Registration Transfer and Titular Change for Medical Devices in Mexico

1. Key takeaways

A Mexican health registration names the holder (titular), and changing the holder requires a formal COFEPRIS procedure; it does not take effect merely because the parties sign an agreement between themselves. The friction points in a transfer concentrate in three places: whether the outgoing holder cooperates, whether the incoming holder is qualified (holding an operating notice and platform access), and whether the product can continue to be sold legally while the transfer is in progress. Each of these is a planning question as much as a legal one. Manufacturers who assume the transfer will be quick, or who discover late that the new entity lacks one of the qualifying elements, tend to lose selling time precisely when commercial relationships are already strained.

• The registration belongs to whoever is named as the titular; only COFEPRIS can confirm a change of holder.
• A change of holder name is charged at 50% of the corresponding registration fee under Article 195-A of the Federal Rights Law, a different tier from the 75% that applies to other amendments.
• The incoming holder must already have Mexican legal personality, an operating notice, a valid e.firma / FIEL and a DIGIPRiS account.
• While the transfer is pending, import permits can only be applied for by the holder of record or a licensed distributor listed on the registration.
• Structuring the holder as an entity independent of the commercial channel reduces the likelihood of transfers being needed at all.

2. Legal basis

Three sources govern the transfer of a Mexican health registration: the regulation that defines who can qualify as a holder, the Federal Rights Law that sets the fee tier for holder-related changes, and the COFEPRIS platform on which the transfer itself is declared. The table below sets out each source and what it contributes.

3. Expert insights

Insight one: whoever the registration names is the holder in law. The health registration is issued in the name of the titular, and any transfer must be confirmed by COFEPRIS. A commercial contract clause stating that the registration belongs to the manufacturer cannot, in Mexico, be asserted directly against the registration record. Contractual rights and regulatory reality run on separate tracks, and only the regulatory track determines who may apply for permits, respond to the authority, and keep the product on the market. This is why the agreement matters for leverage and cost recovery, but never as a substitute for completing the procedure itself.

Insight two: the transfer has a defined fee tier. Article 195-A of the Federal Rights Law charges a change of registration holder name, and other changes related to the holder, at 50% of the corresponding registration fee, which is a different tier from the 75% that applies to other amendments. Budgeting a transfer with the wrong tier creates avoidable mismatches between the project forecast and the actual payment, so the two categories should be kept apart from the earliest cost estimate onward.

Insight three: the incoming holder’s qualifications must be in place first. The new entity needs Mexican legal personality, an operating notice, and a valid e.firma / FIEL together with a DIGIPRiS account. If any element is missing, the transfer application stalls at the intake stage. Since the FIEL depends on tax registration and the operating notice depends on facility documentation, these prerequisites have their own lead times and should be treated as a preparatory workstream running before the transfer is filed.

Insight four: sales continuity during the transfer must be designed in advance. Until the transfer is complete, import permits can only be applied for by the holder named on the registration or by licensed distributors listed on it. Scheduling should therefore avoid supply interruptions: either the timing of shipments is planned around the transfer window, or the existing listed distributors carry inventory through the gap. Deciding this after filing starts is usually too late, because the permit window and the transfer window rarely align by accident.

Insight five: the fundamental way to reduce difficulty is structural design. Setting the holder up as a compliance entity independent of the commercial channel reduces, at the source, the circumstances in which a commercial dispute triggers the need for a transfer. The best transfer is the one that never has to happen, and structure is the instrument that makes that outcome more likely.

4. Practical recommendations

• Write the cooperation obligation for transfers, its trigger conditions and its timelines into the cooperation agreement, and agree the consequences of breach, so that a reluctant outgoing holder faces defined commercial exposure rather than an open-ended negotiation.
• Assemble the incoming entity’s qualifications — legal personality, operating notice, FIEL and platform account — in full before starting the transfer, so the application does not stall at intake.
• Budget the holder name change at the 50% tier and account for it separately from other amendments charged at 75%.
• Link the transfer schedule to the import permit schedule and reserve inventory to avoid supply interruptions while the change of holder is pending.
• Prefer an independent third-party holder structure from the outset, reducing the probability that a transfer scenario arises at all.

5. Verification checklist

• □ The cooperation agreement contains transfer cooperation obligations and timelines
• □ The new entity’s legal personality, operating notice, FIEL and platform account are all in place
• □ Fees are budgeted at the 50% tier
• □ The transfer and import permit schedules are linked and inventory has been reserved
• □ An independent third-party holder structure has been evaluated

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