By Julio Martinez-Clark, CEO, bioaccess®
A U.S. device company with a Mexican registro sanitario moves production to a new contract manufacturer. Everyone assumes it’s paperwork. Then the file sits at COFEPRIS for months, the distributor wants to know whether it can keep importing, and someone asks whether the change of importer they also need has to wait in line behind it. Here is how I explain the change-of-manufacturer route to sponsors, and what we actually do when one stalls.
The short answer
A change of contract manufacturer (maquilador) or manufacturing site on a Mexican device registration is a technical modification, filed under homoclave COFEPRIS-2022-022-004-A, “Modificación técnica con dictaminación a las condiciones del registro sanitario de dispositivos médicos”. COFEPRIS evaluates it and issues an oficio de resolución. It is not on the immediate-resolution list, except for low-risk device registrations, where the July 2025 simplification agreement moved every administrative and technical modification (other than a transfer of rights) to immediate resolution.
Administrative changes such as a new importer or distributor go through a separate procedure (COFEPRIS-2022-022-003) and are resolved on their own clock. A pending technical modification does not have to block them, and you should not merge the two into one file and hope.
What goes in a change-of-manufacturer file
The requirements for this route come from the COFEPRIS simplification agreements published in the Diario Oficial de la Federación (DOF) on 24 January 2022 and 22 August 2025. In practice the file carries:
- Form FF-COFEPRIS-15 (modification to the conditions of the registration), fully completed.
- Proof of payment of the government fee. Under the August 2025 agreement it equals 75% of the registration fee for the device’s risk class.
- Technical, scientific and legal information that justifies the change, following COFEPRIS’s published criteria for supporting documentation on administrative and technical modifications.
- An updated Spanish label or counter-label project under NOM-137-SSA1.
- For a new manufacturing site, national or foreign, the 2022 agreement adds: a Good Manufacturing Practice certificate from the competent authority of the country of origin (or from COFEPRIS for Mexican manufacturing), an original certificate of analysis or finished-product quality report, and, for foreign manufacturing, a Certificate of Free Sale from the country of origin.
The 2022 agreement accepts a current ISO 13485 certificate or a CE certificate from an authorized body as equivalent to the GMP certificate for Class I, II and III products. Documents issued by foreign authorities must be apostilled or legalized, and anything not in Spanish or English needs an expert (perito) translation under Article 153 of the Reglamento de Insumos para la Salud.
The boundary rule that gets files thrown out
A modification is only a modification if the device stays the same device. A change that affects safety, efficacy, functionality or intended use needs a new registration, not a technical modification. If the new manufacturer also changes materials, the sterilization method or the design, decide that question before filing, not after the first deficiency notice.
The second trap is the prevención (deficiency notice). The official procedure sheet gives COFEPRIS 7 business days to issue one for administrative gaps and 14 for technical gaps. The applicant gets a deadline of no less than 5 business days. Miss it and the file is desechado: closed, not corrected. You refile, pay again and start the clock again. Whoever monitors the e-notifications has to know that.
How long it really takes
Published figures differ. One industry summary of the 2025 agreement lists 11 business days for COFEPRIS-2022-022-004-A, while an analysis of the official procedure sheet in the National Catalog of Procedures and Services gives 22 business days and notes that neither 2025 agreement changed it. Plan for neither number. On a change-of-manufacturer file we follow, COFEPRIS was still “evaluating” in late September and the file was still unresolved in mid-November. That is normal for a dictamen route right now, and I tell sponsors to build their supply plan around it.
What matters for the business is that the existing registration stays in force while the modification is pending. Product made at the site already on the registration can keep moving. Product from the new site should not be released into Mexico under that registration until the oficio is in hand.
Running administrative changes in parallel
Most manufacturer changes come with other changes. The importer turns out to be listed as distributor when it now only acts as a virtual warehouse, or a new distributor comes in. Those are administrative modifications. Since the July 2025 agreement, a change or addition of the authorized distributor in Mexico is on the closed list of immediate-resolution cases. COFEPRIS validates the fee and issues a constancia, not a new registration, provided the file meets the requirements. In the files we see, the documents asked for are an apostilled letter of representation for the new distributors and the establishment’s operating notice (aviso de funcionamiento).
Because a technical modification produces an oficio and an administrative one produces a constancia, the two run on independent clocks. If the registration is wrong today about who imports, fix that now rather than waiting for the manufacturer change to clear. A COFEPRIS inspection that finds the listed distributor doing something different from what the registration says is a needless observation. I covered the distributor route in more detail in Changing your distributor or importer on a COFEPRIS device registration.
What to do when the technical modification stalls
- Confirm there is no unanswered prevención. Before escalating anything, check that the file is genuinely waiting on COFEPRIS and not on you. A missed deficiency notice looks exactly like a stall until it’s too late.
- Get the status in writing. Ask your registration holder or consultant to request a formal status from COFEPRIS rather than relying on phone updates.
- Use the investment channel if you have one. Mexico City’s Secretaría de Desarrollo Económico (SEDECO) runs an investment-attraction agency that tracks investment projects, and medical devices are on the city’s list of priority sectors. Consultants are now filing written requests through SEDECO asking COFEPRIS for a formal answer on pending procedures. To be included, you supply a short description of the associated project in Mexico City (borough and address), the approximate investment amount and the estimated number of jobs. It is not a legal deadline and it does not guarantee a decision, but it puts the file in front of someone with a reason to ask.
- Keep the administrative fixes moving. Do not let a stalled dictamen freeze the importer, distributor or address changes that resolve immediately.
- Plan inventory around the oficio, not the filing date. If the old site is closing, build stock from it before the switch.
Frequently asked questions
Is a change of contract manufacturer administrative or technical in Mexico?
Technical. A change of maquilador or manufacturing site, national or foreign, is filed as COFEPRIS-2022-022-004-A and evaluated (dictaminación), unless the registration is for a low-risk device, in which case it qualifies for immediate resolution.
Can I change the importer while the manufacturer change is still pending?
Yes. A change or addition of the authorized distributor in Mexico is an administrative modification on the immediate-resolution list. It runs separately from the technical modification and yields a constancia.
Does ISO 13485 count as the GMP certificate?
For Class I, II and III devices, the January 2022 agreement accepts a current ISO 13485 certificate or a CE certificate from an authorized body as equivalent to the GMP certificate. Foreign-issued documents still need an apostille or legalization.
What happens if I miss a COFEPRIS deficiency notice?
The procedure is discarded (desechado). You file again, pay the fee again and the review period restarts.
Sources
- DOF, 24 January 2022: COFEPRIS agreement listing homoclave COFEPRIS-2022-022-004-A requirements, including GMP certificate, certificate of analysis and Certificate of Free Sale for a change of manufacturing site, and ISO 13485/CE equivalence.
- DOF, 11 July 2025: simplification agreement creating COFEPRIS-2022-022-003 (Modality A immediate resolution, Modality B dictaminación) and the closed list of immediate-resolution cases.
- DOF, 22 August 2025: simplification agreement setting technical-modification requirements (FF-COFEPRIS-15, fee at 75% of the registration fee, supporting information, NOM-137-SSA1 label).
- National Catalog of Procedures and Services, official sheet for COFEPRIS-2022-022-004-A (deficiency-notice and discard rules), as analyzed by AR México, August 2026.
- El Economista, 29 January 2026: Mexico City installs its Investment Promotion Committee; SEDECO investment agency tracking more than 300 projects; medical devices among priority sectors.
If you are planning a manufacturing transfer for a device already registered in Mexico, or you need the registration cleaned up before a new distributor starts importing, see our LATAM market access service. — bioaccess®