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Argentina Amends Import Requirements for In Vitro Medical Devices, Creates New Export Regime for Low-Value Goods

Argentina has amended in various ways the import requirements for in vitro medical and diagnostic devices laid out in Disposition 7425/2013. The modifications relate to the verification of compliance with good manufacturing practices as well as the expiration and renewal of GMP certificates. Among other requirements, importers and domestic manufacturers of subject merchandise must initiate a GMP compliance review within 120 days from the date of expiration of the GMP compliance certificate issued by Argentinean authorities. Once the review begins, the existing GMP compliance certificate will remain valid until the issuance of a final decision on whether to grant a new certificate.

Separately, Argentina has created a new simplified regime for the exportation of low-value commercial goods by post. Entities wishing to take advantage of this new regime will be able to export up to US$0.6 million worth of merchandise per year, as long as the FOB value of each export operation does not exceed US$15,000 and the gross weight of each shipment does not exceed 300 kilogrammes. Additionally, the goods to be exported must be made in Argentina and not be subject to any prohibitions, suspensions or quantitative restrictions.

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