iiMED announces full compliance with the new USMCA documentation requirements

The adoption of the US-Mexico-Canada Agreement (USMCA) offers key upgrades for US-based medical device manufacturers operating in Mexico for its nearshoring benefits. Notable changes include recognition of international standards, elimination of duplicative regulatory requirements and expansion of intellectual property protections.

With outsource manufacturing services in Mexico, iiMED Medical Manufacturing Solutions has conducted in-depth research to assess the Agreement’s impact on our customer’s medical devices. iiMED is pleased to announce we are fully compliant with the new USMCA documentation requirements.

iiMED manufactures Class 1 & II medical devices with tariff classifications typically in plastics, textiles or medical accessory categories.

  • Our partners are pleased to learn that Rules of Origin and Country of Origin markings remain the same as under NAFTA. As was the case with NAFTA, a good does not need to qualify for a tariff exemption to be marked as “Made in Mexico.”
  • One documentation change to note is on the USMCA Certificate of Origin. With USMCA, an importer, exporter or producer may complete the document including the new “Certifier” required section.
  • iiMED will continue to be the “Certifier” of all originating goods and will maintain records for Customs and Border Patrol.

With benefits like rapid start up, flexibility, easy communication and cost-effective labor, nearshore manufacturing of medical devices is more lucrative than ever before. With simplified trade, USMCA helps to spur more manufacturing in North America.