Labelling — NOM-137
COFEPRIS · NOM-137-SSA1-2025 (published May 2025, in force May 2027)
Medical device labelling in Mexico is governed by NOM-137-SSA1 (Norma Oficial Mexicana para el etiquetado de dispositivos médicos). All medical devices marketed in Mexico must carry a Spanish-language label compliant with NOM-137.
NOM-137-SSA1-2025 was published on 19 May 2025 and enters into force on 14 May 2027, replacing NOM-137-SSA1-2008. Devices registered before the 2027 date may continue to use NOM-137-2008-compliant labels until that date, but new registrations submitted from May 2027 onward must comply with the 2025 version. Begin transition planning now.
Core Labelling Requirements
Required Under NOM-137-SSA1-2025
| Element | Requirement |
|---|---|
| Device name | Generic name and trade name |
| Intended use | Statement of intended purpose (new requirement in 2025 version) |
| Manufacturer details | Name and address of manufacturer |
| MRH details | Name, address, and sanitary registration number of the Mexico Registration Holder |
| Registration number | COFEPRIS sanitary registration number (homoclave) |
| Catalogue / model number | Catalogue or model number (explicit requirement in 2025 version) |
| Lot/batch number | Or serial number, as applicable |
| Manufacturing date | Manufacturing date (explicit requirement in 2025 version) |
| Expiry date | As applicable |
| Instructions for use | In Spanish; full IFU must be supplied |
| Storage conditions | Temperature, humidity, light requirements |
| Single-use designation | "Para uso único" — if applicable |
| Sterility statement | Method and status if device is supplied sterile |
| Warnings and precautions | In Spanish |
| Adverse incident instructions | Instructions on what to do in the event of an adverse incident (new in 2025 version) |
Language Requirement
All labelling and Instructions for Use must be in Spanish:
- Official certified Spanish translations are required for devices from non-Spanish-speaking countries
- The foreign-language label may be used for registration dossier reference, but devices placed on the Mexican market must carry a Spanish label
- Bilingual labels (Spanish + origin language) are acceptable, provided Spanish text is not relegated to smaller font or less prominent placement
Certified Translation Requirements
Official certified Spanish translations must:
- Be prepared by a professional translator certified by the Mexican government (traductor certificado) or a recognized equivalent
- Include a certification statement confirming accuracy and completeness of the Spanish version
- Cover all text on the label and in the Instructions for Use, including warnings, storage conditions, and contraindications
Maintain the certified translation document in your regulatory file — COFEPRIS may request it during inspections or at renewal.
Symbols
Standard ISO 15223-1 symbols may be used on labels, supplemented by Spanish text where COFEPRIS specifically requires it. Ensure symbols used are current (ISO 15223-1:2021).
IFU — Instructions for Use
A full Spanish-language IFU must accompany the device. It must cover:
- Intended use and indications
- Contraindications
- Instructions for use, care, and maintenance
- Warnings and precautions
- Expected performance (for IVDs: analytical and clinical performance)
Electronic IFU
NOM-137-SSA1-2025 acknowledges that label information may be supplemented with QR codes, RFID, or other electronic media. However, there is no mandatory eIFU framework in Mexico. Physical IFU in Spanish remains the baseline requirement.
No UDI Requirement
Mexico currently has no Unique Device Identification (UDI) requirement. NOM-137-SSA1-2025 does not introduce UDI. Devices from markets with UDI (EU, US, Australia) do not need to adapt UDI labelling for Mexico, though existing UDI codes on labels are acceptable.
Advertising & Promotional Claims
Promotional materials for medical devices must not make claims beyond the approved intended use stated in the sanitary registration. COFEPRIS monitors advertising and can take action against misleading or unsupported claims.