Medical Devices at a glance: Find out if your product is a Medical Device

New products and technologies are available every day that are fundamental components in the Health Area and it is important to know if these fall within the definition of a Medical Device (MD) described in the Supplement to the Pharmacopoeia of the United Mexican States (FEUM), since its commercialization is regulated in Mexico.

So, how do you know if your product is a medical device?

Below you can find the definition of Medical Device described in the FEUM Supplement, where if the indication for use of your product is within the purposes described in the definition, rest assured that your product is a MD and you will need to register it to the COFEPRIS.

MEDICAL DEVICE: It is any instrument, apparatus, utensil, machine, including the software for its operation, implantable product or material, diagnostic agent, material, substance or similar product, to be employed, 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 ancillary to the treatment of disease;
  • Diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or aid in the healing of an injury;
  • Substitution, modification, or support of anatomy or a physiological process;
  • Life support;
  • Conception control;
  • Disinfection of medical devices;
  • Disinfecting substances;
  • Provision of information through an in vitro examination of samples taken from the human body, for diagnostic purposes;
  • Devices incorporating tissues of animal and/or human origin;
  • Devices used in In Vitro fertilization and assisted reproductive technologies;

And whose primary purpose of use is not through pharmacological, immunological or metabolic mechanisms, however, they can be assisted by these means to achieve their function.

If you got this far and you think your product is indicated for some of the aforementioned purposes, but still have doubts, come to us, at GMVR we support you to analyze whether your product falls within the definition of MD, or if you already have the certainty that your product is a MD, we help you to carry out the Sanitary Registration process.

Don't miss our next blog topic, where we will discuss in detail the categories of medical devices, as well as their classification based on health risk.