Disposición ANMAT 224/2026: Used and Refurbished Device Import Framework

1. Key takeaways

Disposición ANMAT 224/2026, published on February 2, 2026, establishes a new import framework for used and refurbished medical devices. Its core move is to repeal Disposición 806/2007 and abolish the certificate for the import of used goods (CIBU). The CIBU had functioned as an additional pre-approval gate for every used-equipment shipment, and its removal removes an entire layer of front-end administration from the import chain.

The framework covers three import scenarios: ① import after refurbishment abroad; ② import of used equipment that requires no mandatory refurbishment; ③ import into Argentina followed by refurbishment within the country. The circle of eligible importers widens at the same time — end users such as clinics and hospitals may now act as importers, no longer restricted to authorized companies. Widening who may import while keeping the evidence and authorization requirements intact is the defining trade-off of the new regime, and both halves of it must be understood before any used-equipment shipment is planned.

2. Legal basis

3. Expert insights

Insight 1: Abolishing the CIBU is a substantive reduction of administrative burden. Previously, used-equipment imports required obtaining the CIBU first — an additional front-end approval before any shipment could move. With the certificate abolished by Disposición 224/2026, Class I/II used equipment proceeds under the 48-hour notification after customs clearance, aligning the treatment of used devices with the facilitation rules already applying to new devices of the same classes. The alignment matters operationally: teams can reuse the same notification workflow, templates, and responsible-person structure they built for new-product imports.

Insight 2: The three scenarios carry three evidence requirements, but one set of common obligations. Whichever scenario applies, the importer must provide: a refurbishment certificate issued by the original manufacturer (or an equivalent attestation), a remaining useful life assessment, and evidence of conformity with current safety and performance standards, together with a specific label marking the refurbished status. The evidence requirements are not lowered because the procedure is simplified. The simplification removes a paperwork gate; it does not dilute the technical standard the equipment itself must meet on arrival.

Insight 3: Risk classification still determines the intensity of approval. Class I/II devices follow the 48-hour notification after customs clearance; Class III/IV devices require ANMAT prior authorization. This matches the triage logic for new-product imports exactly, showing that 224/2026 is a subtraction performed within the existing risk-classification framework rather than the construction of a parallel regime. A company that already understands the new-device pathways needs to learn only the refurbishment-specific evidence layer, not a new approval architecture.

4. Practical recommendations

1. First determine which of the three scenarios applies. Import after refurbishment abroad, used equipment requiring no mandatory refurbishment, and refurbishment within Argentina each carry different evidence requirements — characterize the case first, then assemble the dossier.
2. Prioritize obtaining the refurbishment certificate from the original manufacturer. Where the original manufacturer cannot issue one, prepare an equivalent attestation and document its source and basis so the equivalence can be defended in an inspection.
3. Quantify the remaining useful life assessment. State the equipment’s remaining years of use or number of cycles in a verifiable way, and describe the assessment method used to arrive at the figure.
4. Reserve prior-authorization time for Class III/IV equipment. The import approval of high-risk used equipment must be built into logistics schedules; it cannot be estimated on a clearance-and-release basis.

5. Verification checklist

• □ Confirmed the framework of 224/2026 applies and the equipment is not an excluded item
• □ Determined which of the three import scenarios the case falls into
• □ Refurbishment certificate from the original manufacturer (or equivalent attestation) obtained
• □ Remaining useful life assessment quantified with its method documented
• □ Evidence of conformity with current safety and performance standards assembled
• □ Specific label marking the refurbished status designed and applied
• □ 48-hour notification (Class I/II) or prior authorization (Class III/IV) scheduled by class

Regulatory information verified as of October 29, 2026.

A practical note on sequencing: the three scenarios are not interchangeable labels, and misclassification is expensive to correct after documents have been commissioned. Import after refurbishment abroad puts the evidentiary weight on the original manufacturer’s certificate and the state of the equipment at export; used equipment without mandatory refurbishment leans on the remaining useful life assessment; refurbishment inside Argentina adds the domestic authorization question for whoever performs the work. Because GMC/RES 25/21 leaves used and refurbished equipment outside its scope of application, there is no regional harmonization to fall back on — the Argentine national framework of 224/2026 is the entire rulebook. Teams new to the market should therefore budget review time for the evidence layer, not only for the notification or authorization step that follows it.

In Argentina, GRZAN operates a wholly-owned subsidiary that can serve as the registration holder and importer for foreign manufacturers, directly handling classification determination, pathway selection, GMP and CFS documentation chains, Spanish-language technical documentation and label localization, HELENA submissions and deficiency responses, as well as BONITA import notifications, ARGOS vigilance system operation, change maintenance, and 5-year renewal planning.

The GRZAN regulatory team consists of professionals with many years of hands-on international registration experience and tracks the dynamics of regulatory authorities across countries on an ongoing basis. All external content follows the drafting standard of conclusions first, traceable bases, and verifiable figures. For an Argentina or MERCOSUR market access plan tailored to a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.