Mexico and the United States: medical device regulation

Mexico and the United States announced that they continue to make progress in the convergence of their medical device regulations.

Both countries are advancing the Medical Device Regulatory Convergence Project (MDRC), a joint effort under the Standards Alliance in collaboration with Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to support further alignment of Mexico’s medical device regulatory system with international standards to streamline processes and reliability in FDA decisions.

Between 2021 and 2023, the MDRC project trained more than 1,400 participants from the Americas Region on good regulatory practices (BPR), use of international standards, conformity assessment of medical devices and software as a medical device, the Medical Device Single Audit Program (MDSAP) and medical device quality management system standards.

In addition, according to the Mexican Ministry of Economy, Cofepris has formally submitted an application to become an affiliate member of the MDSAP.

At the same time, the agency is focusing on improving its regulations to facilitate the acceptance of MDSAP audits by accredited auditing organisations.

Medical devices

This two-pronged approach aims to optimise resource allocation and ease the regulatory burden for medical device manufacturers.

In the US, medical devices are strictly regulated by the FDA.

According to the Federal Food, Drug and Cosmetic Act (FDCA), a medical device is defined as «an instrument, apparatus, appliance, utensil, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, that, among other things, is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its intended primary purpose through chemical action in or on the body of man or other animals and which is not dependent on being metabolised for the achievement of any of its intended primary purposes. »

This definition makes a clear distinction between a medical device and other FDA-regulated products, such as drugs.