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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.

Distributor management​

Liability & contractual safeguards ​ While the MRH bears ultimate regulatory responsibility for all registered devices, including those distributed by third parties, you can limit exposure through your technical agreement:

Ensure the technical agreement includes indemnification clauses protecting the MRH from distributor misconduct. Define clear audit rights — reserve the right to conduct unannounced inspections of distributor facilities. Specify distributor obligations regarding storage, handling, record-keeping, and incident reporting with measurable compliance standards. Require distributors to maintain product liability insurance naming the MRH as additional insured. Include termination clauses allowing exit without cause on short notice (30–60 days) if needed. Despite contractual protections, COFEPRIS will hold the MRH accountable for distributor compliance failures discovered during inspections. Monitor your distributors actively and document all oversight activities.