Compassionate Use & Emergency Access
Mexico's regulatory framework provides limited mechanisms for accessing unregistered medical devices in exceptional circumstances. These pathways exist alongside — not instead of — the standard sanitary registration process.
Compassionate use (uso compasivo)
Compassionate use allows patients with serious, life-threatening, or debilitating conditions to access an unregistered medical device when:
- No satisfactory registered alternative exists.
- The device has demonstrated sufficient evidence of safety and likely benefit.
- The treating physician and institution support the use.
Process
- The treating physician or institution applies to COFEPRIS for authorisation.
- Documentation of the patient's condition, the absence of alternatives, and evidence of the device's safety and benefit is required.
- COFEPRIS evaluates on a case-by-case basis.
- Authorisation is patient-specific and does not constitute marketing approval.
MRH involvement
Even for compassionate use, a local representative (MRH or authorised importer) is typically required to facilitate the importation of the unregistered device into Mexico.
Emergency authorisations
In situations of public health emergency, COFEPRIS may issue emergency authorisations for unregistered devices — similar to FDA's Emergency Use Authorization (EUA) or EU's emergency exemption mechanisms. These were deployed during the COVID-19 pandemic.
Emergency authorisations:
- Are time-limited.
- Are revoked when the emergency ends or a standard registration is granted.
- Do not constitute permanent market authorisation.
Named-patient / patient-specific supply
Similar to compassionate use, a named-patient authorisation may be granted for a specific identified patient where:
- The device is the only viable option for that patient.
- The treating physician takes responsibility.
- COFEPRIS grants a specific import authorisation.
This pathway is distinct from a full sanitary registration and cannot be used as a route to market for commercial supply.