COFEPRIS Classification: Classes I, II & III

Mexico medical device classification criteria

Mexico medical device classification is determined by a range of factors and product characteristics, such as the product's intended purpose, invasiveness, and duration of use. COFEPRIS imposes pre- and post-market regulatory requirements as the risk level increases to ensure the safety and efficacy of the product. 
 


Mexico’s medical device classification rules are found in Annex II of the Supplement of Medical Devices of the Mexican Pharmacopoeia. COFEPRIS classification rules reference the International Medical Device Regulators Forum (IMDRF), EU Medical Devices Directive MDD 93/42/EEC, and the EU Medical Devices Regulation 2017/745 (MDR). Use the current FEUM medical-device supplement and applicable official lists; document the exact rules and edition used.

Mexico medical device classification tiers

Mexico uses three principal risk classes, I, II and III. Low-risk treatment and exemption lists require a separate product-specific check:

• Class I (Low Risk): Devices that pose minimal risk to patients or users. Examples include bandages, non-invasive diagnostic devices, and tongue depressors.
• Class I: Devices that do not directly affect vital functions but may present some risk to patients.
• Class II: Devices with moderate risk that require greater regulatory control. Examples include surgical instruments, syringes, and contact lenses.
• Class III: Devices with high-risk potential that directly affect vital functions or pose significant risks to patients. Examples include cardiac pacemakers, orthopedic implants, and life-supporting equipment.

Mexico medical device grouping

Medical device family grouping allows you to combine similar devices under the same registration, which can minimize the expense and workload of COFEPRIS registration. Medical device grouping is permitted under these basic principles:

• The products are manufactured by the same manufacturer or by its subsidiaries.
• The generic product has the same commercial or distinctive name, same indication or purpose of use.
• Presentations intended for distribution in different commercial chains may be included in the same record, as long as the same commercial name is maintained.
• Same technology, formula, or ingredients.

Class, exemption and grouping are separate decisions

Examples do not classify an individual device. A shared brand is insufficient for family grouping, and foreign class names cannot simply be copied. Connect the result to registration, Spanish labeling and lifecycle controls.