Mexico Medical Device Regulations

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

Additional Information