Argentina Introduces New GMP Certificate Rules for Foreign Manufacturing Sites from October 2026: ISO 13485 Recognized, 40-Working-Day Initial Assessment

Argentina Introduces New GMP Certificate Rules for Foreign Manufacturing Sites from October 2026

On 6 October 2026, Argentina's National Administration of Medicines, Food and Medical Technology (ANMAT) published Disposición 6403/2026 in the Official Gazette. The measure was signed on 1 October 2026 and, under Article 10, took effect the day after publication, namely 7 October 2026.

The rule addresses one core issue: how GMP certificates for foreign manufacturing sites are to be processed. It approves two annexes: an application guide (Anexo I) and a unified certificate template (Anexo II). The certificate will be used in product registration applications and post-registration changes, pursuant to Article 32 of Disposición 9688/19. The GMP certificate therefore becomes a gateway document for registration files.

Scope: foreign sites outside the MERCOSUR inspection framework

The scope is clearly limited. The rule covers only foreign manufacturing sites for medical devices and in vitro diagnostic products that fall outside the MERCOSUR inspection mechanism, that is, situations not covered by Disposición 3266/13 and Disposición 11419/2024. Manufacturing sites located in MERCOSUR member states continue to follow the existing inspection arrangements. Manufacturing sites in other regions must submit applications under the new requirements from 7 October 2026.

Compliance basis: current ISO 13485 certification plus accreditation-chain evidence

The compliance basis is consolidated around ISO 13485. Applicants must submit a current ISO 13485 certificate issued by a certification body accredited by an ILAC or IAF member. Submitting the certificate alone is not sufficient: the applicant must also provide evidence demonstrating that the accrediting body belongs to the ILAC/IAF network. The certificate scope must cover all applicable ISO 13485 clauses for the devices manufactured at the site. One licensing application corresponds to one certificate; if manufacturing sites are covered by different certificates, separate applications must be submitted.

Application dossier contents

The documentation requirements are also specified. The application letter is treated as a sworn declaration and must state the applicant's name, full address, CUIT, case file number, name and address of the manufacturing site to be licensed, and product category and risk level. The dossier must also include proof of fee payment and the ANMAT authorization document issued to the importer. If the product category or risk level changes, a new application is required.

Product categories and risk levels

Risk levels are not discretionary. Anexo I lists twelve product categories, from in vitro diagnostics, active implantables and non-active implantables to dental, ophthalmic and optical products, energy-emitting devices, anaesthesia and respiratory devices, medical electrical and mechanical devices, reusable instruments, single-use devices, assistive devices for persons with disabilities, and hospital equipment. Each category must be accompanied by the corresponding risk level. The certificate template likewise marks each item by the same category and risk level.

Assessment timeline and decision paths

The main text sets out the process and timeline. The National Institute of Medical Devices (INPM) has 40 working days to assess the initial dossier. After assessment, there are three possible outcomes: direct issuance of the certificate, a request for supplementary information, or a requirement for remote assessment or on-site inspection based on risk. In the latter two cases, the timeline is suspended. The certificate is issued by the INPM National Directorate, and its validity period is determined by risk assessment and aligned with the certificate submitted at the time of the licensing application. Recertification may be applied for 60 working days before expiry. If an existing certificate needs to add a product category, a separate scope-extension application is required. Cases already in process before the rule took effect must follow the new requirements and new template.

Adverse decisions follow a formal procedure

Article 9 provides a procedure for adverse outcomes. If the assessment result is negative, the INPM National Directorate issues a reasoned report and, together with a draft administrative decision proposing rejection, forwards it to the legal affairs department for an opinion before submission to the ANMAT Administrator for signature. This means a rejection is not an informal response at the counter.

Key compliance points to note

One point is easy to overlook: obtaining this certificate only confirms that the manufacturing site's GMP compliance has been recognized. The product itself must still be registered separately. The ISO 13485 certificate is one item of the application dossier and does not replace ANMAT's review of the product. The text also does not set a uniform fixed number of years for validity; the period follows the risk analysis, and the expiry date on the certificate is the actual binding constraint.

AIMEILI Regulatory Interpretation

Disposición 6403/2026 formalizes the GMP certificate as an entry-level document for ANMAT product registration and post-registration changes involving foreign manufacturing sites outside the MERCOSUR inspection framework. The practical shift is that ANMAT now expects a current ISO 13485 certificate from an ILAC/IAF-accredited certification body, supported by accreditation-chain evidence, rather than accepting a certificate without proof of the accreditation pathway. The scope of the ISO 13485 certificate must match the manufacturing site and the applicable clauses for the devices concerned.

The 40-working-day initial assessment period provides greater predictability for planning, but applicants should not treat it as a guaranteed total approval timeline. The clock pauses when INPM requests supplementary information or decides that a remote assessment or on-site inspection is needed based on risk. Certificate validity is risk-based rather than fixed, so lifecycle planning should rely on the expiry date stated on the certificate and on the 60-working-day pre-expiry recertification window.

Business impact for manufacturers, distributors and regulatory teams

• Registration sequencing: Foreign manufacturers outside MERCOSUR should confirm that the GMP certificate application is built into the product registration timeline. The GMP certificate is a gateway document, but product registration remains a separate ANMAT review.
• Certificate scoping: Manufacturers with multiple sites or multiple ISO 13485 certificates should map each manufacturing site to the relevant certificate and prepare separate GMP certificate applications where required. Adding a product category to an existing certificate requires a separate scope-extension application.
• Accreditation evidence: Regulatory teams should obtain and retain documentation showing that the ISO 13485 certification body is accredited by an ILAC or IAF member, and that the accreditation body is part of the ILAC/IAF network. This evidence should be ready before submission.
• Risk-level classification: Applicants must align the product category and risk level with the twelve categories in Anexo I. Changes to product category or risk level trigger a new application.
• Distributor and importer coordination: The dossier requires the ANMAT authorization document issued to the importer and proof of fee payment. Importers and local representatives should be engaged early to avoid documentation delays.
• Renewal and change control: Because validity is risk-based, companies should track certificate expiry dates and plan recertification at least 60 working days before expiry. Post-registration changes requiring a GMP certificate should be assessed against the new template and requirements.

Recommended actions

• Confirm whether each manufacturing site falls outside the MERCOSUR inspection mechanism and is therefore subject to Disposición 6403/2026.
• Verify that the current ISO 13485 certificate covers the relevant manufacturing site and all applicable clauses for the devices to be registered.
• Prepare accreditation-chain evidence from the certification body and accrediting body.
• Review the application letter against the sworn-declaration requirements, including CUIT, case file number, site details, product category and risk level.
• Build the 40-working-day initial assessment period and potential suspension into regulatory timelines, and monitor the certificate expiry date for recertification planning.

Sources and verification

• Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) — Disposición 6403/2026, InfoLeg full text, published 6 October 2026: https://www.argentina.gob.ar/normativa/nacional/norma-430928/texto
• ANMAT — ANMAT establece nuevos lineamientos para la tramitación de certificados de Buenas Prácticas de Fabricación (BPF) en el exterior, 6 October 2026: https://www.argentina.gob.ar/noticias/anmat-establece-nuevos-lineamientos-para-la-tramitacion-de-certificados-de-buenas-practicas
• Boletín Oficial de la República Argentina — Disposición 6403/2026, notice No. 348575, 6 October 2026: https://www.boletinoficial.gob.ar/detalleAviso/primera/348575/20261006

The above sources were checked on 24 October 2026 against the InfoLeg full text and the ANMAT press release, including the publication date, effective-date provision, procedures under Articles 3 to 6 and Article 9, the Anexo I documentation list and the ISO 13485 accreditation requirements. The Official Gazette page timed out on the access date; the issue number 36.007, page 73 and publication date are based on the InfoLeg page record. This article is an interpretation of publicly available Argentine regulatory materials and does not constitute a conclusion or commitment regarding any specific product, company or registration application. Certificate documentation, timelines and validity periods are subject to the original ANMAT text and subsequent updates.