MRH Obligations
The Mexico Registration Holder (MRH) bears substantial ongoing obligations under Mexican law. These are not merely administrative duties — the MRH is legally accountable for registered devices in Mexico.
Registration & submission management
- Submit new registration applications, renewals, and post-approval modifications via DIGIPRiS.
- Maintain the sanitary registration in active, valid status (renew before expiry).
- Ensure all modifications to the device, labelling, manufacturer, or supply chain are notified to or approved by COFEPRIS as required.
Technovigilance
Under NOM-240-SSA1-2012, the MRH must:
- Establish and maintain a technovigilance unit with trained personnel and documented procedures.
- Receive adverse event reports from distributors and healthcare facilities.
- Assess and report serious adverse events to CNFV within mandated timeframes.
- Submit trend reports where patterns of incidents emerge.
- Coordinate Field Safety Corrective Actions (FSCAs) when required.
- Submit a Technovigilance Report as part of the five-year registration renewal.
Distributor management
Under NOM-241-SSA1-2025, the MRH must:
- Enter into a technical agreement (acuerdo técnico) with each distributor in Mexico, defining roles, responsibilities, and quality expectations.
- Ensure distributors maintain appropriate storage conditions and distribution records.
- Receive incident notifications from distributors within agreed timeframes.
GMP oversight
- Ensure the manufacturer maintains GMP compliance throughout the registration lifecycle.
- Be prepared to provide updated GMP evidence at renewal.
Communication with COFEPRIS
- Respond to COFEPRIS correspondence, deficiency letters, and inspection requests.
- Represent the manufacturer in all regulatory matters before COFEPRIS.
Record-keeping
- Maintain records of all regulatory submissions, approvals, and correspondence.
- Maintain records of adverse events, FSCAs, and technovigilance activities.
- Keep distribution records traceable per NOM-241.