Compassionate Use & Emergency Access
Compassionate use and emergency authorisation pathways in Mexico for medical devices that have not yet received COFEPRIS sanitary registration.
Clinical Investigations in Mexico
Requirements for conducting clinical investigations of medical devices in Mexico — COFEPRIS authorisation, ethics committee approval, and GCP requirements.
Custom-Made Device Pathway
Regulatory requirements for custom-made medical devices in Mexico — exemption from standard sanitary registration and applicable GMP obligations.