Argentina Market Access for Medical Device

REGULATORY AGENCY

• National Administration of Drugs, Foodstuffs and Medical Technology (ANMAT)

REGULATIONS

• The domestic manufacture or import of medical products into the Argentine market must be registered with ANMAT, in conformity with MERCOSUR Technical Regulations for Registration of Medical Products.
• All medical devices are required to meet the essential requirements in disposition 4306/99.
• Good Manufacturing Practice (GMP) for medical devices should be applied and certified according to disposition 191/99.
• A DoC with the MERCOSUR legislation is required for Class I devices.
• A Certificate of Free Sale is required for all devices.
• A risk analysis and clinical trials are also required for Class III and IV devices.

GUIDELINES

• An office or a local distributor in Argentina registered with the Ministry of Health is required.
• Manufacturers are required to submit technical information with registration, including documents that are legalised by the Argentine Consulate or Embassy in the product’s country of origin.
• Devices are divided based on the level of risk, into Class I, II, III and IV, with Class IV representing the highest risk.

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