Mexico medical device registration requires all manufacturers to obtain regulatory approval from COFEPRIS, Mexico's medical device regulator, before distributing devices in Mexico. Foreign manufacturers must appoint an in-country Mexico Registration Holder (MRH) to submit your registration dossier and application fees. Low-risk devices follow a simplified route with faster reviews; higher‑risk devices require full review and, potentially, local testing.
Mexico’s medical devices market is set to grow at a 7.6% CAGR (2024–2029), despite short-term economic challenges. Growth is driven by higher healthcare spending, an aging population, and rising chronic diseases. The in-vitro diagnostics market is expected to reach $3.5B by 2033.
Confirm the product classification according to the product manual. Classify the grouping and number of registrations, then confirm the registration path (Standard or Equivalency route) to obtain COFEPRIS medical device registration. Effective September 1, 2025, existing authorizations from IMDRF or MDSAP member markets can be leveraged for the Equivalency (Abbreviated) route.
Foreign manufacturers must appoint a local in-country representative in Mexico called the Mexico Registration Holder (MRH). Confirm the information of the distributor(s) in the application materials.
Compile a technical dossier in accordance with COFEPRIS guidelines and specific to the device, classification, and route. Prepare and organize the following documents:
After verifying the full set of submitted materials, the MRH submits the documents to COFEPRIS and pays the official fee.
Upon successful completion of review, COFEPRIS will issue a registration certificate and an operating license, authorizing manufacturers to legally import and market their device in Mexico.
Maintain your Mexico medical device registration by implementing and maintaining a robust post-market surveillance system, including adverse event reporting. Ensure registrations are renewed every five years to maintain market presence.
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.
The cost of registering a medical device with COFEPRIS depends on the device classification, dossier complexity, and whether multiple registrations are filed together:
Ongoing expenses include an annual fee to the local representative, fees for processing modifications, and costs for post-market surveillance (PMS) and vigilance activities. A budget of about $5,000 per year should cover these obligations, but costs can increase if extensive vigilance is required or a large number of modifications are filed.
Timelines for COFEPRIS registration vary by pathway, device class, and dossier completeness. Compiling and submitting an application typically takes 3–4 weeks once all requirements are met.
The new Abbreviated Pathway (Equivalence Route), which leverages prior approvals from many international regulators, introduced a target COFEPRIS review time of 30 working days. While the target review time represents a major improvement from prior COFEPRIS review times, some submissions may still take longer than 30 days for approval.
While ISO 13485 is not legally mandatory, COFEPRIS expects manufacturers to provide evidence of a robust quality management system. Acceptable documentation includes an ISO 13485 certificate, CE Mark, MDSAP, or a Certificate of Good Manufacturing Practices. These support your application, especially for the Equivalence route, and help demonstrate compliance with safety and performance standards.
Yes, there is a specific list of medical devices classified as low risk, which determines whether health registration is mandatory or not. Devices on this list may not require registration, simplifying the process for certain low-risk products in the Mexico medical device market.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us
