Spanish Labelling under NOM-137-SSA1-2025: Transition from the 2008 Edition

1. Key takeaways

NOM-137-SSA1-2025 was published in the Diario Oficial de la Federacion on 19 May 2026 and enters into force 360 calendar days after publication, around 14 May 2027, when it will repeal the 2008 edition that has been in operation for 17 years. For packaging materials and finished stock that cannot be relabelled immediately, an additional sell-off period of 180 calendar days applies, running to approximately November 2027. The core changes of the new edition are: Appendix A incorporates 70 standardised symbols; the electronic label is recognised for the first time, on a supplement-only basis; rules for software as a medical device are established for the first time; and labelling design must be supported by documented risk management. The transition window is long enough to plan properly, but short enough that artwork, translation and production planning must be started now rather than after entry into force.

• The 2025 edition enters into force around 14 May 2027, with a 180-calendar-day sell-off period for existing stock.
• Appendix A brings 70 standardised symbols into a normative annex.
• Mandatory content expands to include intended use, manufacturing date, catalogue number or model or version number, single-use indication and adverse event reporting guidance.
• The electronic label may supplement but never replace or contradict the approved labelling information.

2. Legal basis

Four sources frame the transition. NOM-137-SSA1-2025, published on 19 May 2026, enters into force 360 calendar days after publication, with an additional 180-calendar-day period for consuming existing stock, and is the current not-yet-in-force edition. NOM-137-SSA1-2008, published on 12 December 2008, is the current edition and will be repealed on the entry-into-force date of the 2025 edition. The authorising basis sits in Articles 194, 194 Bis, 195, 210, 212, 214 and 262 to 266 of the Ley General de Salud. The labelling and Spanish-language documentation requirements sit in Articles 11, 24, 165, 179, 182 and 183 of the Reglamento de Insumos para la Salud, as amended by the order published on 24 April 2026. The table below consolidates these sources.

3. Expert insights

Insight 1: seventeen years of elapsed time create structural differences. While the 2008 edition was in operation, the European MDR entered into application, the IMDRF advanced global harmonisation, UDI was implemented across multiple markets, and software as a medical device moved from concept to mainstream. These developments are concentrated in the 2025 edition. The new standard should therefore be read not as an incremental refresh of the old one but as a re-authoring that absorbs a generation of international practice, and comparison tables written against the 2008 text will miss changes that only appear at the level of structure and intent.

Insight 2: the mandatory content expands substantially. Beyond the established elements of product name, manufacturer information, registration number, expiry date and batch number, the new edition adds the intended use, the manufacturing date, which may be included within the batch number or serial number provided it is clearly distinguishable, the catalogue number, model or version number, which changes from optional to mandatory, the single-use indication, and adverse event reporting guidance. Of these, the intended use and the date and catalogue items are the ones most often overlooked, because legacy artwork frequently predates the requirement and the omissions are only visible when the label is checked element by element against the new list.

Insight 3: the 70 symbols are grouped by information category. Appendix A, which is normative, incorporates 70 standardised symbols together with safety information, unifying the expressions used for expiry date, storage conditions and warnings on critical materials, such as the presence of latex or hazardous substances, and classifying them according to the information they convey for ease of use in post-market surveillance. Building an internal symbol library against this annex, with each symbol mapped to its category and its trigger condition, turns the transition into a controlled engineering exercise rather than an artwork negotiation.

Insight 4: the electronic label carries two hard limits. Technologies such as QR codes, barcodes or RFID may be used to supplement, but they must not replace or contradict the labelling information approved in the registration. The registration number, batch number, expiry date and warnings must be presented physically and cannot be placed only inside a code. Both limits should be embedded in artwork review procedures as explicit checkpoints, because the second limit in particular is where creative packaging designs tend to drift towards a purely digital presentation of information that the standard requires in print.

Insight 5: the relabelling route for imported products is preserved. Imported products that do not fully comply with the standard at origin can still complete their Spanish-language information within Mexico through relabelling (contraetiquetado), which must be done after customs clearance and before commercialisation or supply to the public. The sequencing rule is strict, so importers should plan the relabelling capability, its site and its timing, into the supply chain rather than discovering at the border that the step cannot be performed in the window available.

Insight 6: the registration holder is pulled into the chain of responsibility. The 2025 edition adjusts the definitions of manufacturer and legal manufacturer, and the responsibilities of the legal manufacturer are elevated. The registration holder must share with the manufacturer the responsibility for defining the intended use stated on the labelling, and must participate in the development and review of the instructions for use. A holder that treats labelling as entirely the manufacturer’s affair no longer matches the allocation of duties in the standard, and the participation should be documented to be demonstrable.

4. Practical recommendations

• Plan backwards from the entry-into-force milestone of approximately 14 May 2027: label design, Spanish-language review, submission of registration amendments and production of new labels, with a buffer on each of the four stages.
• Build a symbol library and re-lay the existing labels against the 70 symbols of Appendix A of NOM-137-SSA1-2025.
• Close the gaps on intended use, manufacturing date and catalogue number or model or version number first, as these are the new mandatory items most easily missed.
• Design the electronic label on the principle of supplementing without replacing, keeping the critical information physically presented.
• Plan in-Mexico relabelling capability for imported products, to be completed after customs clearance and before market release.
• Have the registration holder participate substantively in the review of labelling and instructions for use, rather than in name only.

5. Verification checklist

• □ The publication date of DOF 2026-05-19 and the entry-into-force milestone (approximately 14 May 2027) have been recorded.
• □ The stock sell-off period (180 calendar days) is reflected in the production plan.
• □ The symbol library has been re-laid against the 70 symbols of Appendix A.
• □ Intended use, manufacturing date and catalogue number or model or version number have been completed.
• □ The electronic label complies with the supplement-without-replacing principle.
• □ The relabelling process is scheduled after customs clearance and before market release.
• □ The registration holder has participated substantively in the review of labelling and instructions for use.

Legal information verified as of 28 October 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