ANMAT Simplified Authorization Regime for Medical Device Manufacturers and Importers

Argentina’s ANMAT has introduced a simplified authorization regime under Provision No. 8799/2025 for establishments manufacturing or importing low-risk medical devices, including Class I and II devices and Class A and B IVDs.

The new framework enables companies to apply through the Themis digital platform, using a streamlined process that includes submitting a sworn declaration (DDJJ) for compliance. Required documentation includes facility details, municipal and environmental approvals, technical management, and adherence to Good Manufacturing Practices (GMP).

Manufacturers and importers remain responsible for ensuring product safety, quality, and regulatory compliance, including post-market surveillance and maintaining accurate, up-to-date records.

The regulation also outlines procedures for modifying authorizations and emphasizes legal consequences for inaccurate submissions. Importantly, obtaining establishment authorization does not replace other regulatory requirements or grant automatic product market approval.

This initiative improves regulatory efficiency while maintaining strict compliance standards for medical device operations in Argentina.

Region: Argentina
Source: https://www.argentina.gob.ar/sites/default/files/rv_instructivos_ddjj_empresas_disp_8799-25-v04.pdf