Regulatory Authority's official website link:https://www.gob.mx/cofepris
Database link: https://www.gob.mx/cofepris/documentos/registros-dispositivos-medicos
Ley General de Salud
| Device Classification | Initial Registration Fee (MXN) | Renewal / Extension Fee | Name Change / Corporate Modification Fee |
|---|---|---|---|
| Class I Low‑Risk | 16,499 | 75% of base fee → 12,374 | 50% of base fee → 8,249 |
| Class II Medium‑Risk | 24,198 | 75% of base fee → 18,149 | 50% of base fee → 12,099 |
| Class III High‑Risk | 30,798 | 75% of base fee → 23,098 | 50% of base fee → 15,399 |
A: When registering in Mexico, the product labels and instructions must be in Spanish. Label content should include product name, model, instructions for use, warning information, expiration date (if applicable), manufacturer information, etc.
A: If the design, manufacturing process and intended use of medical devices are changed, it is necessary to evaluate the impact of the change on product safety and effectiveness in a timely manner, and submit a change application to the Mexican health regulatory authority, and the change can be implemented after approval.
A: Five years.
A: Sure. Prior to the expiration of the registration certificate, the manufacturer is required to submit a renewal application to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). Renewal applications usually need to be initiated six months prior to the expiration date to ensure timely acquisition of a new registration certificate.