The Crosswalk

    ANMAT

    Flag of ArgentinaArgentina — ANMAT

    GuidanceLast updated · 2023Verified · 2026-05-28

    Disposición 2318/02 + ANMAT cybersecurity criteria

    Authority

    Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

    Enforced

    2002 (rev. 2022)

    Legal framework

    Ley 16.463 + Disposición 2318/02 + PDPA Argentina (Ley 25.326)

    FDA package reuse

    ~85%

    Scope

    All medical devices marketed in Argentina, with SaMD and software updates increasingly under scrutiny.

    Pre-market

    Risk-class registration dossier; reference-jurisdiction route accepts FDA / CE / Health Canada approvals.

    Post-market

    Tecnovigilancia reporting to ANMAT, software change notifications.

    SBOM

    Recommended

    Encouraged in line with IMDRF N60; not yet mandated.

    Vulnerability disclosure

    Encouraged via CERT.ar coordination.

    Penalty

    Registration cancellation, sanitary fines, criminal liability for adulteration.

    Unique requirements

    • 01Argentine Registration Holder
    • 02Spanish-language IFU and labelling
    • 03Mercosur GMP audit accepted

    Highlights

    • Reference jurisdiction route shortens timelines
    • Spanish-language documentation throughout
    • Mercosur harmonisation increasing

    Aligns with

    IMDRF N60 Mercosur GMP ISO 13485

    Timeline

    1. 2002

      Disposición 2318/02 published

    2. 2022

      Cybersecurity criteria added in revision

    Key documents

    Related markets

    Frequently asked about Argentina

    Is SBOM required for medical devices in Argentina?

    Recommended. Encouraged in line with IMDRF N60; not yet mandated.

    What does ANMAT require for pre-market cybersecurity?

    Risk-class registration dossier; reference-jurisdiction route accepts FDA / CE / Health Canada approvals.

    What are the post-market cybersecurity obligations under ANMAT?

    Tecnovigilancia reporting to ANMAT, software change notifications.

    What is the penalty for non-compliance with ANMAT cybersecurity rules?

    Registration cancellation, sanitary fines, criminal liability for adulteration.

    How much of my FDA cybersecurity package is reusable in Argentina?

    Roughly 85% — an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).