Argentina Sets New Rules for Foreign Device GMP Certificates

Argentina's ANMAT has published Disposición 6403/2026 in the Boletín Oficial of 6 October 2026. Signed on 1 October, it took effect on 7 October 2026, the day after publication, under Article 10.

The disposition approves two documents: new "Guidelines for the processing of Good Manufacturing Practice certificates for plants located abroad" (Annex I) and a uniform certificate model (Annex II). It applies to medical device and IVD manufacturing plants outside Argentina in cases not covered by ANMAT Disposición 3266/2013 and 11419/2024 — that is, outside the MERCOSUR inspection framework, as explained in ANMAT's announcement.

Why the certificate matters

Annex I states that ANMAT issues the certificate to comply with Article 32 of Disposición 9688/19, for use in product registration applications and post-registration changes. The annexes can be downloaded from the official gazette record linked above.

In practice, the new guidelines define how a foreign manufacturer and its Argentine importer obtain that ANMAT-issued plant certificate.

The documented route

Annex I lists the initial documentation:

1. a sworn application note from the Argentine company, with company details, CUIT, file number, the plant to be enabled, and the product categories and risk classes to be manufactured;
2. proof of payment of the fee;
3. ANMAT's enabling documentation for the Argentine importing company; and
4. a certificate of compliance with the current ISO 13485 edition, issued by a certification body accredited by a member of the International Laboratory Accreditation Cooperation (ILAC) or International Accreditation Forum (IAF) network, or an organization replacing them in the future. Evidence that the accreditation body belongs to the relevant network or successor is also required. The certificate scope must cover all applicable clauses of the current ISO 13485 edition, or a future replacement, for the devices the plant makes.

Only one certificate may be submitted per application. If the plants appear on different certificates, separate applications are needed.

Timelines, validity and recertification

A negative outcome follows a reasoned INPM report and the legal review path in Article 9. The Annex II certificate lists the product categories and risk classes and an expiry date. It also preserves routine GMP verification at any time in the circumstances provided for by the regulations.

What companies should do now

Pure Global analysis: the Argentine importer owns the application, but the foreign manufacturer's ISO 13485 certificate determines whether the file is viable. Check the certification body's accreditation and the accreditation body's ILAC/IAF or successor-network membership. Reconcile certificate scope, product categories, risk classes and plant locations before filing. Where plants appear on different certificates, budget for separate applications.

Plan against the clock-stopping rules, not the 40-day headline: an information request or a risk-based verification suspends the timeline. The disposition does not state the fee amount, so confirm the current fee with ANMAT before filing.