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Who Needs to Comply?

Every party in Mexico's medical device supply chain has regulatory obligations under the Reglamento de Insumos para la Salud and the applicable NOMs. The key roles are defined below.

Domestic manufacturers​

Mexican manufacturers must:

  • Hold a sanitary registration (registro sanitario) for each device they manufacture and market.
  • Comply with NOM-241-SSA1-2025 (GMP) and maintain a certified or compliant quality management system.
  • Establish a technovigilance unit under NOM-240-SSA1-2012.
  • Submit adverse event reports to COFEPRIS/CNFV within mandated timeframes.
  • Renew registration every 5 years (subsequent renewals may be granted for up to 10 years from January 2026).

Foreign manufacturers​

Foreign manufacturers cannot hold a Mexican sanitary registration directly. They must appoint a Mexico Registration Holder (MRH) — a legally constituted Mexican entity — to act on their behalf. The MRH holds the registration and manages all regulatory interactions with COFEPRIS.

See Mexico Registration Holder for full detail.

Mexico Registration Holder (MRH)​

The MRH is the pivotal role for foreign market access. Key obligations:

  • Hold the sanitary registration in Mexico.
  • Submit and manage applications, renewals, and modifications via DIGIPRiS.
  • Operate a technovigilance unit.
  • Report adverse events to CNFV on behalf of the manufacturer.
  • Manage distributor technical agreements (required under NOM-241).
Choosing your MRH carefully

The MRH legally owns your registrations. Changing MRH requires a formal transfer process that can take months. Many manufacturers use an independent regulatory firm rather than their commercial distributor to decouple regulatory and commercial relationships.

Importers​

Importers of medical devices must:

  • Ensure the device has valid COFEPRIS sanitary registration (or is legitimately exempt).
  • Hold the relevant import permit where required.
  • Comply with the Aviso de funcionamiento (notice of operation) for their storage facility.
  • Maintain distribution records and traceability.
  • Report adverse events to the MRH for onward submission to CNFV.

Distributors​

Distributors must:

  • Verify that devices they handle carry valid COFEPRIS registration.
  • Comply with NOM-241 storage and distribution requirements.
  • Maintain a technovigilance unit and notify the MRH of any adverse incidents.
  • Hold an Aviso de funcionamiento for their warehouse, including a Responsable Sanitario (Health Manager).

Healthcare facilities​

Hospitals, clinics, and laboratories are required to:

  • Use only registered devices in clinical settings.
  • Report device-related adverse events to CNFV.
  • Maintain a technovigilance unit where applicable.