The Mexican Chamber of Deputies recently reviewed and passed the amendment to the 2027 Federal Rights Law (Ley Federal de Derechos). According to related reports, the amendment covers 29 service fees of the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), with medical device registration official fees expected to increase by 71% to 106%. Important note: the amendment must still complete the remaining legislative procedures. The amounts below are proposed figures, not the official fee schedule already in effect for 2027.
Original Article
Modificaciones a la Ley Federal de Derechos – Paquete Economico 2027 (PDEA)
1. Proposed Adjustments to Initial Registration Official Fees
Based on COFEPRIS 2026 fee standards and related reports on the 2027 amendment, the initial registration fees for medical devices are proposed to be adjusted as follows (in Mexican pesos):
| Medical Device Class | Current 2026 Official Fee | Proposed Increase | Estimated 2027 Official Fee |
|---|---|---|---|
| Class I | 16,498.70 | approx. 71.7% | approx. 28,328.27 |
| Class II | 24,198.08 | approx. 74.5% | approx. 42,225.65 |
| Class III | 30,797.57 | approx. 106.2% | 63,516.60 |
Registration amendment and renewal fees may also rise accordingly. Under Article 195-A of the current Federal Rights Law, other registration amendments and renewal fees are charged at 75% of the corresponding registration fee, while changes to the registration holder’s name and other holder-related changes are charged at 50%. Once the base registration fee increases, these proportionally calculated fees will rise in step.
2. Proposed Effective Date
This adjustment is part of the amendment to the 2027 Federal Rights Law and is expected to take effect on January 1, 2027. However, as of now the amendment is still in the remaining legislative procedures, and the proposed amounts above cannot yet be regarded as officially effective fee standards. Companies should continue to monitor the Senate’s review results and the final published text of the law.
3. Three Recommendations for Companies
- If the proposed standards are ultimately approved, initial registration official fees will increase, and renewal fees as well as certain registration amendment fees will also rise. For companies with a large number of products that need to continuously maintain multiple registration certificates, overall registration and maintenance costs may increase further.
- For companies planning to process registration renewals, holder changes, or other registration amendments in 2027, it is recommended to review the validity periods of the relevant certificates and the expected filings in advance, assess budgets against the finally effective fee standards, and arrange processing schedules appropriately.
- When preparing the 2027 budget for market access in Mexico, companies should not consider only initial registration fees; subsequent renewal and registration amendment official fees should also be included in the assessment to avoid underestimating the full life-cycle compliance costs.
The amounts in this article are taken from reports on the amendment and represent proposed figures; the final amounts are subject to the legal text officially published by Mexico and COFEPRIS fee notices.