Class I · II · III — Overview
Class I — Low risk
Class I devices present the lowest risk to patients and users. They are generally non-invasive, non-active, and have limited patient contact.
Characteristics:
- External use or minimal contact with intact skin or mucous membranes.
- No significant biological effect.
- Failure unlikely to cause serious harm.
Examples: examination gloves (non-sterile), tongue depressors, bandages, non-sterile gauze, basic examination instruments, non-powered hospital beds.
Regulatory requirements:
- Sanitary registration required (unless listed in Annex 2 or 3 of the 2025 decree).
- Streamlined submission — 20 business days July 7, for Annex 1 devices COFEPRIS targets for review and approval.
- GMP compliance with NOM-241.
- Technovigilance unit required.
Registration fee: MXN 16,499 (~USD 930) for Class I and Class I Low Risk.
Class II — Medium risk
Class II devices present moderate risk. They may be invasive, active, or have sustained patient contact but are well-understood in medical practice.
Characteristics:
- May be introduced into the body (but not permanently implanted).
- May be active (require an energy source).
- Risk is manageable with standard GMP and clinical evidence.
Examples: syringes, blood pressure monitors, urinary catheters, dental drills, basic IVD diagnostic kits, orthopaedic braces.
Regulatory requirements:
- Full sanitary registration.
- Standard or equivalency route available.
- Technical dossier with design, clinical evidence, and GMP documentation.
- Review timelines: 30–60 days (standard route).
Registration fee: MXN fees for Class II (check current COFEPRIS fee schedule).
Class III — High risk
Class III devices present the highest risk. They are typically implantable, life-sustaining, or life-supporting.
Characteristics:
- Long-term or permanent implantation in the body.
- Life-sustaining or life-supporting function.
- Failure likely to cause serious harm or death.
- No sufficient clinical history to characterise risk with standard controls alone.
Examples: pacemakers, cardiac stents, total hip prostheses, ventilators, dialysis machines, in vitro fertilisation equipment, neurostimulators.
Regulatory requirements:
- Full sanitary registration — most comprehensive dossier requirements.
- Clinical evidence of safety and efficacy.
- Full GMP compliance (ISO 13485 or equivalent).
- Review timelines: 60–180 days (standard route); equivalency route available if prior IMDRF approval exists.
- Most stringent technovigilance obligations.
Comparison table
| Class I | Class II | Class III | |
|---|---|---|---|
| Risk level | Low | Medium | High |
| Clinical evidence | Minimal / literature | Required | Comprehensive |
| GMP (NOM-241) | Yes | Yes | Yes |
| Equivalency route | Yes | Yes | Yes |
| Renewal period (first) | 5 years | 5 years | 5 years |
| Subsequent renewal | Up to 10 years | Up to 10 years | Up to 10 years |
Related pages
- How classification works
- Low-risk devices — Annexes 1–3
- Standard Registration Route
- Equivalency Route
Replace 'MXN fees for Class II (check current COFEPRIS fee schedule).' with a specific fee reference or note directing users to the Fees & Fee Calculator Reference page. Example: 'MXN 24,749 (~USD 1,395) — verify current fee via the annual Ley Federal de Derechos in the DOF (see Fees & Fee Calculator Reference).'