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MDSAP And USMCA: 3 Ways Mexico Can Come Up-To-Speed With The Single-Audit Program Targeted By New Free-Trade Accord

 
• By Shawn M. Schmitt

The US-Mexico-Canada (USMCA) treaty calls for the three countries to “recognize audits” performed under the Medical Device Single Audit Program. MDSAP is already used by device makers in the US and Canada so they can undergo one audit by an accredited third party to satisfy quality regulations. That leaves Mexico as the odd country out when it comes to using the popular program – and that means it has some catching up to do after the USMCA is ratified by all three nations. Former longtime FDA official Kim Trautman weighs in on how Mexico can incorporate MDSAP into its regulatory framework.

Concept The border between Mexico and America, a magnifying glass over the world map of Mexico

A short blurb tucked inside an annex of the new US-Mexico-Canada (USMCA) free-trade agreement aims to make it easier for the three countries to align on inspecting medical device manufacturing facilities.

Annex 12.E.4 of the treaty says each country must “recognize audits” performed under the Medical Device Single Audit Program.

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