*COFEPRIS is the department within the Secretaria de Salud (Ministry of Health) that oversees medical device registration and vigilance.
**The US FDA does not issue GMP quality system certificates. Therefore companies most often request an official Certificate to Foreign Government (CFG) from the FDA to demonstrate their compliance with FDA regulations. European Competent Authorities issue a similar document called a Certificate of Free Sale (CFS).
MDRC assists medical device companies worldwide with classification, registration, representation and distributor qualification in Mexico as shown below.
COFEPRIS maintains a large list of medical devices, and each product on this list has a corresponding code that determines its classification (Class I, II or III). Selecting the proper classification code is critical to ensuring a smooth registration process. Our team has a lot of of experience with medical device classification.
A completed COFEPRIS registration dossier contains similar information found in US FDA and Health Canada submission documents. In fact, COFEPRIS now recognizes US FDA classes I, II and III, PMA or Health Canada Medical Device License approvals as meeting most of Mexico’s registration requirements. These devices are also eligible for expedited review by COFEPRIS. If your device already has US or Canadian approval, we will help coordinate the submission to COFEPRIS on your behalf. If your product only has European CE Marking or other national approval, we will leverage information from your existing Technical File or registration dossier to prepare your submission to COFEPRIS.
Our LATAM team will advise you on device labeling requirements and aid in document translation into Spanish, as required by Mexican law.
Foreign companies are required to have a local representative to act as liaison with COFEPRIS. In Mexico, the “Registration Holder” controls the registration of the device. We know companies that can act as Registration Holders for you. Or we can find a Registration Holder that will satisfy your needs and specifications.
Mexico has several major markets for medical devices including Mexico City, Monterrey and Guadalajara. Distributors tend to focus on 1–2 of those areas but rarely have coverage throughout the country. We can help find and qualify the best distributors in specific regions of Mexico to maximize your sales nationwide. Also, we will make sure that your distributors meet all COFEPRIS requirements applicable to medical device distributors
| Validity | 5 years |
| Language | Documents and Labeling must be in Spanish |
| Postmarket Surveillance | MRH must report adverse events and device recalls. |
| Expected Time | Class I Low Risk: 1-3 months. Equivalency from recognized country review: 6-8 months. Standard review: 6-16 months. |
*COFEPRIS is the department within the Secretaria de Salud (Ministry of Health) that oversees medical device registration and vigilance.
**The US FDA does not issue GMP quality system certificates. Therefore companies most often request an official Certificate to Foreign Government (CFG) from the FDA to demonstrate their compliance with FDA regulations. European Competent Authorities issue a similar document called a Certificate of Free Sale (CFS).
MDRC assists medical device companies worldwide with classification, registration, representation and distributor qualification in Mexico as shown below.
COFEPRIS maintains a large list of medical devices, and each product on this list has a corresponding code that determines its classification (Class I, II or III). Selecting the proper classification code is critical to ensuring a smooth registration process. Our team has a lot of of experience with medical device classification.
A completed COFEPRIS registration dossier contains similar information found in US FDA and Health Canada submission documents. In fact, COFEPRIS now recognizes US FDA classes I, II and III, PMA or Health Canada Medical Device License approvals as meeting most of Mexico’s registration requirements. These devices are also eligible for expedited review by COFEPRIS. If your device already has US or Canadian approval, we will help coordinate the submission to COFEPRIS on your behalf. If your product only has European CE Marking or other national approval, we will leverage information from your existing Technical File or registration dossier to prepare your submission to COFEPRIS.
Our LATAM team will advise you on device labeling requirements and aid in document translation into Spanish, as required by Mexican law.
Foreign companies are required to have a local representative to act as liaison with COFEPRIS. In Mexico, the “Registration Holder” controls the registration of the device. We know companies that can act as Registration Holders for you. Or we can find a Registration Holder that will satisfy your needs and specifications.
Mexico has several major markets for medical devices including Mexico City, Monterrey and Guadalajara. Distributors tend to focus on 1–2 of those areas but rarely have coverage throughout the country. We can help find and qualify the best distributors in specific regions of Mexico to maximize your sales nationwide. Also, we will make sure that your distributors meet all COFEPRIS requirements applicable to medical device distributors
