Medical Device Classification in Mexico
The classification of medical devices is based on the potential risk they may pose to the user. According to Mexican regulations, specifically the Health Supplies Regulation (RIS), Article 83 outlines three classes:
Class I: Medical supplies that are well-known in medical practice, whose safety and efficacy are proven, and that generally are not introduced into the body.
Class II: Medical supplies that are well-known in medical practice but may vary in the material or concentration, and are typically introduced into the body for less than 30 days.
Class III: Newly developed or recently accepted medical supplies that are introduced into the body and remain there for more than 30 days.
Additionally, there is an Agreement published in the Official Gazette of the Federation (Diario Oficial de la Federación) dated December 22, 2014, supplementing the previous Agreement from December 31, 2011, which introduces a list of Low-Risk Health Supplies, classified as follows:
Low Risk: Supplies that, due to their nature, require a sanitary registration as low-risk products.
This Agreement includes two annexes:
Annex ONE – List of health supplies considered low risk for registration purposes.
Annex TWO – Products that, due to their nature, characteristics, and intended use, are not considered health supplies and therefore do not require sanitary registration.
Finally, the Appendix II (Normative) of the Medical Device Supplement provides 35 Rules as a regulatory tool to correctly classify medical devices in Mexico based on their health risk level.
Generally, these rules are divided into seven groups:
Non-invasive medical devices (4 rules)
Invasive medical devices (6 rules)
Additional rules applicable to active medical devices (7 rules)
Special rules (6 rules)
Diagnostic agents (10 rules)
Hygienic products (1 rule)
Low-risk medical devices (1 rule)
When applying classification criteria, the following guidelines must be considered:
The intended use of the medical device will govern the application of classification criteria.
If multiple rules apply to the same device based on its various intended uses or functions assigned by the manufacturer, the rule leading to the highest classification must be applied.
If a medical device is intended to be used in combination with another device, classification criteria must be applied separately to each product.
Software used to control or influence a medical device will be included within the same classification category as the device it manages.
If a medical device is not intended exclusively or primarily for a specific body part, the classification will be based on the most critical intended use.
The rules outline device characteristics related to use, activity, body contact, and duration of contact. Therefore, understanding the intended use and full specifications of your device is essential to determine the correct classification among the 35 rules.
With these tools and the regulatory framework, you can determine whether your product falls under Class I, Class II, Class III, Low Risk, or does not require sanitary registration.