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NOM-241-SSA1-2025 — Good Manufacturing Practices

NOM-241-SSA1-2025 (Buenas Prácticas de Fabricación para Establecimientos Dedicados a la Fabricación de Dispositivos Médicos) is Mexico's mandatory GMP standard for medical devices.

Publication and entry into force​

  • Published: in the Diario Oficial de la Federación (DOF) in 2025.
  • In force: April 2025.
  • Replaces: NOM-241-SSA1-2021.

Issuing authority​

Issued by the Secretaría de Salud (Ministry of Health) through COFEPRIS, under the authority of the Ley General de Salud and the Ley Federal sobre Metrología y Normalización.

Scope​

NOM-241 applies to:

  • All manufacturing establishments for medical devices (Class I, II, III) marketed in Mexico.
  • Importers — must demonstrate that the foreign manufacturer meets equivalent GMP requirements.
  • Storage and distribution facilities — Chapter 19 applies to all warehousing and distribution operations.
  • MRHs — responsible for ensuring GMP compliance in their supply chain.

Key changes from NOM-241-SSA1-2021​

ChangeDetail
Classification chapter removedDevice classification rules now exclusively in the Reglamento and the Mexican Pharmacopoeia
Sample retention consolidatedAll sample retention requirements in a single chapter
Mexican Pharmacopoeia alignmentClassification references updated
SaMD acknowledgementSoftware as a Medical Device provisions included

ISO 13485 equivalency​

COFEPRIS formally recognises ISO 13485:2016 certification as meeting NOM-241 GMP requirements. Key implications:

  • ISO 13485 certificates issued by UKAS, DAkkS, ANAB, or other IAF-recognised accreditation bodies are accepted.
  • MDSAP audit certificates are also accepted.
  • Manufacturers already ISO 13485 certified do not need a separate Mexican QMS assessment.

Official text access​

The full NOM-241-SSA1-2025 text is available through:

  • DOF (dof.gob.mx) — search "NOM-241-SSA1-2025".
  • COFEPRIS website — regulatory requirements section for medical devices.

Unofficial English translations of prior NOM-241 versions may be available from third-party sources, but these are not official documents and should not be relied upon for compliance determinations. Always refer to the official Spanish text published in the DOF.

ISO 13485 equivalency – Partial scope coverage: Manufacturers with ISO 13485 certification that does not cover all device categories they market in Mexico must ensure the certificate scope explicitly includes the relevant medical device classification(s). If your ISO 13485 certificate excludes certain device types, those devices must still undergo GMP assessment by COFEPRIS or be manufactured under a separate validated system. Confirm scope alignment with your MRH before submission.