Mexican Federal Commission for Protection against Sanitary Risk (COFEPRIS) is responsible to regulate medical devices in Mexico.
Medical Device Definition
A medical device in Mexico is any instrument, apparatus, utensil, machine, software, 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:
And their intended use is not through pharmacological, immunological, or metabolic mechanisms. However, they can be assisted by these means to achieve their function. Medical devices include health supplies of the following categories: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, supplies for dental use, surgical materials, healing materials, and hygienic products.
- Diagnosis, prevention, surveillance or monitoring, and/or aid 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/or
- Devices used in in vitro fertilization and assisted reproductive technologies;
Medical Device Classification System
||Well-known in medical practice; verified security and efficacy. Do not enter the body.
||Disposable gloves, Thermometers, Blood pressure monitors, Surgical masks
||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
||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
||Class I:- 1 to 3 months, Class II & III :- 3 to 9 months
|License validity period
||Products may apply for an import permit to market them in Mexico.
||Class I: 14,576 MXN
Class II: 21,378 MXN
Class III: 27,209 MXN