Modificacion Amendment Fees in Mexico: the 75 and 50 Percent Tiers

1. Key takeaways

When a registered device undergoes changes to its design, manufacturing process, raw material manufacturer or legal ownership, the change must be submitted for approval through the amendment (Modificación) procedure; adjusting the device first and continuing to sell is not permitted. Fees fall into two tiers: other registration amendments are charged at 75% of the corresponding registration fee, while a change of registration holder name and other holder-related changes are charged at 50%. The two-tier structure rewards planning, because the tier that applies is determined by the type of change, not by the applicant’s preference. A portfolio that anticipates which changes will be needed — and when — can forecast its amendment costs precisely, while one that discovers changes late pays the same fees on a compressed timeline with sales interrupted in between. The difference between those two positions is set years earlier, in how the change control process treats the registration file.

• Changes to design, manufacturing process, raw material manufacturers or legal ownership must go through the amendment procedure before the device is marketed in its new state.
• Other registration amendments are charged at 75%; holder name changes and other holder-related changes at 50% (Article 195-A of the Federal Rights Law).
• Under LGS Article 376, unauthorised changes to the device and unapproved changes of raw material manufacturer are grounds for cancellation of the registration.
• Under NOM-137-SSA1-2025, label information must match the registration documents exactly, and newly required label information can trigger an amendment.
• Relabelling (contraetiquetado) in Mexico under Chapter 18 of NOM-241-SSA1-2025 allows Spanish information to be added after customs clearance and before commercialisation.

2. Legal basis

Four sources frame the amendment regime: the General Health Law provision that links changes to cancellation, the fee article that sets the two charging tiers, the labelling standard that can generate amendments in batches, and the regulation article governing official forms. Their combined effect is summarised below.

3. Expert insights

Insight one: LGS Article 376 links amendments directly to cancellation. Among the cancellation grounds listed in the amended Article 376 are failure to apply for renewal within the prescribed period, making unauthorised changes to the device, and changing the raw material manufacturer without prior approval. Amendments are therefore not optional. The regime treats a device that no longer matches its registration as a device whose authorisation has lapsed in substance, which is why proceeding without approval exposes the entire registration rather than just the changed element. The message for engineering teams is unambiguous: the change control gate and the regulatory gate are the same gate.

Insight two: the two fee tiers correspond to two types of change. Other changes related to the technical content of the product are charged at 75%; changes concerning the holder itself, such as a name change, are charged at 50%. Project budgets must account for the two separately. Blending them produces forecasts that are wrong in both directions, overpricing holder work and underpricing technical amendments that recur across a device lifecycle.

Insight three: a label revision can trigger amendments in batches. NOM-137-SSA1-2025 requires all information on the commercial label to match the health registration documents issued by COFEPRIS exactly. Where the new standard adds elements such as intended use, manufacturing date, catalogue number, model or version, adding or changing those items on the label may require an application to amend the registration conditions. Because the change affects the whole portfolio at once, label migration is best handled as a programme rather than as isolated filings.

Insight four: Chapter 18 of NOM-241-SSA1-2025 governs relabelling. For imported products whose labels cannot be changed at origin, Spanish information can be added in Mexico through relabelling (contraetiquetado). The relabelling must be completed after customs clearance and before commercialisation. This route preserves market flow for stock printed under the old label, but only if the relabelling step is operationally planned and executed inside that window. Teams should treat the relabelling site, the process and the timing as part of the label transition plan rather than as an afterthought at the border.

Insight five: amendments carry lag costs. The amendment application itself takes time and fees, and during that period the product cannot be sold in its new state. Building amendments into the product iteration plan is cheaper than remediating afterwards. The cheapest amendment is the one scheduled alongside the engineering change that caused it, with marketing timelines adjusted to the approval rather than assumed ahead of it.

4. Practical recommendations

• Maintain a change trigger list covering six categories — design, process, materials, suppliers, labelling and holder information — and start an assessment whenever any of them moves.
• Budget amendments under the 75% and 50% tiers separately and do not mix the two in any cost model.
• Schedule the NOM-137-SSA1-2025 label transition as a portfolio of amendment items, back-planned from the effective date (360 calendar days after publication).
• Plan the capability for relabelling within Mexico in advance for imported products, so that label stock printed abroad does not block commercialisation.
• Do not release the product in its new state before the amendment has been approved.

5. Verification checklist

• □ The change trigger list covers all six categories
• □ Fees are accounted under the 75% / 50% tiers
• □ The label transition is scheduled as amendment items
• □ Relabelling capability has been planned
• □ The product is not released in its new state before approval

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