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 Equivalence route) to obtain COFEPRIS medical device registration.
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.
Prepare and organize the following documents:
Compile a technical dossier in accordance with COFEPRIS guidelines and specific to the device, classification, and route.
After verifying the full set of submitted materials, the MRH submits the documents to COFEPRIS and pays the official fee to assist in processing the authorities’ request for subsidy.
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.
Manufacturers should expect to pay between $4,000 and $8,000 USD per device for in-country representation and registration, plus $1,000 to $2,000 USD in government fees. Costs vary depending on device classification and required documentation.
Registration takes approximately 6–12 months via the Equivalence route or 10–18 months via the Standard route. If COFEPRIS issues a deficiency letter, expect an additional 6–8 months, making the total timeline as long as 26 months in the worst-case scenario.
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.
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