Clinical Evidence Requirements
COFEPRIS requires clinical evidence of safety and performance as part of the sanitary registration dossier. The depth of evidence required scales with device risk class and novelty.
General principles​
- Clinical evidence must support the intended use stated in the registration application.
- Evidence should demonstrate an acceptable benefit–risk balance for the intended patient population.
- Foreign clinical data is accepted — Mexico does not generally require clinical studies conducted specifically in Mexico.
- Evidence should be current and reflect the state of clinical knowledge.
Requirements by device class​
| Class | Expected clinical evidence |
|---|---|
| Class I | Literature review citing published data for similar devices; clinical evaluation summary |
| Class II | Clinical evaluation report; literature review; clinical study data for novel or higher-risk devices |
| Class III | Comprehensive clinical evaluation including prospective clinical study data; benefit–risk analysis |
Using foreign clinical data​
COFEPRIS accepts clinical data generated outside Mexico, including:
- Pivotal clinical studies submitted to FDA, CE/MDR, TGA, or Health Canada.
- Post-market clinical follow-up (PMCF) data from other markets.
- Published peer-reviewed literature relevant to the device and intended use.
- Registry data and real-world evidence.
Where data is from foreign studies, applicants should:
- Justify the relevance of the study population to the Mexican patient population.
- Confirm the device configuration studied is identical to the device being registered.
Clinical investigations in Mexico​
While Mexico does not routinely require locally conducted studies, sponsors wishing to conduct clinical investigations in Mexico must comply with:
- Ley General de Salud (research chapter).
- Good Clinical Practice requirements.
- Hospital ethics committee (CEI — Comité de Ética en Investigación) approval.
- COFEPRIS authorisation for device investigations involving significant risk.
See Clinical investigations in Mexico for full detail.
IVD performance evaluation​
For IVD devices, clinical evidence takes the form of performance evaluation, including:
- Analytical performance: sensitivity, specificity, precision, accuracy, linearity, limits of detection.
- Clinical performance: clinical sensitivity and specificity against a reference standard.
- Stability data: reagent stability under storage and in-use conditions.