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Mexico Medical Device Regulations

Agency
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:
  • 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;
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.
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
Approval Process
Classification Approval procedure Approval procedure
Class I
  • The manufacturer or importer of the medical device must register the device with COFEPRIS.
  • Market Authorization:- If the device is approved by COFEPRIS, the manufacturer or importer will be issued a market authorization, which allows them to commercially distribute the device in Mexico.
  • The manufacturer or importer of the medical device must register the device with COFEPRIS. This involves submitting detailed information about the device, including its specifications, intended use, and clinical data.
  • COFEPRIS will conduct a technical review of the device to ensure it meets all applicable standards and regulations. This may include conducting laboratory tests or evaluating clinical data.
  • Market Authorization:- If the device is approved by COFEPRIS, the manufacturer or importer will be issued a market authorization, which allows them to commercially distribute the device in Mexico.
  1. Request an appointment on the page www.gob.mx/cofepris.
  2. Show up for your appointment on the day and time indicated, with the File referring to your procedure and the payment of rights.
  3. Exchange the folio number of your appointment for the corresponding shift.
  4. Wait until they assign you a service window to enter the procedure.
  5. Receive proof of the sealed procedure.
  6. Check the availability of your procedure on the page www.gob.mx/cofepris or by calling 800 033 50 50.
  7. As soon as the application is available, pick up the resolution in exchange for the original receipt.
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:-  1 to 3 months, Class II & III :- 3 to 9 months
License validity period 5 Years
Import Products may apply for an import permit to market them in Mexico.
Fees Class I: 14,576 MXN Class II: 21,378 MXN Class III: 27,209 MXN
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