Mexico Medical Device Regulations

Regulatory Agency

Mexican Federal Commission for Protection against Sanitary Risk (COFEPRIS) is responsible to regulate medical devices in Mexico.

Medical Device Definition

Medical Device: instrument, apparatus, utensil, machine, including the software for its operation, product or implantable material, diagnostic agent, material, substance, or similar product, to be used, alone or in combination, directly or indirectly in human beings; with any of the following purposes of use:

Diagnosis, prevention, surveillance or monitoring, and help in the treatment of diseases;
Diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or aid in the healing of an injury;
Substitution, modification, or support of the anatomy or a physiological process;
Life support;
Conception control;
Disinfection of medical devices;
Disinfectant substances;
Provision of information through in vitro examination of samples taken from the human body for diagnostic purposes;
Devices that incorporate tissues of animal and/or human origin and;
Devices used in in vitro fertilization and assisted reproductive technologies;

Medical devices include health supplies in the following categories: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, dental supplies, surgical and healing materials, and hygienic products.

Medical Equipment: apparatus, accessories, and instruments for specific use, intended for medical or surgical care or exploration, diagnosis, treatment, and rehabilitation of patients, as well as those for biomedical research activities. Note: Medical equipment requires calibration, maintenance, repair, de-installation, and final disposal, as well as user training. It is used for monitoring, diagnosing, and treating disease or rehabilitation after illness or injury; it may be used alone or in combination with any accessory, consumable, or other medical equipment. Medical equipment excludes implantable, disposable, or single-use medical devices.

Medical Device Classification System

International Classification	Risk Level	Definition	Examples
Class I	Low risk	Well-known in medical practice; verified security and efficacy. Do not enter the body.	Disposable gloves, Thermometers, Blood pressure monitors, Surgical masks
Class II	Medium risk	Well-known in medical practice; may have variations in their materials; may be introduced into the body remaining less than thirty (30) days.	Syringes, Wheelchairs, Infusion pumps, Glucose meters
Class III	High Risk	Recently accepted in medical practice, or introduced into the body remaining more than thirty (30) days.	Artificial heart valves, Pacemakers, implanted defibrillators, Silicone breast implants

Regulatory Approval Process

Classification	Approval procedure
Class I	Prepare a detailed Registration Dossier including draft labeling and Instructions For Use. Provide proof of compliance with quality management requirements and/or a CE certificate/ If your device is already registered in the US, Canada or Japan, then your device may qualify for an equivalency review process with fewer documentation requirements. Make the payment and include the receipt and 2 copies in the dossier. Along with the dossier, include a copy of Instructions For Use and Field Safety Corrective Action report. Submit application to COFEPRIS. All devices must follow labeling requirements found in NOM-137- SSA1-2008. Labeling and Instructions For Use must be in Spanish. Certificate issued by COFEPRIS and proof of registration is published on COFEPRIS website.
Class II
Class III
Notes: - The approval process for high-risk medical devices (Class III) may be more extensive and may involve additional clinical trials or evaluations. The length of time it takes to obtain approval for a medical device in Mexico can vary depending on the complexity of the device and the amount of information required for review.

Additional Information

Approval timeline	Class I: 30 days, Class II: 35 days, Class III: 60 days
License validity period	5 Years
Import	Products may apply for an import permit to market them in Mexico.
Fees	Class I: 15,206 MXN Class II: 22,302 MXN Class III: 28,394 MXN

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