Mexico Medical Device Regulations

Agency
All medical devices are regulated by Comision Federal para la Proteccion contra Riegos Sanitarios (COFEPRIS) Secretaria de Salud
Medical Device Definition
A medical device is a substance, mixture of substances, equipment, apparatus, instruments (including software needed for proper use or application), used alone or in combination in diagnosing, monitoring, or prevention of disease in humans or auxiliary in the treatment and disability, as well as employees in the replacement, correction, restoration or modification of the anatomy or physiological processes. Guidelines, 1.1.
Classification of Medical Device
ClassificationExamplesRisk Level
Class I Low RiskLow
Class ISimple surgical instruments, tongue depressorModerate-Low
Class IIDigestive catheters, infusion pumps, and powered wheelchairsModerate
Class IIIDialyzers, and orthopaedic implantsHigh
Premarket Approval Process
Class I Low RiskClass IClass IIClass III
Appoint a Mexico Registration Holder (MRH) who will coordinate device submissions. This may be a distributor or third party company, but registration holder controls device registration and transferring registration is difficult and time consuming. Ensure your registration holder is long term.
Demonstrate home country approval through Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).
Device must comply with ISO 13485 or equivalent in another country . No audit will be performed.
Must submit basic device information.Submit registration dossier, which should include safety information, testing reports, clinical trial data. Approval from recognized country (Japan, Canada, or United States) may be leveraged in order to expedite approval.
if device is approved COFEPRIS will issue certificate and post confirmation of device registration on Ministry of Health website.
Additional Information
ValidityFive years
Postmarket Surveillance Must report adverse events and device recalls
LanguageAll documents must be translated into spanish.
Expected TimeClass I Low Risk: 1-3 months All other devices: Equivalency from recognized country review: 6-8 months. Standard review: 4-10 months.
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