Entering the Mexican medical device market requires planning regulatory approvals and associated costs. A key aspect is understanding the fees charged by COFEPRIS and how the Marketing Authorization Holder (MHA) must cover them. This article breaks down those topics and outline important considerations for 2024.
Legal Basis for Fees:
COFEPRIS fees are established in the Federal Law of Fees and updated annually. The 2024 fees for medical device registrations (rounded) are as follows:
| Type of submission | Class I (MXN) | Class II (MXN) | Class III (MXN) |
| New Registration | 15,206 | 22,302 | 28,384 |
| Renewal/Technical Amendment | 11,404 | 16,726 | 21,288 |
| Administrative Amendment | 7,603 | 11,151 | 14,192 |
For convenience, COFEPRIS publishes an annual document summarizing these fees.
Payment Process:
- Payment in Advance: All fees must be paid before submitting any request.
- Authorized Mexican Bank: Use any authorized Mexican bank.
- Required Information on Receipt:
- MHA Company name and tax ID (RFC)
- Exact fee amount
- COFEPRIS codes: 55 (general), 100107 (registrations)
- Chain of procedure code (specific to request type)
Simplified Payments with e5cinco System:
The Mexican government’s e5cinco system simplifies fee payments:
- Access e5cinco: Visit https://tramiteselectronicos04.cofepris.gob.mx/e5cinco/
- Generate Payment Aid Sheet: Select payment type to receive a document with all the necessary information.
- Make Payment: Use online or physical banking.
- Submit Receipt to COFEPRIS: Include the payment receipt issued by your bank.
Key Points to Consider:
- Accurate Data: Ensure all payment details match the Payment Aid Sheet precisely.
- Yearly Validity: Fees are valid only for the year they were paid. However, you can use it in the future by paying the difference between the actual fees.
- Unused Payments: If unused, request proof from COFEPRIS to claim a refund through SAT.
Conclusions
Understanding COFEPRIS fees is a crucial step in registering your medical device in Mexico. The payment process is sometimes complex and may lead to rejections or preventions. Contact us at contact@veraqueconsulting.com for expert guidance on medical device registration in Mexico.
