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
ANMAT Bans Alma Lasers Soprano ICE Medical Device (Aug 20, 2026)
2026-08-20 | Argentina ANMAT | Safety Communication | !!! HIGH
On 20 August 2026, Argentina's ANMAT issued an alert prohibiting the medical device 'Alma Lasers Soprano ICE' (manufacturer: Alma Lasers). The affected product is the Soprano ICE equipment; specific lots are not provided in the alert, but the ban indicates serious safety or regulatory concerns. Healthcare facilities, distributors, and users should immediately stop use, sale, and distribution, and verify registration status with ANMAT.
Tags: anmat, medical_device_ban, alma_lasers_soprano_ice
ANMAT Prohibits One Unit of FotoFinder Dermatoscope (Aug 10, 2026)
2026-08-10 | Argentina ANMAT | Safety Communication | !!! HIGH
On August 10, 2026, Argentina's ANMAT issued an alert prohibiting one unit of the FotoFinder brand dermatoscope. The prohibition is unit-specific and based on safety concerns identified in the official ANMAT notice. Affected users and distributors should identify the prohibited unit, remove it from use, and follow ANMAT instructions.
Tags: argentina_anmat, dermatoscope, product_ban, medical_device_safety