COFEPRIS language requirements: what must be in Spanish in a Mexico medical device submission, and what NOM-137-SSA1-2025 changes

A manufacturer sends me a clean, well-organized registration file for Mexico. The technical documentation is complete, the FDA clearance is in place and the test reports are signed. Almost all of it is in English. The first question I ask isn’t about the device. It’s this: which of these documents has to be in Spanish, who signs the translations, and which ones need a certified translator and an apostille? In Mexico, language isn’t a formatting detail you sort out at the end. It’s written into the regulation, and it’s one of the most common reasons a COFEPRIS file comes back with a request for information.

I am Julio Martinez-Clark, CEO of bioaccess®. We act as registration holder and in-country partner for medical device manufacturers in Latin America, and we run first-in-human and early feasibility studies across the Americas. This page covers what the Mexican rules actually say about language, what changes when the new device labeling standard, NOM-137-SSA1-2025, comes into force, where sponsors get caught, and the checklist I use before a Mexican dossier goes in.

One-sentence answer

For a medical device registration (registro sanitario) in Mexico, every document attached to the application must be in Spanish or come with a Spanish translation signed by the Mexican responsible health officer (responsable sanitario); documents issued by foreign authorities, such as a certificate of free sale, must also be apostilled or legalized and translated by a certified translator (perito traductor); and the label project and the instructions for use or operating manual must be submitted in Spanish, with the brand name being the only label element allowed in another language.

What the rules actually say

Article 153: every attachment in Spanish, or translated

The general rule sits in Article 153 of the Reglamento de Insumos para la Salud (RIS), the regulation that governs the registration of medicines and medical devices in Mexico. COFEPRIS repeats it word for word in its registration trámite guide published in the Diario Oficial de la Federación and again in the January 2020 equivalence agreement. It has three parts:

• Documents that accompany an application must be written in Spanish.
• If they aren’t, the applicant attaches a Spanish translation, endorsed with the signature of the responsable sanitario, the licensed professional who answers to COFEPRIS for the establishment.
• Documents issued by authorities of other countries must be apostilled or legalized and translated by a perito traductor, a court-certified translator.

That last line is the one that trips people up. A test report or a design description can be translated in-house and endorsed by the responsable sanitario. A certificate of free sale, a government-issued GMP certificate or an FDA Certificate to Foreign Government can’t. Those need the apostille or legalization and a certified translation.

Article 179: label and IFU in Spanish

Article 179 of the RIS lists what a device registration application must include. Two of the items specify the language directly: the label project in Spanish, under the applicable Mexican standard (fraction II), and the instructions for use, where they apply, or the operating manual in Spanish (fraction III). COFEPRIS’s trámite guide carries the same two items into each registration modality, including the equivalence routes for devices already approved by the FDA, and into technical modifications of an existing registration.

Article 180: the foreign documents

For devices made outside Mexico, Article 180 adds the documents that most often need the apostille and certified translation: the certificate of free sale or equivalent from the country of origin, the manufacturer’s letter of representation when the product isn’t made by the company applying, the GMP certificate from the health authority of the country of origin, and the manufacturer’s certificate of analysis. The trámite guide says the letter of representation must be authenticated under the procedure of the country of origin and, if it isn’t in Spanish, translated by a perito traductor.

NOM-137: what the label must say, and in which language

The current device labeling standard is NOM-137-SSA1-2008. Its section 4.1 requires label and counter-label information to be in Spanish, in clear and legible terms, without preventing other languages from appearing too. Text in another language can be the same size as the Spanish but can’t contradict it. If the original label doesn’t comply, a Spanish counter-label (contraetiqueta) can carry the missing health information, as long as it doesn’t cover information that affects the product’s quality or use. Section 4.1.1.2 says the distinctive name (the brand) is the only required element that can appear in a language other than Spanish.

What changes with NOM-137-SSA1-2025

COFEPRIS published the replacement standard, NOM-137-SSA1-2025, Etiquetado de dispositivos médicos, in the Diario Oficial on 19 May 2026. Under its chapter 11, it enters into force 360 calendar days after publication, which Mexico’s standards registry lists as 14 May 2027. At that point it replaces the 2008 standard. Its second transitional article gives devices whose labeling can’t be changed another 180 calendar days to use up existing packaging and finished product.

On language, the core rule doesn’t move. Section 5.1 still requires label information to be in Spanish, in understandable terms with legible type and size, and still allows other languages. Section 5.7 keeps the rule that a second language can’t contradict the Spanish. Section 5.10.2 keeps the brand name as the only element allowed in another language. What’s new matters for international manufacturers:

• Electronic complements. Sections 5.2 and 5.10.11.1 allow label information and instructions for use to be complemented electronically, through RFID, barcodes, QR codes or a website, provided the electronic content doesn’t replace or contradict what COFEPRIS authorized. In other words, a QR code can point to more information. It doesn’t remove the need for Spanish on the physical labeling.
• Counter-labels after customs. Section 5.7.1.1 says that for imported devices, the counter-label can be applied in Mexico after customs clearance, before the product is sold or supplied. That’s a practical gain for manufacturers who don’t want a Mexico-specific label on the production line.
• Shared responsibility for the IFU. Section 5.6 makes the health information in manuals and instructions for use the responsibility of both the manufacturer and the registration holder (titular del registro sanitario). If you use a third-party holder, they are now explicitly on the hook for your Spanish IFU.
• Labeling under document control. Section 5.8.2 requires the holder or manufacturer to keep labeling under document control, with version control. A translated IFU that drifts from the English master is now a compliance gap, not just a quality problem.
• Software. Section 6.3.2 allows software without a physical form or packaging to carry its labeling electronically, accessible through the software itself or a website.
• Symbols. Section 5.9 and Appendix A set the symbols that can be used. Symbols outside the appendix or international references need a description in the labeling, and that description has to be in Spanish too.

If you register in Mexico in 2027 or later, I’d write the Spanish label and IFU to the 2025 standard now. The label you submit with the registration has to match the authorization (section 5.5), and changing it later means a modification request.

What about clinical trials?

For a first-in-human or early feasibility study in Mexico, the language question shows up in the informed consent first. Mexico’s Reglamento de la Ley General de Salud en Materia de Investigación para la Salud requires, in Article 21, that the participant receive a clear and complete explanation in a way they can understand, and in Article 22, that the consent be in writing, reviewed by the institution’s ethics committee and signed by the participant and two witnesses. For Mexican participants, that means a Spanish consent form written in plain language, not a literal translation of a sponsor template. Our knowledge base guide to informed consent for first-in-human studies in Mexico goes through it in detail.

I also plan Spanish for anything site staff will use at the bedside: the investigational device’s instructions, the training material and patient-facing documents. The COFEPRIS submission package guide for first-in-human device trials covers the rest of the study file, and the COFEPRIS pathway for first-in-human trials covers the approval sequence.

A note for drug and biologic sponsors: the rule isn’t identical across product types. COFEPRIS’s January 2020 equivalence agreement for medicines already approved by reference regulators, including the FDA and Health Canada, keeps the Article 153 rule but lists technical and scientific documents it accepts in English. For example, it accepts full CTD reports in Modules 3 to 5 in English with Spanish summaries. Read the instrument that applies to your product. Don’t assume the device rule carries over, or the other way round.

Where sponsors get caught

1. Translating the certificate but not apostilling it. A certified translation of a document that was never apostilled or legalized doesn’t meet Article 153. Order the apostille in the country of origin first, then translate the apostilled document, so the translation covers the apostille too.
2. Machine-translated IFUs with no owner. Article 153 requires the responsable sanitario to sign the translation, and NOM-137-SSA1-2025 makes the holder co-responsible for the IFU. Someone in Mexico has to read the translation and stand behind it.
3. Labels that don’t match the authorization. The Spanish label project in the file becomes the label COFEPRIS authorizes. Marketing changes after approval, such as a new claim or a new model list, mean a modification request.
4. Relying on a QR code. Under the new standard, an electronic link can complement the label and IFU. It can’t replace the Spanish health information on the labeling.
5. Assuming an FDA route removes the language work. The equivalence modalities for FDA-approved devices shorten the technical review. They don’t remove the Spanish label project, the Spanish IFU or the apostille on the FDA documents. Our post on regulatory reliance in Latin America and the knowledge base page on the COFEPRIS equivalence agreement explain what reliance does and doesn’t buy you.
6. Version drift. The English IFU gets a new revision for the US and nobody updates the Spanish one. NOM-137-SSA1-2025 now expects the holder or manufacturer to control labeling versions.

My checklist before a Mexican device dossier goes in

• A document list split into three columns: already in Spanish; translate and have the responsable sanitario sign; apostille or legalize, then certified translation.
• Apostilles ordered early for the certificate of free sale, the GMP certificate and any FDA-issued document, plus authentication of the letter of representation.
• A Spanish label project written to the current NOM-137 and checked against NOM-137-SSA1-2025 if launch will fall after 14 May 2027.
• A Spanish IFU or operating manual, reviewed by a clinician who uses the device type, with a version number tied to the English master.
• A decision on counter-labels: printed in Mexico after customs, or applied at the factory.
• For any electronic IFU or QR link, confirmation that the content matches what COFEPRIS authorizes and that the Spanish health information stays on the physical labeling.
• A named registration holder in Mexico who understands they share responsibility for the IFU. Our posts on holder vs distributor and transferring a registration to a new holder cover that choice.

Frequently asked questions

Can I submit my technical file to COFEPRIS in English?

Not as-is. Under Article 153 of the RIS, any attachment that isn’t in Spanish needs a Spanish translation signed by the responsable sanitario, and documents issued by foreign authorities need an apostille or legalization and a certified translation.

Does the device label have to be fully in Spanish?

The required health information does. Other languages can appear alongside it, at up to the same size, as long as they don’t contradict the Spanish. The brand name is the only required element that can be in another language.

Can a QR code or website replace the printed Spanish IFU?

Under NOM-137-SSA1-2025, electronic means can complement the instructions for use but can’t replace or contradict what COFEPRIS authorized. For software without a physical form, labeling can be provided electronically.

When does NOM-137-SSA1-2025 apply?

It was published on 19 May 2026 and enters into force 360 calendar days later (14 May 2027, per Mexico’s standards registry), replacing NOM-137-SSA1-2008. Devices whose labeling can’t be changed get another 180 calendar days to use up existing stock.

How bioaccess® helps

We build the Mexican dossier with the language plan in it from day one: which documents get translated and signed, which get apostilled and certified, and a Spanish label and IFU written to the standard that will apply on your launch date. As registration holder, we sign for what we file. See our medical device registration in Mexico (COFEPRIS) service or the full Latin America market access overview, and our post on ordinary vs equivalence registration routes in Mexico.