Argentina medical device regulations
Official sources linkedANMAT rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
15 documents4 categories100% linked to official sourcesauthority ANMAT15 readable HTML
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Disposición 236/2026 | Sworn Notification for Imported Low- and Moderate-Risk Devices and IVDs Implements Decreto 892/2025. Imported Class I/II devices and IVD classes A/B without cold chain may enter through a prior sworn notification that recognizes foreign regulatory equivalence. | Registration | February 6, 2026 | Official |
| Disposición 8799/2025 | Simplified Establishment Authorization for Low-Risk Devices and IVDs Simplified sworn-statement pathway for manufacturing or import authorization of Class I/II medical devices and IVD classes A/B. | Registration | November 28, 2025 | Official |
| Disposición 4446/2025 | Import Notification for Class I and II Medical Devices Removes prior ANMAT import authorization for registered Class I/II devices. Importers file a sworn notification within 48 hours of nationalization. | Registration | August 6, 2025 | Official |
| Disposición 2565/2025 | Reduced Shelf Life Requirements for Imported Devices Reduces minimum shelf life required for imported medical devices from one year to six months. Replaces Disposición 1655/1999. | Registration | April 15, 2025 | Official |
| Disposición 64/2025 | Mercosur Technical Regulation for Medical Device Registration (Current) Current Mercosur registration and classification regulation. Incorporates GMC Resolution 25/21 and repeals Disposición 2318/2002 and 1285/2004. | Registration | January 21, 2025 | Official |
| Disposición 11467/2024 | Essential Safety and Performance Requirements (Current) Incorporates Mercosur GMC Resolution 07/24 on essential safety and performance requirements for medical devices and IVDs. Repeals Disposición 4306/99. | General | January 2, 2025 | Official |
| Disposición 8194/2023 | Good Technovigilance Practices Post-market technovigilance duties for registration holders, including adverse-event and quality-failure definitions, reporting, and field safety actions. | Vigilance | September 28, 2023 | Official |
| Disposición 2198/2022 | IVD Registration, Classification and Modifications (Current) Current IVD registration, modification, revalidation, transfer, and cancellation procedure. Introduces IMDRF/Mercosur Groups A–D classification and updates Disposición 2674/99. | Registration | June 2022 | Official |
| Disposición 9688/2019 | Medical Device Registration Requirements (Current) Current regulation for medical device registration in Argentina. Replaced Disposición 727/2013 and 5706/17. Establishes labeling and registration requirements. | Registration | December 2019 | Official |
| Disposición 3266/2013 | Good Manufacturing Practices for Medical Devices (Mercosur) Adopts Mercosur GMC Resolution 20/11 for GMP. Replaced older GMP dispositions (191/99, 698/99). Current GMP requirements for medical devices. | GMP/QMS | June 2013 | Official |
| Disposición 2318/2002 | Mercosur Technical Regulation for Medical Device Registration Former core regulation adopting Mercosur GMC Resolution 40/00 for Class I–IV registration. Replaced by Disposición 64/2025, which incorporates GMC Resolution 25/21. | Registration | May 9, 2002 | Official |
| Disposición 2319/2002 | Manufacturing and Import Authorization Requirements Governs manufacturing and import authorizations for medical devices. The published official text is the 2004 texto ordenado (Disposición 3433/2004) of Disposición 2319/2002. | Registration | May 9, 2002 | Official |
| Disposición 4306/99 | Essential Safety and Effectiveness Requirements Former essential safety and effectiveness requirements for medical devices. Replaced by Disposición 11467/2024, which incorporates Mercosur GMC Resolution 07/24. | General | August 1999 | Official |
| Disposición 2674/99 | Registration of In Vitro Diagnostic Products Original IVD registration framework. Article 1 and remaining annexes still apply as updated by Disposición 2198/2022, which replaced the classification annexes and current filing procedure. | Registration | June 2, 1999 | Official |
| Disposición 224/2026 | Import of Used and Refurbished Medical Devices Current rules for importing refurbished or used medical devices, including functioning certificates and local verification. Repeals Disposición 806/2007. | Registration | 45 business days after February 2, 2026 | Official |
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Tracked from official ANMAT publications · row IDs are stable — cite as regulations:argentina:disp-2318-2002