Mexico Acuerdo Dispositivos Médicos 2025 Update

Mexico’s Acuerdo Dispositivos Médicos Julio 2025, published in the Diario Oficial de la Federación (DOF), the “Acuerdo Dispositivos Médicos Julio 2025”, updates how low-risk medical devices are classified and regulated. COFEPRIS introduces new registration timelines, GMP requirements, and a revised list of exempt products. These updates replace previous 2011 and 2014 frameworks and are critical for companies managing medical device registration in Mexico.

Key Changes in the 2025 Acuerdo

Annex One – Registration Required
Low-risk medical devices now listed in Annex One must obtain sanitary registration. COFEPRIS must respond within 20 business days. Devices previously exempt must register between 2025–2028, based on their listing number, with a grace period until 2029.

Annex Two – Exempt but Compliant
Devices in Annex Two don’t need sanitary registration or import permits but must:

• Meet Good Manufacturing Practices (GMP)

• Comply with technovigilance

• Present a declaration of conformity at customs

• Have a regulatory representative in Mexico

Annex Three – Not Considered Medical Devices
Products listed here are fully exempt from regulation, as they’re not classified as medical devices.

Impact on Manufacturers and Importers

• Reassess your product’s status under the new annexes.

• Prepare for phased registration if applicable.

• Ensure GMP and post-market surveillance protocols are in place.

• Secure a local regulatory representative if needed.

Next Steps for Compliance

• Review the full DOF publication:
  Official DOF Acuerdo Dispositivos Médicos Julio 2025

• For specific guidance on classification, registration, and compliance in Mexico, visit: Pure Global – Mexico Medical Device Market Overview  

Final Note

‍The new Acuerdo aligns Mexico’s regulatory system with modern best practices. Companies must act now to ensure seamless market continuity and avoid delays beyond 2029.

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