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

Classification	Examples	Risk Level
Class I Low Risk		Low
Class I	Simple surgical instruments, tongue depressor	Moderate-Low
Class II	Digestive catheters, infusion pumps, and powered wheelchairs	Moderate
Class III	Dialyzers, and orthopaedic implants	High

Premarket Approval Process

Class I Low Risk	Class I	Class II	Class 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

Validity	Five years
Postmarket Surveillance	Must report adverse events and device recalls
Language	All documents must be translated into spanish.
Expected Time	Class 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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