🇲🇽
Mexico Medical Device Registration Fees
COFEPRIS government fees for 2025
MXN 15,896
Low Risk Min
MXN 29,673
High Risk Max
COFEPRIS
Authority
2025-09-17
Last Updated
Mexico (COFEPRIS) Fee Overview
Mexico (COFEPRIS) charges per-product registration fees ranging from MXN 15,896 (~$800) for Class I to MXN 29,673 (~$1,500) for Class III. These are one-time fees - registrations are valid for 5 years. A Mexico Registration Holder (MRH) is required for foreign manufacturers and typically costs $2,000-$5,000/year additionally.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
New Registration - Class I | MXN 15,896 | One-time per product |
New Registration - Class II | MXN 23,314 | One-time per product |
New Registration - Class III | MXN 29,673 | One-time per product |
Registration Renewal Fee amount to be determined | TBD | Every 5 years |
Key Facts About COFEPRIS Fees
- 1Class I: MXN 15,896 (~$800)
- 2Class II: MXN 23,314 (~$1,200)
- 3Class III: MXN 29,673 (~$1,500)
- 4Registration valid 5 years
- 5MRH required (not included in fees)
Important Notes
- •One-time registration fees per product
- •Renewal required every 5 years (fee TBD)
- •Fees vary by device class
Tips for Mexico Registration
- 1Choose your MRH carefully - they hold your registration
- 2Plan for 5-year renewal timeline
- 3Prior FDA/CE can expedite review
Frequently Asked Questions
Government fees are subject to change. Last data update: 2025-09-17. Always verify current fees with COFEPRIS.