Mexico

Regulatory process for Medical Devices and IVDs

In Mexico, medical devices and in-vitro diagnostic (IVD) devices are governed by COFEPRIS, a division within the Mexican Ministry of Health
(Secretaría de Salud).

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 (Appendix II of the Supplement for Medical Devices to the Mexican Pharmacopoeia).
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Class I Class I Class II Class III

Low Risk

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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.
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Demonstrate home country approval.1 A common way to satisfy this requirement is with a
Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).
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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.
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Prepare a detailed Registration Dossier including device/manufacturing information, laboratory testing reports,
Submit application to COFEPRIS.
etc. Provide proof of compliance with quality management requirements (e.g., ISO 13485 certificate)
Application includes basic company
and/or a CE certificate.
and device information, and all
--OR--
documents must be submitted in
If your device is already registered in the US, Canada or Japan, your device may qualify for an equivalency review
English or Spanish.
process with fewer documentation requirements.1
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Depending on your product’s features and intended use, specific test reports could be required.
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In general, reports from tests performed outside Mexico according to international standards are accepted.
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All devices must follow labeling requirements found in NOM-137-SSA1-2008. Labeling and Instructions for Use must be in Spanish.
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MRH submits Registration Dossier to COFEPRIS or Third Party Reviewer2 for review, along with payment for
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registration fees. All documents must be submitted in English or Spanish.
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Certificate is issued by COFEPRIS. Registrations are valid for 5 years.

Some products will require an import permit before they may be brought into Mexico.
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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.

1
Companies without home country approval can register under a qualifying equivalency agreement. The “equivalency route” utilizes more summarized documentation. 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.
2
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 lengthen total review time by
2-4 months. Companies using the “equivalency” route cannot submit through a Third Party Reviewer.

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