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Mexico is the second-largest medical device market in Latin America behind Brazil, and can prove a profitable target for medical device manufacturers. However, little information on the process is available in English from COFEPRIS, a division within the Mexican Ministry of Health (Secretaria de Salud) responsible for medical device and IVD oversight. We can help obtain approval for your medical device or IVD in Mexico. We can:
- Determine classification of your medical device in Mexico
- Help you determine a grouping strategy for your registration
- Prepare and submit registration application documents to COFEPRIS
- Work to answer questions from COFEPRIS during the submission process
- Act as your independent "Mexico Registration Holder"
The Mexican medical device approval process
Medical devices in Mexico are divided into four classes of increasing risk: Class I "low risk," Class I, Class II and Class III. The rules are an adaptation of the European classification rules, with some differences that are unique to Mexico. Additional grouping requirements for Mexico apply to the determination of how many registrations are required, and we have the experience to help you define a grouping strategy. Ultimately, COFEPRIS decides the classification and grouping of a particular medical device or IVD upon submission of the registration documents.
The registration process can be challenging in Mexico, not only because the classification and grouping differs from other countries and regulatory systems, but also because of the lack of transparency at COFEPRIS leading to such difficulties as approval timelines that greatly differ from published timelines, and country-specific document requirements. Emergo has the experience and expertise to help you prepare an application which aligns with COFEPRIS’ expectations, and to understand approval requirements and timelines.
Read our informative article about the medical device registration process in Mexico or download our free COFEPRIS approval process chart.
COFEPRIS registration services
There are a variety of registration pathways in Mexico. Emergo Group will help you determine which pathway you are eligible to register under and inform you of the documentation that is required within that applicable registration route. It is worth noting that all documentation must be submitted in Spanish.
Preparation of the Mexico medical device registration documents takes up to 2 months and a decision from COFEPRIS is typically rendered 4-12 months thereafter, depending on which registration route was selected. Companies may also opt to submit their registrations to a Third Party Reviewer, a company authorized by COFEPRIS to “pre-approve” applications. While this incurs an additional cost, it can reduce the review time by 50% or more compared to an application submitted directly to COFEPRIS.
COFEPRIS charges registration fees per application (fee depends on classification) and registration is valid for 5 years. In some cases the product must be tested in Mexico before the registration. We can assist in coordinating this testing before the registration if it is required.
Please contact us for more information on medical device registration and approval in Mexico.
Commonly 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), for example, would be accepted.
What are the third party reviewers (TPR)?
In 2012 COFEPRIS introduced the option of third party reviewers. Through this option, companies can pay a TPR, which are independent, accredited commercial entities, to “pre-approve” medical device applications. They will review the dossier in detail, often requesting more information from the manufacturer bfore issuing their preapproval letter; COFEPRIS will complete a final review and issue the registration certificate. Third party reviewers are local Mexican companies and are not associated with any globally recognized registrars/notified bodies.
Can Emergo Group recommend a third party reviewer to me?
If selected as your registration holder, Emergo Group 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, as well as meet other route-specific requirements, such as having been inspected by the FDA and have their 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. Under this route a fair amount of technical information is still required; 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 and now takes up to one year to obtain approval. The fastest method at the moment is the TPR system mentioned above, which takes an average of four months.