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Import Licences & Distribution Authorisations

Import permits — when required​

Not all medical devices require a separate import permit from COFEPRIS:

  • Devices exempt from registration under Annex 2 of the 2025 classification decree no longer require an import permit for those products.
  • Devices requiring sanitary registration (Class I–III and Annex 1 devices) generally require confirmation of valid registration before customs clearance; some may additionally require an import permit depending on device type.
  • Devices entering Mexico for clinical investigation or evaluation require a specific import authorisation.

Verify current import permit requirements for your specific device category through COFEPRIS or your MRH, as requirements may vary.

Aviso de funcionamiento — notice of operation​

Any facility involved in the manufacturing, import, storage, or distribution of medical devices in Mexico must register with COFEPRIS through an Aviso de funcionamiento (notice of operation). This is submitted through the DIGIPRiS portal.

Required for:

  • Manufacturing facilities
  • Import facilities
  • Warehouses and distribution centres
  • MRH offices handling device registration and distribution

The notice must include the address, the legal representative, and the Responsable Sanitario.

Responsable Sanitario — Health Manager​

The Responsable Sanitario is a qualified professional (typically a pharmacist, chemist, biologist, or engineer with relevant credentials) who:

  • Is formally designated at each regulated facility.
  • Bears personal professional responsibility for compliance at that facility.
  • Must be registered with COFEPRIS.
  • Signs off on regulatory submissions and compliance activities.

Each import or distribution facility must have a designated Responsable Sanitario.

Warehouse compliance (NOM-241 Chapter 19)​

Warehouses and distribution facilities must comply with NOM-241-SSA1-2025 Chapter 19, which specifies:

  • Storage conditions (temperature, humidity, light) appropriate to each device type.
  • Segregation of quarantine, approved, and rejected stock.
  • Traceability and documentation of movements.
  • Procedures for handling returns, complaints, and suspected counterfeit or defective products.
  • CAPA processes for non-conformities.

Third-party logistics providers (contract warehouse and distribution companies) used by the MRH or importer are considered distributors under NOM-241 and must comply with all warehouse and traceability requirements. These responsibilities must be explicitly documented in a technical agreement between the MRH (or importer) and the logistics provider, specifying roles, audit rights, and incident reporting obligations.

Responsable Sanitario — Health Manager​

Personal accountability & liability ​ The Responsable Sanitario bears personal legal and professional responsibility for compliance at the facility. Key points:

Personal liability — The Responsable Sanitario can be held personally accountable by COFEPRIS, CNFV, and Mexican authorities for regulatory violations, even if they did not directly cause the breach. Professional consequences — COFEPRIS can suspend the Responsable Sanitario's registration, effectively preventing them from serving in this role at any facility in Mexico. Criminal exposure — In cases of serious harm or intentional misconduct, the Responsable Sanitario may face criminal charges under Mexican health law. Due diligence — Responsables Sanitarios should:

Maintain independent awareness of regulatory changes and facility compliance status. Document their oversight activities (inspections, training, corrective actions) to demonstrate reasonable diligence. Raise compliance concerns in writing to management and the MRH. Choosing a qualified, attentive Responsable Sanitario is critical. Avoid appointing individuals without genuine time, expertise, or authority to fulfil the role.