Disposición ANMAT 4446/2025: Import Facilitation for Class I and II Devices

1. Key takeaways

Disposición ANMAT 4446/2025 was published in the Official Gazette on June 24, 2025 and entered into force 30 days after publication. It eliminates ANMAT’s prior intervention over import applications for Class I and Class II medical devices — regardless of whether the products are destined for commercial sale or free distribution. The deregulation therefore covers both revenue-generating imports and donations, samples for goodwill programs, and similar non-commercial flows.

The substitute mechanism is simple but strict: the importing company must submit a sworn import notification (Aviso de Importación) through the remote processing platform (TAD) within 48 hours after the goods clear customs. The Disposición simultaneously covers samples used exclusively for exhibitions or commercial demonstrations, as well as raw materials used in the industries of the products covered. Note that the trigger is customs clearance, not port arrival: the 48-hour clock starts only once clearance is complete, and there is no buffer in between, so the notification step must be wired into the clearance workflow itself rather than handled as a follow-up task.

2. Legal basis

3. Expert insights

Insight 1: What was eliminated is prior intervention, not compliance obligations. Disposición 4446/2025 expressly retains the full compliance requirements under Disposición 2319/02 (T.O. 2004), 3266/13, 9688/19, 64/25 and their amendments and supplements. Establishment qualification, GMP, and product registration — none of the three obligations is reduced by a single item. Reading the elimination of prior authorization as a signal that imports no longer require compliance is a serious misinterpretation: the obligation set survives intact, only the checkpoint at which ANMAT verifies it has moved from before import to after clearance, enforced through the sworn notification and post-market oversight.

Insight 2: The 48-hour period runs from customs clearance, not from port arrival. This starting point dictates the design of internal processes: the notification must be triggered immediately once clearance is completed, with no buffer in between. Companies with high import volumes must standardize the action as a fixed step of the clearance procedure — a named responsible person, a TAD template, and a documented hand-off from the customs broker to the compliance function. Treating it as a best-effort task invites a missed deadline on the first delayed shipment.

Insight 3: The measure continues ANMAT’s broader deregulation route. The earlier Disposición 4033/2025 had already eliminated ANMAT’s intervention in the import authorization procedures for cosmetics, household cleaning products, dental oral hygiene products, disposable external-use hygiene products, vaginal hygiene products, and similar categories. Disposición 4446/2025 extends the same logic to medical devices, covering approximately 70 percent of low-risk product import volume (practical estimate). The direction of travel is consistent, so companies should expect the simplification to persist rather than treat it as a temporary experiment.

4. Practical recommendations

1. Make the import notification a fixed node of the clearance process. Write it into the clearance operations manual: within 48 hours after customs clearance is completed, the designated responsible person submits the sworn import notification through TAD.
2. Verify the qualification status of the importing entity. Only companies authorized by ANMAT can benefit from the facilitation; before importing, confirm that both the qualification of the license-holding company and the product registration are within their validity periods.
3. Check the registration certificate’s validity for every single shipment. An expired registration directly blocks import — this is the one red line that cannot be remedied after the fact, no matter how routine the shipment is.
4. Retain the notification submission receipts. The submission receipt of each sworn notification should be archived as evidence for any later inspection, since the deregulated regime relies on ex-post verification rather than ex-ante approval.

5. Verification checklist

• □ Confirmed the products are Class I/II and destined for commercial sale or free distribution
• □ The importing company holds ANMAT authorization
• □ The workflow for submitting the import notification within 48 hours after clearance is fixed
• □ A responsible person and a backup for TAD submissions have been designated
• □ The registration certificate’s validity has been checked before each shipment
• □ Submission receipts of import notifications are archived and retained

Regulatory information verified as of October 29, 2026.

Read as a whole, Disposición 4446/2025 shifts the regulatory touchpoint from before import to after clearance, and that shift changes what good compliance looks like. Under the old regime, the proof of diligence was the authorization obtained in advance; under the new regime, it is the archived trail of sworn notifications, valid registrations, and qualified importers that ANMAT can inspect after the fact. Companies that continue to invest only in pre-approval paperwork while neglecting post-clearance process discipline will find their risk has moved rather than disappeared. The 48-hour notification, the qualification check, the per-shipment validity check, and the receipt archive are the four pieces of that new diligence, and together they are lighter than the old prior-authorization burden while demanding more day-to-day consistency.

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.