Spanish labelling for imported surgical instruments in Mexico

Medical devices sold in Mexico must carry labels in Spanish that meet the official Mexican standard for medical device labelling, NOM-137-SSA1. Getting labels right before shipping saves time at customs and avoids relabelling costs in Mexico.

This is a summary, not legal advice. Check the current standard and your registration conditions.

What labels usually include

• Product name and description in Spanish
• Name and address of the manufacturer
• Name and address of the importer or registration holder in Mexico
• COFEPRIS registration number
• Lot or batch number
• Country of origin, for example “Hecho en Pakistán”
• Expiry date and sterilisation method for sterile products
• Storage and handling instructions
• Symbols, such as “single use” or “sterile”

Instructions for use

Reusable instruments need instructions for cleaning and sterilisation in Spanish. These can be printed inserts or provided in another approved form.

Labelling at the factory or in Mexico

• At the factory: Cheaper and faster. Your supplier prints Spanish labels before packing.
• In Mexico: Possible in an authorised warehouse, but adds cost and time.

What to send your supplier

1. Your company details as importer
2. Your COFEPRIS registration number, once granted
3. Approved label text and layout
4. Your logo, if you sell under your own brand

Spanish labels from Tata Surgical

We print Spanish labels and inserts to your approved design before shipping. Send us your label file.

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