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Fees & Fee Calculator Reference

COFEPRIS charges mandatory government fees (derechos) for all medical device registration applications and renewals. Fees are set annually by the Ley Federal de Derechos (Federal Rights Law) and are updated each year. The figures below are a reference — always verify current fees before submitting.

New registration fees (2025 reference)​

Device typeFee (MXN)Approx. USD
Class I Low Risk / Annex 1MXN 16,499~USD 930
Class IMXN 16,499~USD 930
Class IIVerify current Ley Federal de Derechos—
Class IIIVerify current Ley Federal de Derechos—

Renewal fees (2025 reference)​

Device typeRenewal fee (MXN)Approx. USD
Class I Low Risk / Class IMXN 12,374~USD 700
Class IIMXN 18,149~USD 1,027
Class IIIMXN 23,098~USD 1,307

When fees are paid​

Fees are paid through the DIGIPRiS portal at the time of application submission. Proof of payment (comprobante de pago) is a required document in the submission package.

How to verify current fees​

  1. Access the current Ley Federal de Derechos — published in the DOF annually (typically in December for the following year).
  2. Search for provisions relating to COFEPRIS / sanitary registration / medical devices (dispositivos médicos).
  3. Cross-reference with the COFEPRIS website for any in-year updates.

Third-party resources such as Pure Global's fee calculator and similar tools provide indicative figures and are updated periodically — useful for planning purposes, but always verify the official source before submitting.

Fee considerations for budgeting​

  • Fees are per product — each distinct device (by class and model) requires a separate registration and fee payment.
  • A portfolio of devices across multiple classes can represent significant total fees.
  • Renewal fees are lower than new registration fees.
  • MRH service fees (regulatory consulting or local representative services) are separate commercial charges paid to the MRH provider, not to COFEPRIS.