Streamlining Your Medical Device Registration with COFEPRIS

As the second-largest country in Latin America, with a population exceeding 125 million and major urban centers in Mexico City, Monterrey, and Guadalajara, Mexico represents a significant market for medical devices, with approximately 80% of devices imported. This import reliance highlights the substantial opportunities for foreign medical device manufacturers.

Device Classification and Regulatory Pathways

Navigating COFEPRIS Regulations

Regulatory Authority

The Federal Commission for the Protection of Sanitary Risks (COFEPRIS) is an autonomous body of the Ministry of Health in Mexico that grants health registrations and authorizations for medical devices to be marketed. The registration process for medical devices in Mexico can be complex, but it can be accelerated through an equivalence agreement that simplifies the documentation review process for products already approved in the USA, Canada, or Japan.

Classification

A product is considered a medical device in Mexico if it falls into one of six categories based on its function and purpose, which are: medical equipment, prosthetics, orthotics and functional aids, IVDs, dental supplies, surgical and dressing materials, hygiene and SAMD. After identifying the category, medical devices are classified based on their permanence or degree of exposure to the human body and will be classified for registration purposes according to the risk involved in their use in class I, II or III. There are medical devices that by nature are classified as low risk. For these products, there is a specific list that will determine whether health registration is mandatory or not.

Key Requirements

To market in Mexico, foreign manufacturers must:

  • Appoint a local Holder responsible for the registration process with COFEPRIS.
  • Prepare and submit a comprehensive technical dossier, considering the Equivalency Agreement route for expedited review if applicable.
  • Ensure registrations are renewed every five years to maintain market presence.
  • Certificate of Good Manufacturing Practices or ISO 13485
  • Certificate of Free Sale
  • Letter of Representation
How We Can Help

Tailored Support for Market Entry

Our expertise in Mexican regulations provides seamless market entry:

  • Guidance on product classification and the most efficient regulatory pathway.

  • Compilation of the technical dossier required for COFEPRIS registration.

  • Acting as your Holder, managing the submission process and ensuring compliance with post-market obligations.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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