Mexico COFEPRIS Regulatory Approval Process for Medical Devices and IVDs

The Mexico medical device approval process explained

Step 1
Determine if your device or IVD is on the COFEPRIS list of deregulated products. If not, determine classification of your device based on rules found in Criteria for Medical Device Classification published on the C OFEPRIS website.

Step 2
For all classes: If you have no local presence in Mexico, appoint a Mexico Registration Holder (MRH) as your in-country regulatory representative. Your MRH manages your device application and controls your medical device/IVD registration in Mexico.

Step 3
For all classes: Demonstrate home country approval.* A common way to satisfy this requirement is with a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).

Step 4
For all classes: Designate a qualified distributor to bring your medical device or IVD into Mexico. Your distributor(s) should be specified in your registration dossier prior to submission to avoid having to modify your registration(s) later.

Step 5
For Class I Low Risk: Submit application, including basic company and device information, to COFEPRIS. All documents must be submitted in Spanish.

For Classes I, II, and III: Prepare a detailed Registration Dossier including draft labeling and Instructions for Use. Provide proof of compliance with quality management requirements (e.g. ISO 13485 certificate) and/or a CE certificate. --OR--

If your device is already registered in the US, Canada or Japan, your device may qualify for an equivalency review process with fewer documentation requirements.*

Step 6
For Classes I, II, and III: Depending on your product's features and intended use, specific test reports could be required. In general, reports from tests performed outside Mexico according to international standards are accepted.

Step 7
For all classes: All devices must follow labeling requirements found in NOM-137-SSA1-2008. Labeling and instructions for use must be in Spanish.

Step 8
For Classes I, II, and III: MRH submits Registration Dossier to COFEPRIS or Third Party Reviewer** for review, along with payment for registration fees. All documents must be submitt ed in Spanish.

Step 9
For all classes: Certificate issued by COFEPRIS and proof of registration published on COFEPRIS' website. Registrations are valid for 5 years. Some products will require an import permit bef ore they may be brought into Mexico.

Step 10
You may now begin marketing your device in Mexico. Update your reporting procedures to comply with Mexico Technovigilance requirements found in NOM-240-SSA1-2012.

* The "equivalency route" utilizes more summarized documentation. However, despite the name, your time to approval using this process may actually take longer than the standard review process. The equivalency route is also slower if you need to submit a modification in the future. Submissions leveraging an equivalency route are NOT eligible for Third Party Review. Companies leveraging US equivalency must be able to provide an Establishment Inspection Report (EIR) or ISO 13485 certificate for each manufacturing site. Companies without home country approval can register under a qualifying equivalency agreement.

** COFEPRIS has authorized certain third party companies to conduct reviews for Class I, II and III devices and "pre-approve" the application. Third Party Review may reduce the review time by up to half, but they charge an additional fee. Companies using the "equivalency" route cannot submit through a third party reviewer.

This is a simplified overview of the process. COFEPRIS may choose to audit your submission and request more documents, which will add time to your approval.

Chart updated 07/2016.