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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:

ClassRisk levelExamples
Class I IVDLow riskGeneral chemistry reagents, non-clinical diagnostic reagents
Class II IVDMedium riskBlood glucose monitors, pregnancy tests, basic haematology
Class III IVDHigh riskBlood 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-recognised authorities (FDA, CE-IVDR under EU In Vitro Diagnostic Regulation, TGA, Health Canada) are eligible for the Equivalency Route, subject to the IVD being identical in design, performance characteristics, and intended use to the approved foreign version.

IVDs listed in Annex 2 or 3 of the July 2025 COFEPRIS decree are exempt from sanitary registration. Check the DOF decree to confirm your IVD's Annex status before proceeding with full registration.