IVD Classification
In vitro diagnostic (IVD) devices — called agentes de diagnóstico in Mexican regulation — are classified separately from general medical devices under the Reglamento de Insumos para la Salud.
What is an IVD?​
An IVD is a product intended for the examination of specimens derived from the human body (blood, urine, tissue, etc.) to provide information about a physiological or pathological condition. This includes:
- Reagents, kits, and calibrators
- Control materials and instrument consumables
- Instruments and systems intended for IVD use
- Software intended specifically for IVD purposes
IVD risk classification​
COFEPRIS classifies IVDs based on risk to patients and public health:
| Class | Risk level | Examples |
|---|---|---|
| Class I IVD | Low risk | General chemistry reagents, non-clinical diagnostic reagents |
| Class II IVD | Medium risk | Blood glucose monitors, pregnancy tests, basic haematology |
| Class III IVD | High risk | Blood screening for infectious diseases (HIV, hepatitis), oncology markers, neonatal screening |
High-risk IVDs (Class III) attract the most stringent dossier and clinical evidence requirements, including performance evaluation data (sensitivity, specificity, clinical validation).
Registration requirements by IVD class​
All IVDs except those in Annex 2 or 3 of the 2025 classification decree require sanitary registration. Requirements include:
- Product description and intended use.
- Technical specifications — reagent composition, instrument specifications.
- Performance data — analytical and clinical validation (more extensive for Class III).
- GMP compliance — NOM-241 or ISO 13485.
- Labelling — compliant with NOM-137 in Spanish.
Equivalency route for IVDs​
IVDs approved by IMDRF/MDSAP-recognised authorities (FDA, CE-IVDR, TGA, Health Canada — the latter for Class II–IV only) are eligible for the Equivalency Route, subject to the device being identical to the approved foreign version.