How Classification Works
COFEPRIS classifies medical devices into three risk classes under the Reglamento de Insumos para la Salud and the Mexican Pharmacopoeia. Classification determines the registration route, dossier requirements, review timelines, and post-market obligations.
The three risk classes
| Class | Risk level | Examples |
|---|---|---|
| Class I | Low risk | Tongue depressors, bandages, examination gloves, simple diagnostic instruments |
| Class II | Medium risk | Syringes, blood pressure monitors, dental drills, basic IVD kits |
| Class III | High risk | Implants, pacemakers, ventilators, in vitro fertilisation equipment |
The 2025 classification reform — Annex system
The July 2025 COFEPRIS decree introduced a revised classification framework with three Annexes for low-risk devices, replacing the 2011 and 2014 exemption agreements:
| Annex | Description | Registration required? |
|---|---|---|
| Annex 1 | Low-risk devices requiring sanitary registration | Yes — streamlined process, 20-business-day target |
| Annex 2 | Low-risk devices exempt from sanitary registration | No — but GMP and technovigilance still apply |
| Annex 3 | Products not classified as health supplies | No — entirely outside COFEPRIS device regulation |
Devices previously marketed under an exemption letter that are now listed in Annex 1 must obtain full sanitary registration. COFEPRIS established a staggered three-year transition period to facilitate compliance. Check the DOF decree text for your product's specific deadline.
Classification criteria
Classification is based on:
- Degree of invasiveness (non-invasive, invasive, implantable).
- Duration of contact with the patient (transient, short-term, long-term).
- Potential physiological effect and consequences of failure.
- Whether the device incorporates a medicinal substance (affects route and regulator involvement).
- Whether it is active (requires an energy source) or passive.
Where to find your device class
- Consult the Mexican Pharmacopoeia (Farmacopea de los Estados Unidos Mexicanos) — the classification rules for medical devices are codified there.
- Check the July 2025 Annex decree in the DOF if your device may be low-risk.
- Review COFEPRIS's published guidance by device type.
- For ambiguous cases, a formal classification query can be submitted to COFEPRIS through DIGIPRiS.
IVDs — separate classification rules
In vitro diagnostic devices (IVDs) have their own classification criteria under the Reglamento de Insumos para la Salud. See IVD classification.