Argentina
Argentina is one of the most regulated medical device markets in South America, with strong oversight from local authorities. The sector is valued at over $2.5 billion, with an average annual growth rate of 7%.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).
Device Classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
- Class IV: Very high risk
Specific Local Requirements
| Language | Documentation in Spanish. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | ISO 13485. CE, FDA, and Certificate of Free Sale facilitate the process. |
| License Validity | Three-year renewal with additional audits for Class III and IV devices. |
| Carbon footprint declaration | Mandatory for single-use devices. |
Challenges and Operational Advice
- Bureaucratic process: The registration process may face delays due to documentation requests.
- Strict regulations: ANMAT enforces rigorous controls to ensure device safety.
- Pre-submission meeting: Mandatory for innovative devices to reduce rejection risks.
Why Choose ISEMED
- Latin America Expertise
Specialized support for registration with ANMAT. - Comprehensive Assistance
From dossier preparation to liaison with authorities.
FAQ
- Is a local representative required? Yes, Titular de Registro.
- Documentation language? Spanish.
- License duration? 3 years for Class III and IV devices.