Mexico Updates Medical Device Labelling Requirements: What the New NOM-137-SSA1-2025 Means for Industry

What's Changed?

On 19 May 2026, Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published the final version of NOM-137-SSA1-2025, the country's updated labelling standard for medical devices.

The new standard introduces important revisions to labelling and Instructions for Use (IFU) requirements, updates key regulatory definitions, clarifies manufacturer responsibilities, and aligns several provisions more closely with internationally recognised regulatory frameworks.

Although the standard will enter into force in May 2027, manufacturers should begin assessing its impact now to ensure sufficient time for implementation and compliance.

Why This Change Matters

Medical device labelling plays a critical role in product safety, regulatory compliance, and market access.

The updated standard goes beyond editorial revisions by introducing new expectations regarding:

• Device labelling content

• Instructions for Use (IFU)

• Manufacturer and registration holder responsibilities

• Single-use device identification

• Safety-related information

• Software as a Medical Device (SaMD) labelling considerations

For companies marketing products in Mexico, these changes may require updates to existing labelling strategies and documentation before the implementation deadline.

Who Needs to Pay Attention?

This regulatory update is particularly relevant for:

✔ Medical device manufacturers

✔ Registration holders

✔ Authorised representatives

✔ Regulatory affairs professionals

✔ Quality and compliance teams

✔ Companies planning market entry into Mexico

Organisations with products already registered in Mexico should evaluate how the revised requirements may affect existing product documentation.

What Companies Should Do Next

1. Conduct a Labelling Gap Assessment

Review current labels and IFUs against the new requirements to identify potential updates well before the implementation date.

2. Review Internal Documentation

Ensure technical documentation, intended use statements, and safety information remain consistent across regulatory submissions and product labelling.

3. Engage Cross-Functional Teams

Labeling changes often require coordination between regulatory affairs, quality assurance, manufacturing, marketing, and translation teams.

Early planning can help minimise implementation challenges.

4. Monitor Additional Regulatory Guidance

As implementation approaches, companies should continue monitoring COFEPRIS communications for further clarification and supporting guidance.

ARQon Insight

Labelling requirements are often viewed as administrative obligations.

In reality, they represent one of the most visible expressions of regulatory compliance and directly influence product safety, user understanding, and market acceptance.

Mexico's updated labelling standard reflects a broader shift toward clearer communication, stronger accountability, and greater international alignment.

Organisations that prepare early will be better positioned to implement changes efficiently while minimising operational disruption.

🌍 Global Regulatory Trend

Mexico's revised labelling requirements mirror a broader international movement toward harmonised medical device regulations.

Across global markets, regulators are placing increased emphasis on clearer product information, enhanced traceability, improved Instructions for Use, and greater manufacturer accountability.

As healthcare regulations continue to evolve, companies with globally aligned labelling strategies will be better equipped to support efficient market access across multiple jurisdictions.

Key Takeaway

Mexico's publication of NOM-137-SSA1-2025 represents an important regulatory milestone for the medical device sector.

While implementation is scheduled for 2027, manufacturers should begin preparing now by reviewing labelling practices, strengthening documentation, and integrating the new requirements into long-term regulatory planning.

Early preparation will help reduce compliance risks and support a smoother transition when the standard becomes fully enforceable.

How ARQon Can Support

ARQon supports healthcare and life sciences companies with:

• Regulatory intelligence and monitoring

• Medical device regulatory strategy

• Labelling and IFU compliance reviews

• Market access planning

• Global regulatory consulting

• Cross-border compliance support

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.