Registro Sanitario Fees 2026: COFEPRIS Registration Costs by Risk Class

1. Key takeaways

The official fees for Mexican medical device health registrations are charged under Article 195-A of the Federal Rights Law. For 2026 the three class amounts are: Class I 16,498.70 Mexican pesos, Class II 24,198.08 Mexican pesos, and Class III 30,797.57 Mexican pesos. Renewals and other registration amendments are charged at 75% of the corresponding registration fee; a change of registration holder name and other holder-related changes are charged at 50%. These percentages are not interchangeable, and they compound across the device lifecycle: every renewal and every amendment multiplies the class fee set at first registration, so a classification decision made once echoes through every later payment in the product’s history. A fee review at the start of the project is therefore a classification exercise as much as an arithmetic one.

• 2026 first-registration fees: Class I 16,498.70 pesos, Class II 24,198.08 pesos, Class III 30,797.57 pesos.
• Renewals and other registration amendments are charged at 75% of the corresponding registration fee.
• A change of holder name and other holder-related changes are charged at 50%.
• Import-permit-related fees fall under Article 195-G, with itemised amounts governed by the publication for the year in question.
• The proposed 2027 increases remain in the legislative process and are not in force; they should not be written into quotations or contracts.

2. Legal basis

Four provisions together determine what a registration costs in Mexico: the fee article that prices first registrations by risk class, the charging rules that set the percentage tiers for renewals and amendments, the article covering import-permit fees, and the regulation articles that make the risk class drive the fee tier. Each is set out below.

3. Expert insights

2026 first-registration official fees (in Mexican pesos)

Insight one: official fees are adjusted annually. The Federal Rights Law is updated each year with the fiscal package, and the amounts in force are those published for the year. Multi-year projects should be costed against the fee schedule of the year of submission, not against the previous year’s figures. Carrying stale numbers into a budget is a small error at filing stage but a compounding one across a portfolio of registrations.

Insight two: renewals and amendments are charged proportionally, at two tiers. Renewals and other registration amendments are charged at 75% of the corresponding registration fee; a change of registration holder name and other holder-related changes are charged at 50%. The two tiers are different and must not be mixed in budgeting. Keeping the categories separate in the cost model makes it possible to price holder-related workstreams accurately, which matters when transfers or corporate reorganisations are on the table.

Insight three: a classification error propagates across the whole fee lifecycle. The class determines the tier for first registration and also the base for every subsequent renewal and amendment. The financial impact of a classification judgement is therefore long-lived. Getting the class right at the outset is one of the cheapest cost controls available in the entire Mexican process, since correcting it later means paying again on a different base.

Insight four: the 2027 increase is still in the legislative process. Media reporting indicates that the draft 2027 revision of the Federal Rights Law proposes increases of approximately 71% / 74% / 106% for the three registration classes, but as of the verification date the subsequent legislative steps remain outstanding. This is not a standard in force and should not be written into quotations or contracts. Treating it as a range for sensitivity analysis, rather than a committed number, keeps commercial documents honest.

Insight five: official fees are only part of the total cost. The larger cost items are usually dossier preparation, translation and notarisation or legalisation, the certificate of free sale, the holder arrangement, and the registration submission service itself; import permits carry separate fees. Budgets that track only the official fee therefore systematically understate the real cost of market entry, and the non-official items should be itemised explicitly so that management sees the full cost of entering and staying in the market.

4. Practical recommendations

• Structure the budget under four separate lines — first registration, renewal (75%), amendments (75% or 50%) and import permits — so that each cost driver is visible and none is buried inside a blended figure.
• Re-check the fee schedule once each year after the fiscal package is published, and cost multi-year projects at the amounts for the year of submission.
• Finalise the classification conclusion before costing, so the project does not have to be recalculated midway through a change of class.
• Treat the 2027 increases as proposed: carry a floating range in the budget rather than locking in a figure that is not yet law.
• List translation, notarisation and holder-service costs separately and do not fold them into the official-fee estimate.

5. Verification checklist

• □ The three class amounts have been costed on the 2026 fee schedule
• □ Renewals and amendments are budgeted separately at the 75% / 50% tiers
• □ The classification conclusion has been finalised
• □ The 2027 increases are treated as proposed and not in force
• □ Translation, notarisation and holder-service costs are listed separately
• □ Import permit fees are included as a separate line

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Mexican market. Our team manages COFEPRIS registrations and equivalence (equivalencia) reviews, coordinates third-party authorised centre routes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com