When ANMAT Prior Import Authorization Is Still Required in Argentina

1. Key takeaways

Disposición 4446/2025 opened up prior import authorization only for Class I/II devices. For every scenario listed below, ANMAT prior authorization is still required:

One red line admits no exceptions: at the time of every single import shipment, the registration certificate must be within its validity period — the registration is valid for 5 years, and an expired registration directly blocks the import. This applies regardless of device class, regardless of pathway, and regardless of whether the shipment is commercial, donated, or demonstrative.

2. Legal basis

3. Expert insights

Insight 1: IVDs still require prior authorization across the board, and this is routinely misjudged. The scope of Disposición 4446/2025 is Class I/II medical devices; IVDs are not included. Even Group A/B low-risk IVDs still require prior authorization at the import stage. Applying the facilitation rules for devices to IVD products is one of the most frequent operational errors in practice, and it surfaces exactly at customs, where a shipment cleared under the wrong assumption can be stopped, delayed, or refused — costs that dwarf the planning effort that would have avoided the mistake.

Insight 2: The notification regime of 236/2026 and the import notification of 4446/2025 operate at two different levels. The former resolves the question of eligibility — whether a product may be imported and commercialized in the country — through a prior sworn notification. The latter resolves a procedural question — whether each individual shipment requires ANMAT approval shipment by shipment. The two apply cumulatively and cannot substitute for each other: a product cleared under the eligibility regime still follows the shipment-level pathway that its class dictates.

Insight 3: Registration validity is an absolute precondition at the import stage. Whichever pathway applies, an expired registration blocks the import. The practical meaning is that renewal scheduling must precede import planning: a company cannot wait until the certificate is close to expiry to start the renewal, because the renewal timeline and the shipment timeline will eventually collide, and the collision always costs more than the early filing would have.

4. Practical recommendations

1. Triage pathways with a two-dimensional table: product category × import purpose. First determine the category (devices Class I/II, devices Class III/IV, IVD, samples, temporary), then the purpose (commercial, free distribution, exhibition or demonstration, hospital self-use), and derive the pathway from the combination.
2. Reserve approval time for scenarios requiring prior authorization. Import approvals for Class III/IV devices, IVDs, and samples must be built into logistics schedules; they cannot be estimated on a clearance-and-release basis.
3. Maintain a linked dashboard of registration validity and import plans. Start the renewal 12 months before certificate expiry so that the import chain never has a gap between shipments.
4. Route hospital direct-purchase orders separately through TAD. Imports by direct users are submitted through TAD and should be managed as a distinct workflow from the commercial imports of the license-holding company.

5. Verification checklist

• □ The import pathway for each product type confirmed against the two-dimensional table
• □ Prior authorizations scheduled for Class III/IV devices, IVDs, temporary imports, and unregistered samples
• □ Imports by direct users such as hospitals confirmed to be submitted through TAD
• □ A linked dashboard of registration validity and import plans is in place
• □ The registration certificate’s validity checked before every shipment
• □ The cumulative application of the 236/2026 notification regime and the 4446/2025 import notification confirmed

Regulatory information verified as of October 29, 2026.

The value of the two-dimensional triage is that it makes the pathway decision a lookup rather than a judgment call made under time pressure at the customs stage. Each axis carries only a handful of values — five categories and four purposes — so the table stays small enough to memorize, yet it prevents the two most expensive confusions: applying the facilitation rules of 4446/2025 to IVDs, and assuming that temporary imports or unregistered samples inherit any relaxation at all. Combined with the linked dashboard that ties renewal timing to shipment planning, the triage table turns the scattered rules of 4446/2025, 236/2026, 224/2026, and 64/2025 into one operating procedure that logistics, regulatory, and commercial teams can all read the same way.

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.