Special Device Types
Combination products
A combination product (insumo combinado) is a product that combines a medical device with a medicinal substance (e.g., a drug-eluting stent, a drug-device kit). In Mexico:
- The primary mode of action determines the lead regulatory pathway.
- If the primary mode is the device component, COFEPRIS device division leads.
- If the primary mode is pharmacological, the pharmaceutical division leads, with the device component assessed as an accessory.
- Consultation with COFEPRIS is strongly recommended early in development.
Software as a Medical Device (SaMD)
See Software & SaMD classification and Digital Health & SaMD.
IVD medical devices
In vitro diagnostic devices follow dedicated classification rules. See IVD classification.
Custom-made devices
Custom-made devices (dispositivos a medida) are manufactured specifically for an individual patient based on a prescription or order from a qualified health professional. Requirements:
- Generally exempt from standard sanitary registration.
- Must still comply with GMP principles.
- The manufacturer must maintain records for each custom device produced.
- Must carry a label identifying it as a custom device.
See Custom-made device pathway.
Single-use devices
Single-use devices (SUDs) must be labelled accordingly under NOM-137. Reprocessing of SUDs for clinical reuse is a sensitive regulatory area — COFEPRIS has not published explicit reprocessing regulations equivalent to EU or FDA frameworks. Manufacturers should label clearly and monitor COFEPRIS guidance updates.
Export-only devices
Devices manufactured in Mexico exclusively for export may be eligible for reduced domestic registration requirements. However:
- Domestic production still requires a valid Aviso de funcionamiento and GMP compliance (NOM-241).
- A Certificate of Free Sale (CFS) for the export market can be requested from COFEPRIS for use in foreign registrations.
- Devices not intended for the Mexican market must be clearly labelled as export-only.