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Argentina Standards: Medical Devices

Discussions of certification and testing standards for vertical industrial products, import regulations, temporary Entry, tariffs, prohibited and restricted imports to Argentina.

Argentina Standards: Medical Devices

Postby qszheng_forum » Mon Nov 17, 2008 1:42 pm

ANMAT has adopted the Mercosur standards for medical equipment. Many Argentine importers are requesting that certification be updated and supplied by exporters. Disposition ANMAT#194/99 and Disposition ANMAT#2319/02 are modified by Disposition ANMAT#1627/06 establishing the product registration procedures and information requirements to register medical products. These requirements (established by 1627) are levied on both domestic producers and importers.

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 importer/distributor must submit a registration application with the following information:

1) Legalized Certificate to Foreign Government (or Certificate of Foreign Sale)
2) Final Product Drawing
3) List of Components/Materials
4) Manufacturing Location
5) Manufacturing Method (Flowchart)
6) Labels/Directions for Use
7) Sterilization Parameters
8) Sterility Test Report/Certificate
9) Packaging Materials
10) Package Integrity Tests
11) Quality Control Test Methods/Records
12) Quality Control Certificate
13) Physical Testing Reports
14) Bio-compatiblity Reports
15) ETO Residual Test Reports
16) Clinical Publications
17) Product Brochure/Catalog Page
18) FDA Status/Approval Letter

Product Certification
Product certification in Argentina is mostly voluntary. Some U.S. marks and product certifications are well known and accepted in the country. There is no legal mandate to retest products that have already been approved in their country of origin. However, any certification that may be required is a contractual matter to be decided between the buyer and the seller. Medical devices and pharmaceuticals are the purview of ANMAT, the National Administration of Pharmaceuticals, Foods and Medical Technology (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica). ANMAT is accepting Country of Origin Certificates for Foreign Governments, legalized CE marks, ISO certifications that are legalized, or a legalized Certificates of Free Sale.

For information on Argentine and MERCOSUR standards for medical products contact:
Avenida de Mayo 869, 3er piso
1084 Buenos Aires, Argentina
Tel and fax: 54-1-14-345-7145
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