Argentina

1. Authorities

In Argentina, the agency responsible for regulating medical devices is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), which is part of the Ministry of Health.

2. Relevant Regulations

The regulatory framework for medical devices in Argentina is Resolution 3802/2004, and the guiding documents Disposition 4306/99, Disposition 2318/02, Disposition 2319/02, Disposition 3266/13

Medical devices in Argentina are classified into Class I, Class II, Class III & Class IV.

3. Time estimation

According to different medical device classifications, the average registration period for Class I is 1-2 months, and the average registration period for Class II/III/IV is 6-8 months. The registration period for products with high risk levels will be appropriately extended.

4. Local Representatives

For manufacturers headquartered outside of Argentina, they are also required to appoint a Local Authorized Representative in Argentina (AAR), who is primarily responsible for processing medical registration application submissions and communicating with the authorities, as well as post-marketing matters.

5. Successful Cases

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