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.