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Mexico Medical Device and IVD Registration and Approval

Submitted COFEPRIS Mexico RegistrationsMexico is the second largest medical device market in Latin America behind Brazil, and can prove to be a profitable target for medical device and IVD manufacturers.

However, registering a device or IVD in Mexico can be challenging. Little information on the registration process is available in English from COFEPRIS, the division of the Mexican Ministry of Health (Secretaría de Salud) responsible for medical device and IVD oversight.

Proper medical device classification is important for success with COFEPRIS

The first step towards registration in Mexico is to determine proper classification of your medical device. Medical devices in Mexico are classified based on increasing risk as Class I Low Risk, Class I, Class II and Class III. Classification rules are an adaptation of European rules, with some differences that are unique to Mexico. 

Family grouping may be advantageous if your device includes accessories or additional components and can impact the number of registrations required. 

The medical device approval process in Mexico

If you have no local presence in Mexico, you will need to appoint a Mexico Registration Holder to serve as your in-country representative.

For lower risk devices, an application with basic company and device information must be submitted to COFEPRIS. 

Equivalency Review Process

If your device has been approved in the US, Canada or Japan, you may qualify for an equivalency review. Equivalency reviews require the submission of a Summary Dossier with less detailed technical information, and initial registration may be faster than the standard review process.

Standard Review Process

If preparing your device to register through the standard review process, you must prepare a detailed Registration Dossier that includes full product technical information and applicable testing results. Applications going through the standard review process are also eligible for Third Party Review, which has the potential to expedite the approval process, and incurs additional cost to pay for the Third Party Reviewer

Get more information on the Mexican registration process by downloading our COFEPRIS approval process chart.

How Emergo can assist with device and IVD registration in Mexico

With offices in Mexico City, Emergo understands the importance of approval requirements and timelines in Mexico. Our experienced consultants can help you prepare an application that aligns with COFEPRIS requirements. We will:

  • Help you determine the proper regulatory pathway for your devices and inform you of the documentation required within the applicable registration route.
  • Determine classification of your medical device or IVD
  • Help you determine a grouping strategy for your registration
  • Act as your independent Mexico Registration Holder
  • Prepare and submit registration application documents to COFEPRIS
  • Coordinate translation of submission materials into Spanish
  • Work to answer questions from COFEPRIS during the submission process

Please contact us for more information on medical device registration and approval in Mexico.

Ask us for detailed information about Mexico device registration services.

Learn about the process, costs and timelines.

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Frequently Asked Questions

Is ISO 13485 required in order to register in Mexico?

Technically no, but companies must provide proof of an audited quality system in order to register in Mexico. Most manufacturers provide their ISO 13485 certificate, however, a quality system certificate issued by a government agency, such as the Korean Ministry of Food and Drug Safety (MFDS), would be accepted.

What are the third party reviewers (TPR)?

In 2012, COFEPRIS introduced the option of third party reviewers (TPR). Through this option, companies can pay a TPR, which are independent, accredited commercial entities, to “pre-approve” medical device applications. Third party reviewers are local Mexican companies and are not associated with any globally recognized registrars/notified bodies. They will review the dossier in detail, often requesting more information from the manufacturer before issuing their pre-approval letter. COFEPRIS will then complete a final review and issue the registration certificate.

Can Emergo recommend a third party reviewer to me?

If selected as your registration holder, Emergo  will actually need to contract with the TPR on your behalf. As a part of this process, we’ll provide feedback on the reviewers that we have worked with as well as their pricing, so that you can make an informed decision. We will also help in communicating with them throughout the process.

What is the “fast track” process?

The “fast track” process, also known as the Equivalency process, is a regulatory route available to companies that have “approval” in Canada, the US, and Japan. Companies must also meet other route-specific requirements, such as having been inspected by the FDA with an inspection report available. This was introduced in late 2010 as another way for COFEPRIS to manage their tremendous backlog in device reviews by minimizing the amount of technical data companies had to provide, as well as provide some comfort that the products had already undergone a rigorous review through a credible regulatory authority.

A fair amount of technical information is still required for this route; however, the application review is simplified. When initially implemented, approvals were issued extremely quickly in comparison to the “standard” process; however, as time goes on, this timeline has also crept upward. The fastest method at the moment is the TPR system mentioned above.

How important is family grouping to the registration process?

It is as important as device classification. The family grouping impacts the number of registrations you must complete, which can certainly impact your costs and timeline. For example, devices which might be grouped in one registration in a market such as Europe commonly require multiple registrations in Mexico. This adds to the time and cost of your registration project.

Family grouping depends on factors such as intended use (implants for shoulders may not be grouped with implants for knees), raw materials (stainless steel may not be grouped with aluminum) and other factors. Emergo has the experience to help you define a grouping strategy to make the most of your time and budget.