Custom-Made Device Pathway
A custom-made device (dispositivo a medida) is a device manufactured specifically for an individual patient based on a written prescription or order from a qualified health professional (physician, dentist, etc.), tailored to that patient's unique anatomical characteristics or clinical needs.
Exemption from standard registration
Custom-made devices are generally exempt from the standard COFEPRIS sanitary registration requirement, as they are made for a specific patient rather than for general commercial supply.
This exemption applies when:
- The device is manufactured for a named individual patient.
- It is based on a written prescription from a qualified health professional.
- It is not placed on the broader market (i.e., not available for general sale).
Applicable requirements
Despite the registration exemption, custom-made devices must still comply with:
- GMP principles (NOM-241-SSA1-2025) — the manufacturer must operate a quality system appropriate to the scale and risk of their operations.
- Labelling — the device must carry a label identifying it as a custom-made device for a specific patient.
- Traceability — records linking the device to the patient prescription and manufacturing details must be maintained.
- Technovigilance — adverse events related to custom-made devices should still be reported to CNFV.
What constitutes a custom-made device?
The exemption does not apply to:
- Devices manufactured using standardised production methods, even if adapted in size or dimension.
- Devices produced in serial runs for multiple patients (these require standard registration).
- Devices that are regularly available but chosen for a specific patient — selection is not customisation.
Common examples in Mexico
- Dental prostheses and orthotics made to individual impressions.
- Orthopedic braces fabricated to patient measurements.
- Hearing aids custom-fitted to an individual.
- Cranial implants made from patient-specific imaging data.