Article: Medical Device Regulatory & Marketing Requirements Worldwide-2001[TM].

International Trade Administration US Dept of Commerce Washington DC

Biomedical Market Newsletter[TM] Costa Mesa CA USA

ARGENTINA

Updated 12/08/00

The National Administration of Drugs, Foodstuffs and Medical Technology (ANMAT) under the Ministry of Health, is the regulatory authority. Products covered under the Resolution 255/94, Decree No. 2.505/ 95 must be registered with ANMAT.

The importer is responsible for registration of products by submitting a product report of technical information including documents that are legalized by the Argentine Consulate or Embassy in the product's country of origin.

An Argentine ...

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