Mexico Medical Device and IVD Registration and Approval
Mexico is the second-largest medical device market in Latin America behind Brazil, and can prove a profitable target for medical device manufacturers. However, Mexican registration requirements are confusing and 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
- 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 Ia "low risk," Class I, Class II and Class III. The registration process can be challenging in Mexico because there is no single published document, law or guidance that allows manufacturers to ascertain the classification of their device before beginning the registration process with COFEPRIS. However, our consulting team in Mexico can review the variety of documentation and publications that must be referenced in order to determine if the product is a medical device/IVD and its proper classification before beginning the registration process. Ultimately, COFEPRIS decides the classification of a particular medical device or IVD upon submission of the registration documents but we typically do not encounter differences between the classification determined by our experts and the COFEPRIS decision.
COFEPRIS registration services
There are a variety of registration pathways in Mexico which could be based on your regulatory status in the US, Canada and Japan. 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.