Reference Countries and the Free Sale Certificate Route

1. Key takeaways

The reference countries and regions listed in Annex I of Decreto 892/2025 are: Australia, the United States, Israel, Japan, the United Kingdom, the member states of the European Union, and the member states of the European Free Trade Association (EFTA).

With a free sale certificate (CFS) issued by the competent authority of a reference country, and with a validity of no more than 24 months, the product is exempt from Argentine local testing. Where no such certificate can be provided, a certificate or test report issued by a recognized certification body or by a laboratory accredited by the Argentine accreditation body may be substituted. Where even that is unavailable, the product must complete ANMAT registration under the technical requirements in force for its product category — the fallback that applies to everyone else.

Two features of this list deserve attention. It is geographic and institutional: what matters is not where the product was approved in a general sense, but that the approving authority belongs to a listed jurisdiction and issues the certificate itself. And it operates as a closed gate for the local-testing exemption: certificates from authorities outside the list do not trigger the exemption, no matter how rigorous the issuing system may be, and the product then falls to the substitution routes or to the conventional registration pathway.

2. Legal basis

The instruments below define the reference-country list, the CFS validity condition, the exemption from local testing, and the substitution routes.

3. Expert insights

Insight 1: the 24-month limit is stricter than the conventional registration route. Article 6 of Part III of GMC 25/21 provides that a registration certificate or free sale certificate that does not state a validity period is valid for 2 years from issuance; by contrast, the 236/2026 channel requires the CFS validity to be no more than 24 months — an explicit cap rather than a default rule. When a certificate approaches expiry it must be reissued to preserve the qualification for the channel.

Insight 2: China is not on the list. An apostille processed on the basis of an NMPA Medical Device Product Export Sales Certificate can serve as a supporting document in the conventional registration route, but it is not a reference-country CFS and cannot trigger the exemption from local testing. This is the first fact to confirm when planning around the 236/2026 channel.

Insight 3: second and third-order substitution routes exist. Without a reference-country CFS, a certificate from a recognized certification body or a test report from a laboratory accredited by the Argentine accreditation body may be used; failing that, the application falls back to the conventional registration route. The cost and timeline differences among the three routes are substantial, so they should be evaluated in the order: reference-country CFS → recognized-body certificate → conventional registration.

The substitution routes give every product a path to the market, but the paths differ sharply in cost, timeline and evidentiary weight, so route selection should be a deliberate portfolio decision rather than a reaction to whichever certificate happens to be available at the moment. The recommendations below follow the priority order of the routes themselves, from reference-country CFS down to the conventional fallback.

4. Practical recommendations

1. Inventory the global approval footprint first. If the product already holds marketing authorization in the European Union, the United States, the United Kingdom, Japan, Australia, Israel or any EFTA jurisdiction, prioritize that market as the basis for the CFS application.
2. Put CFS validity into the renewal calendar. Start reissuance at least 3 months before certificate expiry so that qualification for the channel never lapses.
3. Do not skip any of the three legalization steps. Issuance by the competent authority → apostille or consular legalization → certified Spanish translation; missing any one step is grounds for rejection.
4. Plan products without reference-country approvals directly on the conventional route. Do not file a declaration to chase the channel with insufficient evidence — liability for a false declaration falls on the signer.

5. Verification checklist

Confirm each item below before relying on a CFS for the local-testing exemption.

• □ Whether the product holds marketing authorization from a reference-country authority has been checked
• □ The CFS issuing authority falls within the Annex I list of Decreto 892/2025
• □ The CFS validity is no more than 24 months
• □ The apostille or consular legalization has been completed
• □ The Spanish translation is by a certified official or sworn translator
• □ Products without reference-country approvals have been scheduled on the conventional registration route

Run this checklist per product and per market combination, since a single product line may qualify through one reference jurisdiction and not another. The output is a route map showing which products can use the local-testing exemption immediately, which need a substitution route, and which must be planned from the start on the conventional registration pathway.

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 handling classification assessment, pathway selection, GMP and CFS documentation chains, Spanish-language technical documentation and labeling 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 developments of regulatory authorities worldwide. All published content follows the drafting standard of conclusions first, traceable legal basis, 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.