What is NOM-137-SSA1-2008 and why is it important?

NOM-137-SSA1-2008 establishes labeling requirements for medical devices in Mexico. Published September 22, 2008, it ensures user safety through proper information. Mandates Spanish language, required content, symbol standards.

What medical devices are covered under NOM-137-SSA1-2008?

Applies to all medical devices marketed in Mexico, including domestic and imported products. Covers equipment, instruments, implants, reagents, materials. IVD devices also included. No device category exempt.

What are the language requirements for medical device labels?

Spanish mandatory for all labels and instructions. Technical terms without Spanish equivalent allowed in original language. Multilingual labels acceptable if Spanish appears first. Font size minimum 1.5mm for critical information.

What information must appear on the device label?

Manufacturer name/address, authorized representative in Mexico, product name/model, lot/batch/serial number, manufacturing date, expiration date (if applicable), storage conditions, registration number, sterilization status, single-use warning.

What are the specific requirements for sterile medical devices?

Sterile devices must display 'ESTERIL' or 'STERILE' prominently. Sterilization method indicated. Expiration date mandatory. Package integrity indicators required. Opening instructions provided. Warning about re-sterilization included.

What labeling is required for single-use medical devices?

Must display 'UN SOLO USO' (single use) or international symbol. Warning against reuse prominently placed. Rationale for single-use in IFU. Risks of reprocessing explained. No reprocessing instructions provided.

What must be included in Instructions for Use (IFU)?

IFU must include intended use, contraindications, warnings, operating instructions, maintenance, storage, troubleshooting. Entirely in Spanish. Required unless device use is self-evident. Illustrations recommended.

When can Instructions for Use be omitted?

IFU exemption only if device use is completely self-evident. Simple non-invasive devices with no special handling. All safety information still on label. Exemption rare and requires justification.

What symbols can be used on medical device labels?

International symbols from ISO 15223-1 acceptable. Must be widely recognized. Each symbol explained in IFU. Critical safety information cannot rely solely on symbols. Country of origin allowed as text or symbol.

How should symbols be explained in the Instructions for Use?

Include dedicated section listing all label symbols. Show symbol with Spanish explanation. Logical grouping (safety, handling, identification). ISO 15223-1 reference acceptable. User-friendly presentation essential.

What are the requirements for packaging labels?

Primary packaging must have full label. Secondary/transport packaging needs identification, quantity, storage conditions. Inner packages for sterile devices require sterile markings. Shelf boxes need enough info for selection.

Are electronic Instructions for Use (eIFU) acceptable in Mexico?

Electronic IFU acceptable for professional-use devices with patient-level paper copy available upon request. Consumer devices need paper IFU included. Website link acceptable if reliable access ensured. QR codes increasingly accepted.

How are label changes handled after registration?

Label changes require COFEPRIS notification or approval. Major changes (safety, indications) need pre-approval. Minor changes (contact info, formatting) reported post-implementation. Updated labels submitted. Proper change control maintained.

NOM-137-SSA1-2008 FAQ - Updated October 2025

Mexico Labeling Requirements for Medical Devices. Expert guidance by Pure Global regulatory specialists

COFEPRIS Regulation

Effective September 22, 2008

Labeling Standards

Spanish Required

Official Document

Access the official document:Download NOM-137-SSA1-2008 (Spanish PDF)

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Language

Spanish

Required for all labels

Symbols

ISO 15223-1

Internationally recognized

Authority

COFEPRIS

Health regulatory agency

Instructions

IFU Required

Unless self-evident use

Frequently Asked Questions

On This Page

General Questions

Label Content Requirements

Instructions for Use

Symbols & Pictograms

Packaging & Special Requirements

Quick Resources

All Mexico Regulations Mexico How-To Guides Pure Global Mexico Services

Key Dates & Milestones

PublishedSep 22, 2008

EffectiveSep 22, 2008

StandardISO 15223-1

Quick Checklist

All text in Spanish

Mandatory information present

Symbols explained in IFU

Complete Instructions for Use

Legible and permanent markings

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Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on NOM-137-SSA1-2008 official documentation