New label standard for medical devices published
Published 19 May 2026 · Diario Oficial de la Federación
What changed
NOM-137-SSA1-2025 sets the health-information label for medical devices for human use, including traceability. It replaces NOM-137-SSA1-2008 when it enters into force, 360 calendar days after publication, with 180 more days to use up existing packaging.
Who it affects
Dental and medical, Health, pharmacy and OTC. Product types on our rules page: Medical devices.
The source and its dates
Diario Oficial de la Federación, via SIDOF (Secretaría de Gobernación). Published 19 May 2026; enters into force on 14 May 2027 (360 calendar days after publication, by our count). Checked against the source on 11 October 2026.
What to do
If you sell medical devices into Mexico, have your registration holder or importer check every label against NOM-137-SSA1-2025 before 14 May 2027. Packaging already printed to the 2008 standard can be used for 180 days after that, so time new print runs to the new standard rather than reprinting twice.
Your customs broker, accountant or lawyer files and signs; this page sets out the rule and its source. Need it for your own case? Write to us.