What Registration Is Required to Export Medical Devices to Mexico?

To export medical devices to Mexico, the manufacturer must obtain a sanitary registration (registro sanitario) from COFEPRIS, submitted through a registration holder established in Mexico. The application requires risk-classified technical documentation, evidence of a quality management system, proof of approval or free sale in the country of origin, and labelling and instructions for use in Spanish. Only after the registro sanitario is granted may the device be imported and sold in Mexico. Registration is typically valid for five years and must be renewed before expiry.

Regulatory Authority

Medical devices in Mexico are regulated by the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). Placing a device on the Mexican market requires a sanitary registration issued by COFEPRIS.

Official website: https://www.gob.mx/cofepris

Key Registration Requirements

• Regulatory authority: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
• Local representation: a registration holder established in Mexico (responsable sanitario) is required to file and hold the registration.
• Core documentation:
  • Technical file, prepared according to the applicable risk classification;
  • Evidence of a quality management system, typically ISO 13485 certification;
  • Proof of approval or marketing authorisation in the country of origin;
  • Labelling, packaging and instructions for use in Spanish;
  • Authorisation from the manufacturer to the local registration holder.
• Validity: generally five years, subject to renewal.
• Language of submission and labelling: Spanish.

Practical Considerations for Manufacturers

The registration holder in Mexico is legally responsible for the registration and for post-market obligations, so the scope of the mandate, change-notification procedures and pharmacovigilance or vigilance responsibilities should be defined contractually before submission. Documentation prepared for other markets can often be leveraged, but Spanish labelling, the country-of-origin approval evidence and the risk classification applicable under Mexican rules should be confirmed at the planning stage, as they commonly determine the timeline.

Frequently Asked Questions

Can a foreign manufacturer register without a local company in Mexico?

In practice, no. Applications are normally filed through a registration holder established in Mexico (responsable sanitario), who holds the sanitary registration on behalf of the manufacturer. Foreign manufacturers should therefore appoint and authorise a qualified local holder before initiating the COFEPRIS procedure.

How long is the Mexican sanitary registration valid?

Registration is generally valid for five years. Renewal must be initiated before expiry to avoid interruption of import and sale; the renewal timeline should be built into the regulatory maintenance plan.

Is Spanish labelling mandatory?

Yes. Labelling and instructions for use in Spanish are part of the core documentation submitted with the application and are required for the device to be imported and sold in Mexico.

Source and Verification

Source: COFEPRIS official website and published regulatory pages — https://www.gob.mx/cofepris. Verification date: 2026-11-02.

This article is a summary of regulatory information and does not constitute legal advice. The latest requirements of the competent authority prevail. AIMEILI (Ameli) is a platform supporting medical device companies with overseas registration; it is not a CRO and not an authorised representative.