COFEPRIS Mexico Medical Device and IVD Classification and Grouping
In Mexico, medical device classification determines the regulatory requirements for a specific device.
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). Edition 5.0 of the Pharmacopoeia, released in 2023, added 12 new rules to the existing 23 classification rules.
Mexico medical device classification tiers
Medical devices are classified into four tiers of increasing risk:
- 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.
Frequently
Asked Questions
How are IVDs classified in Mexico?
IVDs are regulated as a separate category of medical devices. The updated classification rules in the Pharmacopoeia expanded the rules that address IVD classification from four rules to 10. IVDs are classified as Class I, II, or III.
Do low-risk medical devices still require COFEPRIS registration?
Yes, you must still obtain a Sanitary Registration from COFEPRIS and designate a Mexico Registration Holder, even if your device is low risk. However, the registration process is much faster and the documentation requirements are minimal, such as a representation agreement, distributor list, etc.
What happens if I incorrectly group devices in a COFEPRIS registration?
If your registration application includes devices that cannot be grouped, COFEPRIS will reject your application and you will have to reapply with separate applications for the devices that cannot be grouped.
