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  3. /NOM-241-SSA1-2012
SSA1 (Health)PharmaceuticalActive

NOM-241-SSA1-2012

Good manufacturing practices for medical devices

Establishes GMP requirements for medical devices. Applies to domestic manufacturers and importers of medical equipment, prosthetics, orthoses, surgical materials and diagnostic devices.

Last updated: 2024

Affected products

Medical equipmentProstheticsSurgical materialsDiagnostic devicesImplants

Compliance requirements

  • ISO 13485 equivalent quality management system
  • Manufacturing process validation
  • Design and development controls
  • Device traceability
  • Complaint and adverse event management
  • COFEPRIS GMP certification

Related tariff codes

These tariff codes may be subject to this NOM. Check the specific code to confirm.

9018.90.019021.10.019018.39.019022.12.01

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