To enter the Mexican market, all in vitro diagnostic Medical Devices must be registered with the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the body responsible for marketing authorisation, verification of compliance with national regulations and post-marketing surveillance.

For foreign manufacturers, the application for registration must be submitted through an Authorised Local Representative (Mexican Registration Holder—MRH). Registration must primarily comply with the General Health Law (Ley General de Salud), the Regulation of Health Supplies (Reglamento de Insumos para la Salud), and any specific applicable regulations.

To obtain approval from COFEPRIS in Mexico, two routes are available:

• Equivalence review: This procedure is reserved for devices already approved in the United States, Canada, or Japan. It requires a summary file with less detailed technical information and offers faster turnaround times than the standard review.
• Standard review: involves the submission of a detailed technical dossier, with longer deadlines.

The technical dossier must include the ISO 13485:2016 certificate or the Mexican Good Manufacturing Practices (GMP) certification.

The classification of devices is based on the level of risk:

• Class I: minimal risk.
• Class II: moderate risk, subject to safety and performance testing.
• Class III: high risk and requires clinical studies.

For Class II and III devices, clinical studies conducted in Mexico may be mandatory, even if the product is already authorised in other countries.

As of 2022, the registration request can also be made digitally via the DIGIPRIS platform.

The registration process includes mandatory inspections of production sites, especially for Class II and III devices. These inspections are conducted by bodies accredited by COFEPRIS and aim to ensure the manufacturer’s compliance with Mexican regulatory requirements.

During the evaluation, COFEPRIS may request additions or further tests.

Applicant

Foreign manufacturers are obliged to appoint an Authorised Local Representative (Mexican Registration Holder – MRH) to ensure compliance throughout the product life cycle, from initial registration to post-marketing.

Timeframes and Costs

The duration of the registration process in Mexico depends on the risk class of the device. Generally, the timeframe varies between 4 and 12 months, but it can be extended if COFEPRIS requests further additions or additional documentation.

The costs associated with registration differ according to risk class. They range from around USD 13,000 for Class I devices to USD 25,000 for Class III devices.

Certificate Validity

Registration with COFEPRIS is valid for five years.

Documentation Language and Labelling

All technical documentation and product labelling must be in Spanish.

Useful information

Mexico is the second largest medical device market in Latin America, after Brazil, and values innovative and high-quality medical technologies. Mexico adopts a regulatory approach harmonised with international standards, such as those of IMDRF.

Recent regulatory initiatives have focused on improving the traceability of Medical Devices, digitising registration processes and reducing overall approval times.

Mexico also participates in several trade agreements, such as the Pacific Cooperation Agreement, which facilitate the import and export of Medical Devices.