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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 used by the MRH or importer carry the same compliance obligations — these responsibilities should be reflected in the technical agreement.