To determine the regulatory pathway and required documents for the commercialization of a medical device (MD), you must first ensure that your product actually qualifies as a medical device. Then, you will need to correctly classify it based on its health risk.
According to the definition provided in NOM-241-SSA1-2021, a medical device is generally described as an implant, material, substance or similar product, utensil, diagnostic agent, software, instrument, apparatus, or machine intended for use in diagnosis, prevention, surveillance, monitoring, or as an aid in the treatment of a disease or injury.¹
If your product’s intended use aligns with this definition, it can be considered a medical device.
The next step is to classify the device based on its risk level, as described in Article 83 of the Health Supplies Regulation, which establishes the following classes:
Class I: Well known in medical practice, proven safety and efficacy, and generally not introduced into the human body.
Class II: Also well known in medical practice, may have variations in materials or concentration, and are generally introduced into the body for less than thirty days.
Class III: New or recently accepted in medical practice, or introduced into the body and remain there for more than thirty days.
Additionally, Supplement 5.0 for Medical Devices of the Mexican Pharmacopeia (FEUM) introduces a further classification:
Class I – Low Risk: Devices with proven safety and efficacy supported by technical and scientific information, whose intended use does not require them to be sterile, does not involve measurement or life support functions, and does not pose unacceptable risks to health.
To ensure accurate classification, you can refer to Appendix II of the same Supplement, which describes 35 classification rules based on the following criteria:
Degree of invasiveness
Duration of use in the body
Use of energy
Diagnostic agents
Hygienic products
Special rules
These rules are an excellent tool to help you correctly classify your medical device and, in doing so, submit the appropriate documentation and pay the correct fee for your sanitary registration application for commercialization purposes.
Do you have questions?