Argentina ANMAT Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Key Legislation:
- Disposicion ANMAT 2318/2002: MERCOSUR Technical Regulation for Registration of Medical Products
- Disposicion 727/2013: Registration requirements and procedures
- Disposicion 3266/2013: Good Manufacturing Practices
- Disposicion 11467/2024: Essential safety and performance requirements
- Disposicion 64/2025: Updated registration requirements
- Disposicion 8799/2025: Simplified approval for Class I/II devices and IVD A/B
- Disposicion 224/2026: Used and refurbished medical device import rules
Classification: Risk-based, 4 classes (MERCOSUR framework):
- Class I (low risk) | Class II (low-medium risk) | Class III (medium-high risk) | Class IV (high risk)
Registration Pathway:
- Appoint a local Authorized Agent (AAR) -- mandatory for foreign manufacturers
- Classify the device per MERCOSUR rules (Annex II of Disp. 2318/2002)
- Prepare technical dossier (requirements vary by class)
- Submit application via HELENA online system
- ANMAT review (legal term: 180 days; actual: 12-18 months for Class III/IV)
- Certificate of Registration issued (valid 5 years, renewable)
Key Requirements:
- Local AAR mandatory for foreign manufacturers
- GMP certificate / ISO 13485 required
- Certificate of Free Sale (CFS) from a recognized authority
- Risk management report (ISO 14971)
- Class I/II: simplified notification via sworn declaration (Disp. 8799/2025)
- Registration validity: 5 years, renewal within 90 days before expiry
Current Key Guidance:
Latest Updates
No recent updates available. Please check back later.