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DIGIPRiS — COFEPRIS Online Portal

DIGIPRiS (Sistema Integral de Gestión de Permisos, Registros e Insumos para la Salud) is the official online platform through which all interactions with COFEPRIS are conducted for medical devices.

What DIGIPRiS is used for​

All of the following are submitted through DIGIPRiS:

  • New sanitary registration applications (standard and equivalency routes)
  • Registration renewals
  • Post-approval modifications
  • Import permits and licences
  • Aviso de funcionamiento (warehouse notice)
  • Fee payment
  • Status tracking of submitted applications

Who can access DIGIPRiS​

The Mexico Registration Holder (MRH) — the legal representative in Mexico — is responsible for accessing DIGIPRiS and managing submissions on behalf of the foreign manufacturer. Domestic manufacturers access the portal directly.

Key features​

  • Homoclave selection: The portal guides applicants through selecting the correct application mode and code (homoclave) for their device and submission type. The homoclave system was streamlined by COFEPRIS in recent reforms to reduce overlapping codes.
  • Fee payment integration: Government fees are paid through the portal at time of submission.
  • Application tracking: Status updates are visible within DIGIPRiS once submitted.
  • Document uploads: All dossier documents are uploaded in PDF format through the portal.
Pre-submission third-party review

For standard route submissions, COFEPRIS permits use of a designated pre-approving third-party agency to review the dossier before formal submission. This option is not available for the equivalency route. A successful pre-review can reduce the risk of deficiency letters and extend submission quality.

Practical tips​

  • Ensure all uploaded documents are in Spanish or are accompanied by officially certified translations.
  • Check COFEPRIS's current list of accepted homoclave codes before submitting — codes are periodically updated.
  • Keep proof of fee payment (pago de derechos) on file; this is required as part of the submission.
  • DIGIPRiS may time out during long sessions — save work frequently.