The question comes up more often than you’d think. A device company has a COFEPRIS registration filed or already granted in Mexico, and then the commercial picture changes: a new distributor, an added importer, a distributor that has to come off the file. The next email to the regulatory team is always some version of “Does this delay us, and what do we have to file?”
I’m Julio Martinez-Clark, CEO of bioaccess®. We help medical device companies through first-in-human studies and market access across the Americas, and Mexico is one of our core countries. This article explains how COFEPRIS handles distributor and importer changes on a device registration (registro sanitario) after the 2025 and 2026 simplification agreements, and how I’d handle a change that comes up while an application is still under review.
The short answer
Once a registration is granted, a change to the authorized distributor in Mexico is filed as an administrative modification under homoclave COFEPRIS-2022-022-003. Since the simplification agreement published in the Diario Oficial de la Federación (DOF) on 11 July 2025, “change or inclusion of the authorized distributor in national territory” is on the closed list of resolución inmediata cases (Modality A). COFEPRIS checks the fee payment and issues a constancia without a technical review, as long as the file meets the requirements. Changes outside that list, such as a change in the company name of the holder, distributor, importer or manufacturer, go through Modality B (dictaminación), which involves an evaluation. A transfer of the registration itself (cesión de derechos) is now handled inside Modality B, not as a separate procedure.
The modification procedures change the conditions of an existing registration. If your application hasn’t been granted yet, there’s nothing to modify. That’s where most of the timing questions come from.
What changed in 2025 and 2026
Before 2022, device modifications were filed under COFEPRIS-04-002, Modalities A to H. In 2022 they were regrouped into separate homoclaves for administrative changes (COFEPRIS-2022-022-003-A), technical changes (COFEPRIS-2022-022-004-A) and transfers (COFEPRIS-2022-022-005-A).
The DOF agreement of 11 July 2025 merged the administrative and transfer procedures into one: “Modificación administrativa del registro sanitario de dispositivos médicos,” homoclave COFEPRIS-2022-022-003, with two modalities:
- Modality A, immediate resolution. The agreement says COFEPRIS “will only validate the payment of the respective fee and issue the document,” provided the requirements are met.
- Modality B, dictaminación. COFEPRIS may run an evaluation before issuing a resolution.
Article three of that agreement lists the Modality A cases. The ones relevant to distribution are:
- Change of address of the holder and/or the national distributor
- Change or inclusion of the authorized distributor in national territory
- Change of company name of the foreign distributor
- Change of address of the foreign distributor
- Inclusion of new foreign distributors
- Removal of manufacturers (as long as at least one remains), presentations, distributors and similar items
- All administrative and technical modifications of low-risk device registrations, except a transfer of rights
The list is closed. Anything not expressly listed goes to Modality B.
What goes into a distributor change file
For Modality A, the 2025 agreement requires:
- The modification form FF-COFEPRIS-15, fully completed
- Proof of payment of the fee under the Ley Federal de Derechos
- Technical, scientific and legal information that justifies the modification, following COFEPRIS’s criteria for supporting documentation on device modifications
- If the change affects the label, a label project in Spanish that meets the applicable NOM (labeling of medical devices is governed by NOM-137-SSA1)
In practice, the document that justifies a new importer or distributor is a letter of representation from the manufacturer that names the new party. COFEPRIS’s modification guidance asks for a letter authenticated by the legal procedure of the country of origin, with a Spanish translation by a perito traductor if it’s in a language other than Spanish or English. COFEPRIS has accepted English documents for some years, but your Mexican partner should confirm the current requirement for each document before you send anything abroad for authentication. Our guide to COFEPRIS language requirements covers this in detail.
Also remember the label. Mexican labeling names the importer or distributor, so a distributor change usually means a new label project too. That’s the part teams forget, and it’s the part that causes the most rework.
Timing: what you can plan on
- Modality A is immediate resolution in principle. While COFEPRIS’s digital platforms were being adapted, the 2025 agreement’s first transitional article allowed in-person filing with a maximum of 10 business days. Treat the 10 days as the planning number until your partner confirms the digital route is working for your filing.
- Modality B was 22 business days. The 2025 agreement cut transfers to 15 business days. A DOF agreement of 4 May 2026 cut Modality B generally to 15 business days, but its fifth transitional article says the reduction takes effect only once the supporting platforms are running. Don’t build a launch date on 15 days without checking.
- Technical modifications (COFEPRIS-2022-022-004-A) remain at 22 business days per the official procedure listing.
One rule matters more than the timelines. If COFEPRIS issues a prevención (a request for missing information) and you don’t answer within the deadline it sets, which can’t be shorter than five business days, the filing is discarded. You start over with a new fee and a new clock.
When the change comes up during review
This is the scenario sponsors ask me about most. You filed the registration naming one distributor or importer, and before the grant you need a different one.
The modification procedures apply to an existing registration, so you can’t file a distributor modification against an application. The realistic options are:
- Let the application run and modify after the grant. If the new distributor can be covered by Modality A, this is usually the fastest route overall. You keep your place in the review queue, and the change is a short filing afterward. The cost is a period where the registration names a party you’re moving away from, so your commercial agreements need to allow for that.
- Withdraw and refile. This resets the review clock. I’d only consider it when the party named in the application can’t stay on the file, for example because the relationship has ended badly and that party won’t cooperate.
- Ask your Mexican partner to raise it with COFEPRIS directly. Whether a change can be absorbed into an open file, for example in the response to a prevención, depends on the file. That’s a question for COFEPRIS through your holder, not something to assume.
Whichever route you choose, settle the question of who holds the registration before you file. In Mexico the holder needs a Mexican domicile, and many companies name their distributor as holder. That’s the arrangement that creates distributor lock-in. If the holder is independent of the distributor, changing distributors later is a Modality A filing. If the distributor is the holder, you’re looking at a transfer of rights in Modality B, which needs the holder’s cooperation and a notarized transfer agreement, and must be notified to COFEPRIS within 30 business days under article 202 of the Ley General de Salud. See our pieces on registration holder vs. distributor and transferring a registration to a new holder.
Mistakes I see
- Filing by dictaminación something that qualifies for immediate resolution, especially for low-risk devices, where even technical changes go through Modality A.
- Forgetting that the label names the distributor, and filing without an updated Spanish label project.
- Starting the manufacturer’s letter authentication late. Authentication and translation often take longer than the COFEPRIS step.
- Planning on the conditional 15-day Modality B timeline.
- Missing the deadline to answer a prevención, which discards the filing.
- Naming a distributor as holder without thinking about the exit.
Frequently asked questions
Does adding a second distributor in Mexico need a COFEPRIS filing? Yes. Inclusion of an authorized distributor in national territory is an administrative modification. Since July 2025 it has been on the immediate-resolution list (Modality A).
Is a change of importer the same as a transfer of the registration? No. Changing or adding a distributor or importer leaves the holder in place. A transfer (cesión de derechos) changes the holder, is handled in Modality B and needs a notarized agreement.
Does a distributor change reopen the technical review? Not in Modality A, where COFEPRIS validates the fee and issues a constancia. COFEPRIS can still verify the constancia later and can revoke it if any information is false.
Can I change the distributor named in a pending application? There’s no modification procedure for an application that hasn’t been granted. Most companies wait for the grant and then file the change. Ask your holder to confirm with COFEPRIS if the change can’t wait.
If you’re planning Mexico market access, or want a holder structure that doesn’t tie you to one distributor, bioaccess® can help. See our Mexico COFEPRIS page and the Latin America market access overview.
Sources: DOF, Acuerdo de simplificación de trámites COFEPRIS, 11 July 2025 (arts. 1–3, 7, 12; first transitional article); DOF, Acuerdo de simplificación, 4 May 2026 (fifth transitional article); DOF, Acuerdo de simplificación, 22 August 2025; COFEPRIS guide to modifications of device registration conditions; Ley General de Salud art. 202; Reglamento de Insumos para la Salud arts. 153 and 190 Bis 5; NOM-137-SSA1.