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Registration Renewal

COFEPRIS sanitary registrations are valid for 5 years and must be renewed before expiry. From January 2026, COFEPRIS has the authority to grant subsequent renewals (second renewal and beyond) for periods of up to 10 years, significantly reducing the long-term renewal administrative burden for devices with no compliance issues. This applies only to devices that have completed their first 5-year renewal without safety concerns or significant modifications.

Renewal types​

First renewal​

The first renewal (5 years after initial registration) requires the most comprehensive documentation:

  • Full GMP compliance evidence (updated ISO 13485 certificate or NOM-241 compliance documentation).
  • Technovigilance Report covering all adverse incidents, safety actions, and device usage over the 5-year registration period.
  • Updated labelling (if changed).
  • Updated technical information (if the device has changed — changes requiring prior approval must already be approved before renewal).
  • Proof of renewal fee payment.

Subsequent renewals (from January 2026)​

Second and subsequent renewals require a reduced documentation package, provided:

  • The device has remained compliant and unchanged.
  • No outstanding regulatory issues exist.
  • Fees are paid.

COFEPRIS may grant subsequent renewals for periods of up to 10 years — a significant reduction in the ongoing administrative burden.

Renewal fees​

Device classRenewal 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

The Technovigilance Report​

The Technovigilance Report is a key renewal document. It must include:

  • Device identification details (name, model/catalogue, registration number, homoclave, risk class).
  • Software version (if applicable).
  • Manufacturer and distributor information.
  • All adverse incidents reported to CNFV during the past 5 years — counts and descriptions of serious and non-serious incidents.
  • Annual units sold and estimated patient exposure.
  • Market duration.
  • Any safety alerts or FSCAs taken.
Submit 3 months early

Submit the renewal application at least 3 months before the registration expiry date to allow sufficient time for COFEPRIS review and avoid any gap in market authorisation.

Renewal process​

  1. Prepare the renewal dossier (technovigilance report, GMP evidence, labelling).
  2. Submit via DIGIPRiS under the appropriate renewal homoclave.
  3. Pay the renewal fee.
  4. Respond to any COFEPRIS queries.
  5. Receive renewed sanitary registration with updated expiry date.

Lapsed registrations​

If a registration lapses (expires without renewal), the device may no longer be lawfully sold in Mexico. The MRH would need to apply for a new registration — not a renewal — which requires a full application.

First renewal​

Impact of mid-cycle modifications on renewal ​ If your device or labelling has changed during the 5-year registration period, the renewal dossier must reflect these changes:

Updated labelling — Submit the current label and IFU as they appear on devices marketed during the renewal period (not the original label from registration). Updated technical information — If manufacturing site, supply chain, or device design changed, provide updated documentation (ISO 13485 certificates, design controls, risk management files). Approved vs. non-approved changes — Any modifications requiring prior COFEPRIS approval (per DIGIPRiS modification rules) must be approved before renewal is submitted. A renewal application cannot be used to gain approval for pending changes. Technovigilance Report implications — Ensure the Technovigilance Report reflects which incidents occurred before and after any design or manufacturing changes, as this demonstrates whether changes were effective in mitigating identified risks. If renewal documentation reveals unapproved changes, COFEPRIS may request a compliance letter or formal amendment before granting renewal, potentially delaying approval.