argentina: ANMAT's Good Refurbishment Practices certificate listing the model, or a contract with an importing or refurbishing company.
- Class I and II: import notice through TAD within 48 hours of clearance. Class III and IV: prior import authorization under ANMAT Disp. 2043/2019.
Official fees and timing
| Concept | Amount | Valid | Source |
|---|---|---|---|
| Import notice for a used Class I - II medical device | [COMPLETAR] | [COMPLETAR] | Disp. ANMAT 224/2026, art. 3 |
| 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) |
| Good Refurbishment Practices certificate | $ 1.021.500 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| Good Refurbishment Practices certificate, per family of Class I, II and III devices | $ 537.000 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
| Renewal of the Good Refurbishment Practices certificate | $ 914.400 | 2026 | Disp. ANMAT 5461/2026, Anexo II (vigente desde 01/09/2026) |
Official fees from ANMAT's medical device schedule for procedures started from 1 September 2026. Foreign refurbishment certificates, verification reports and technical service are not official fees: they are quoted separately.
Estimated timing
Class I and II: the notice is filed within 48 hours of clearance (art. 3). Class III and IV: time for prior authorization [COMPLETAR].
Depends on: Risk class, condition of the equipment (refurbished, used or for refurbishment) and whether the technical documentation from abroad arrives complete and legalized.
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How we handle it remotely
Pre-sale check
Before your buyer pays, we verify the model's ANMAT registration, that it is not single-use and its risk class.
Technical backing
We tell you which certificate the unit needs and who can issue it.
Authorization or notice
Prior authorization for Class III and IV; a notice ready to file on clearance for Class I and II.
Coordination with the broker
We pass the sanitary documents to the buyer's customs broker. We are not customs brokers; if needed, we refer to associated brokers.
Putting into service
We guide the operation verification record and build the equipment file for inspections.
Risks of not having it
- Single-use equipment or a model without valid registration: it cannot be imported under Disp. 224/2026.
- A Class I and II notice filed after 48 hours or with incomplete documents: a breach punishable under Law 16.463 and Decree 341/92 (art. 6).
- Putting equipment into use without the correct-operation verification record when required (art. 5).
- Changes not foreseen by the manufacturer: the unit becomes a new, unregistered product.
15+ years with Argentine agencies
We have spent more than 15 years on regulatory filings, long enough to work the old Disposition 806/2007 end to end before Disposition 224/2026 replaced it. With used medical equipment, the key check comes before purchase: a model without a current ANMAT registration, or labeled single-use, falls outside the regime. We confirm that first, then define the technical backing the unit's condition requires and whether its risk class calls for a post-import notice or prior authorization.
Frequently asked questions
Can a clinic import used equipment directly?
Yes. Disp. 224/2026 allows the device's user to import, as well as companies licensed as importers, manufacturers or refurbishers. If the equipment will be refurbished in Argentina and the clinic is not a refurbisher, it must attach an authentic copy of its contract with an importing or refurbishing company. The model must have a valid ANMAT registration.
What if the used equipment has no ANMAT registration?
It cannot enter under this regime. Disp. 224/2026 requires the medical device to have a valid ANMAT registration. If the model was never registered, it must first be registered as a medical device by a licensed holder. The same applies if the equipment has modifications the manufacturer did not foresee: it is treated as a new product.
Is prior authorization needed for used medical equipment?
It depends on the risk class. Class I and II: no prior authorization; an import notice is filed through TAD within 48 hours of clearance, with the corresponding technical documents. Class III and IV: yes, import authorization under ANMAT Disp. 2043/2019 is needed before clearance.
Who can issue the refurbishment certificate?
A refurbishing establishment authorized by the manufacturer, or one that meets the rules governing that activity in at least one of these jurisdictions: Australia, EFTA countries, the European Union, the United States, Israel, Japan or the United Kingdom. Without that certificate, the unit is treated as used without refurbishment.
Which rule replaced Disposition 806/2007?
ANMAT Disp. 224/2026, published in the Official Gazette on 2 February 2026, repealed Disp. 806/2007 and came into force 45 business days later. The main change: used Class I and II equipment no longer needs prior authorization and moved to an import notice after clearance.
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Get a tailored quote for used medical equipment
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- 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.
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