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.
Download our informative COFEPRIS approval process chart.
COFEPRIS registration services
There are a variety of registration pathways in Mexico. Emergo 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.