COFEPRIS Mexico Medical Device Registration

Medical device and In Vitro Diagnostic (IVD) device registrations in Mexico are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). Registration requirements are established under the General Health Law (Ley General de Salud) and the Regulations of Health Supplies (Reglamento de Insumos para la Salud), alongside applicable NOM standards such as NOM-241-SSA1-2025 for Good Manufacturing Practices.

Foreign manufacturers must appoint a local Mexico Registration Holder (MRH). The MRH is a legally established entity in Mexico who acts as the official representative for the foreign manufacturer. The MRH is responsible for obtaining and holding the sanitary registrations for your medical devices, as well as coordinating with COFEPRIS. It is possible to transfer your registrations to a different holder through formal regulatory channels. However, this process can be cumbersome, so it’s important to thoroughly vet your chosen MRH. Once appointed, the MRH will identify which regulatory pathways, depending on the product and available reference approvals, the foreign Manufacturer shall follow.

COFEPRIS Mexico medical device regulatory pathways

Mexico offers two registration routes: the Standard Route and the Equivalency (Abbreviated) Route:

Standard Route (Full Technical Review)

• Process: COFEPRIS conducts a comprehensive review of the submitted technical dossier, including clinical, safety, and labeling documentation.

• Requirements: A complete technical file with clinical and safety data, quality system evidence, labeling in Spanish, a Free Sale Certificate or Foreign Government Certificate, and a Letter of Representation.

• Timeline: Review timelines vary due to the complexity and volume of submissions.

• Renewal: Initial registrations are valid for 5 years; subsequent renewals may be granted for up to 10 years.

Equivalency Route (Abbreviated Pathway)

• Process: COFEPRIS grants expedited authorization based on prior approval from a recognized reference authority.

• Eligibility: Effective September 1, 2025, approvals from IMDRF and MDSAP member markets may be leveraged, including FDA, EU CE marking (MDD, IVDD, MDR, IVDR), Health Canada, Swissmedic, ANVISA, TGA, MFDS, NMPA, and other ICH-, WHO-, IMDRF-, or MDSAP-recognized bodies.

• Requirements: The device must be identical to the version approved by the reference authority. Required documentation includes a Certificate of Free Sale and conformity assessment, foreign approval, Clinical Evaluation Report, risk analysis, draft labeling in Spanish, and quality system evidence.

• Timeline: COFEPRIS should issue a decision within 30 business days of receiving a complete application. Delays may occur when there is a high volume of submissions.

• Renewal: Initial registrations are valid for 5 years; subsequent renewals may be granted for up to 10 years.

Other COFEPRIS registration requirements

• Mexico Registration Holder (MRH): Mandatory for all foreign manufacturers. The MRH submits applications, pays fees, and acts as the local regulatory contact with COFEPRIS.

• Distributor information: Distributor details must be confirmed and included in the application materials.

• Translation: All submissions and labeling must be in Spanish.

• Quality system evidence: While ISO 13485 is not legally required, COFEPRIS expects evidence of a robust quality management system, such as ISO 13485 certification, CE Mark, MDSAP, or a Certificate of Good Manufacturing Practices.

• Post-market obligations: Manufacturers must maintain post-market surveillance systems, including adverse event reporting, throughout the registration lifecycle.

What documentation is required to register a medical device or IVD with COFEPRIS?

Documentation requirements depend on the device classification and registration route, but a complete dossier generally includes:

• Free Sale Certificate or Foreign Government Certificate (from reference market if using Equivalency route)

• Certificate of Good Manufacturing Practices, ISO 13485, CE Mark, MDSAP, etc.

• Foreign approval (required for Equivalency route)‍

• Technical file, including clinical and safety data (required for Standard route) ‍

• Device labeling in Spanish

• Letter of Representation

• Technovigilance Report

What is a Mexico Registration Holder and why do you need one?

Before submitting a medical device or IVD registration to COFEPRIS, foreign manufacturers must appoint a Mexico Registration Holder (MRH) to serve as their local regulatory representative. The MRH is responsible for submitting registration dossiers, paying government fees, and maintaining communication with COFEPRIS throughout the product’s approval and post-market lifecycle.

Sanitary registrations in Mexico are issued in the name of the MRH. This means the MRH is legally recognized as the registration holder. Because transferring a registration to a new MRH typically requires a formal process with COFEPRIS, manufacturers should evaluate potential representatives carefully before proceeding.

Do foreign medical device manufacturers also need an importer and a distributor in Mexico?

Yes. Foreign manufacturers typically need an MRH, an authorized importer, and distributor to distribute medical devices and IVDs in Mexico. The MRH acts as the legal regulatory representative and holds the sanitary registration issued by COFEPRIS, while the importer and distributor are responsible for physically bringing the product into Mexico and ensuring compliance with customs and labeling requirements. These roles can be fulfilled by the same organization or by separate entities, but all must be documented and authorized as part of the regulatory process.