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Medical Device License

Health Canada Establishing Regulatory Framework for Software as a Medical Device (SaMD)

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada proposing regulatory requirements for software as a medical device (SaMD).
  • Proposed Health Canada regulations for SaMD based on International Medical Device Regulators Forum (IMDRF) guidelines.
  • Health Canada SaMD regulations would exclude products such as electronic health records and wellness apps.

Final Guidance on Class III, IV Device Licensing from Health Canada

Health Canada has released final guidance on supporting evidence requirements for Class III and Class IVC medical device license applications. The guidance specifies scientific information requirements for manufacturers submitting Class III and Class IV device license applications, excluding makers of Class III and IV IVD products. (Health Canada plans separate updated guidance on higher-risk IVDs in the future.)