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Clinical Investigations in Mexico

Clinical investigations of medical devices in Mexico are governed by the Ley General de Salud (specifically its chapter on health research), Mexican Good Clinical Practice (GCP) requirements, and COFEPRIS oversight.

When a clinical investigation requires COFEPRIS authorisation​

COFEPRIS authorisation for a device clinical investigation is generally required when:

  • The device is unregistered in Mexico and is being investigated for safety and performance.
  • The investigation involves significant risk to participants.
  • The device is a Class III device or any device implanted or used invasively in an investigational context.

Lower-risk studies using already-registered devices in their approved intended use may not require COFEPRIS investigation authorisation, but ethics committee review is still required.

Ethics committee approval​

All clinical investigations in Mexico involving human subjects require approval from a CEI (Comité de Ética en Investigación — Research Ethics Committee) constituted at the investigating institution and registered with COFEPRIS's National Health Research Commission (CONBIOÉTICA or equivalent).

The CEI reviews:

  • Scientific validity and design of the investigation.
  • Benefit–risk balance.
  • Informed consent process and documentation.
  • Participant selection and protection of vulnerable populations.

Device import for investigation purposes​

Devices imported solely for clinical investigation purposes require a specific import authorisation from COFEPRIS — separate from a sanitary registration. This authorisation is tied to the specific investigation and quantities approved.

Documentation requirements​

A clinical investigation application to COFEPRIS typically includes:

  • Investigational plan (protocol).
  • Investigator brochure or device description dossier.
  • Evidence of CEI approval.
  • Informed consent forms.
  • GMP compliance evidence for the investigational device.
  • Investigator and site qualifications.

GCP requirements​

Mexico follows Good Clinical Practice principles aligned with ICH E6 and the Ley General de Salud research provisions. Key requirements:

  • Informed consent in Spanish.
  • Adverse event reporting to COFEPRIS and the CEI.
  • Data integrity and source document traceability.
  • Regulatory compliance monitoring (sponsor oversight).

Using Mexican clinical data for registration​

Data from clinical investigations conducted in Mexico can be included in COFEPRIS registration dossiers. However, most manufacturers use foreign clinical data, which COFEPRIS accepts for registration purposes (see Clinical evidence requirements).