New List of Low-Risk and Deregulated Medical Devices in Mexico

On July 7, 2025, an updated Agreement including an updated list of low-risk and deregulated devices in Mexico was published in the Diario Oficial de la Federación (DOF), directly impacting manufacturers, importers and distributors of low-risk medical devices. The previous Agreement on 22/12/2014 only included a list of deregulated devices, while the Agreement on 31/12/2011 only included a list of low-risk devices.  At this time, the Agreements are only available in Spanish.

Three Distinct Annexes

The new Agreement organizes and clarifies the applicable regulatory requirements across three distinct annexes.

It is important to note that all sterile medical devices are not considered low-risk devices, and are therefore not affected by the updated Agreement.

Numerus devices were added to the list of low-risk devices requiring sanitary registration (Annex I), including non-sterile surgical caps, surgical lights, neurological reflex hammers, and reusable and disposable ear speculas, while other devices previously requiring sanitary registration (Annex I) were moved to Annex II, including a wide range of scales (infant, floor, wheelchair, etc.), plastic mouth openers, blood pressure cuffs, and certain hospital beds.

Transistional Timeline

The transition period is up to 3 years (2025–2028) for manufacturers and importers/distributors to ensure their products are compliant with the updated/new agreement, with the final deadline for compliance beginning in 2029.

What This Means for Manufacturers

• Streamlined Compliance: Products in Annexes II or III benefit from reduced regulatory burden, facilitating easier market access.
• Updated Product Listings: Manufacturers should review the updated lists to determine if their products’ regulatory status has changed, and if so, define the applicable transition period.
• Documentation Review: It is essential to align technical documentation and labeling with the new classifications to ensure continued compliance.

How can MedEnvoy Support

If you have any questions about this summary on low-risk and deregulated devices in Mexico or the accompanying guidance document, or if you require assistance with regulatory reviews, product classification, or compliance planning, our regulatory experts are available to support you – please feel free to reach out here.

Learn more about our Mexico Registration Holder services.