Disposición ANMAT 64/2025: The New Principal Registration Regulation

1. Key takeaways

The principal regulation for medical device registration in Argentina has been replaced. The current principal regulation is Disposición ANMAT 64/2025 (signed January 4, 2025 and published in the Official Gazette on January 13, 2025), and it accomplishes two things: it incorporates MERCOSUR GMC/RES 25/21 into Argentine domestic law as a whole, and it expressly repeals Disposición ANMAT 2318/2002 and Disposición ANMAT 1285/2004.

The most direct consequence for companies is that the master templates for classification rules, registration procedures, document requirements and labeling requirements have all been replaced by GMC 25/21 and its Annexes I–V. Technical documentation prepared under the 2318/02 framework carries a systematic risk of rework under the new framework, because the underlying requirements — the rules used to argue classification, the exact content of the technical report, the elements expected on the label — are no longer the ones the old dossier was built against.

Companies holding certificates issued under the previous framework should therefore treat the transition not as a formality but as a portfolio-wide review exercise: every existing certificate now rests on a legal foundation that has been formally repealed, and the argument for continued validity must be rebuilt on the new instruments.

2. Legal basis

The table below lists the new principal regulation, the MERCOSUR technical regulation it incorporates, and the instruments that were repealed in the process, so the before-and-after of the framework can be read in one place.

3. Expert insights

Insight one: this was not a technical upgrade initiated by ANMAT, but the fulfillment of a binding regional obligation. Under the 1994 Protocol of Ouro Preto, technical regulations approved by the MERCOSUR common market must be incorporated in full into the domestic legal systems of the member states. After GMC 25/21 was adopted in Montevideo on October 13, 2021, Argentina’s former 2318/02 and 1285/04 — being based on the old GMC 40/00 — had to be repealed in step as a matter of law. Argentina was among the first parties to complete the transposition, which means its current practice is the most mature available reference for the region.

Insight two: the entry-into-force mechanism differs from other markets and follows regional synchronized entry into force. Under the Ouro Preto synchronization mechanism, GMC 25/21 enters into force uniformly once all member states have completed incorporation into domestic law. This means Argentina has completed its transposition and ANMAT’s current published position is applied under 64/2025, while the formal regional entry-into-force date depends on a unified notification from the secretariat. Companies planning across multiple countries cannot assume the four states share a single timetable, even though the underlying text is identical.

Insight three: the actual workload created by the changeover concentrates in two places — classification and labeling. Classification moves from the old system to the 22 rules of Annex II of GMC 25/21; labeling requirements move from Annex III.B of 2318/02 to Annex IV of GMC 25/21. The remaining procedural requirements have been adjusted, but continuity is strong overall. A review of existing certificates should therefore prioritize these two items before anything else.

4. Practical recommendations

1. Immediately stop using 2318/02 as the basis for document preparation. Any internal template, technical report format or label draft that references 2318/02 should be redone against the annex formats of GMC 25/21 without exception.
2. Run a master-template fitness check on dossiers still under review. For applications submitted before January 13, 2025 and still in review, proactively verify whether the classification justification and labeling have been prepared under the new rules, and submit a supplementary explanation where necessary.
3. Re-verify classification for certified products. Focus on three categories — software-containing products, drug-containing components and nanomaterials — because these three have dedicated rules in GMC 25/21 and their old classification conclusions carry the highest probability of being invalidated.
4. Monitor the MERCOSUR secretariat’s entry-into-force notification in parallel; for companies already established in Brazil, Paraguay or Uruguay, Argentina’s transposition text can serve as rehearsal material for filings in the other three states.

5. Verification checklist

• □ Confirmed that the current principal regulation is Disposición ANMAT 64/2025, published January 13, 2025
• □ Confirmed that 2318/2002 and 1285/2004 have been expressly repealed
• □ Confirmed that GMC/RES 25/21 was adopted on October 13, 2021 and replaced GMC 40/00
• □ Internal templates have been replaced from 2318/02 to the annex formats of GMC 25/21
• □ Dossiers under review have completed the fitness check on classification justification and labeling
• □ A tracking mechanism for the regional entry-into-force notification has been established

Regulatory information verified as of October 29, 2026.

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

The GRZAN regulatory team consists of professionals with many years of hands-on international registration experience and continuously tracks the developments of regulatory authorities worldwide; all published content follows the editorial standard of conclusions first, traceable bases and verifiable figures. For a tailored market access plan for Argentina or the MERCOSUR region covering a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.