Registration Fees & Timelines
COFEPRIS charges mandatory government fees (derechos) for sanitary registration applications and renewals. Fees are assessed per product and vary by device class.
New registration fees (one-time)​
| Device class | Fee (MXN) | Approx. USD |
|---|---|---|
| Class I Low Risk / Annex 1 | MXN 16,499 | ~USD 930 |
| Class I | MXN 16,499 | ~USD 930 |
| Class II | Contact COFEPRIS / see current fee schedule | — |
| Class III | Contact COFEPRIS / see current fee schedule | — |
COFEPRIS fees are set by the annual Ley Federal de Derechos (Federal Rights Law) and may be updated each year. Always verify current fees on the COFEPRIS website or through DIGIPRiS before submitting. The figures above are approximate and may have changed.
Renewal fees​
| Device class | Renewal fee (MXN) | Approx. USD |
|---|---|---|
| Class I Low Risk / Class I | MXN 12,374 | ~USD 700 |
| Class II | MXN 18,149 | ~USD 1,027 |
| Class III | MXN 23,098 | ~USD 1,307 |
Review timelines​
| Route & class | Target review period |
|---|---|
| Equivalency route (all classes) | 30 working days |
| Standard route — Annex 1 / Class I | 20 business days |
| Standard route — Class I | 20–30 business days |
| Standard route — Class II | 30–60 business days |
| Standard route — Class III | 60–180 business days |
Actual timelines depend on COFEPRIS workload and the completeness of the submitted dossier. Deficiency letters (prevenciones) pause the clock — applicants must respond within the specified period.
Payment process​
Fees are paid through the DIGIPRiS portal at the time of submission. Proof of payment (pago de derechos) must be included as part of the application package.