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Medical Device License

Health Canada clarifies “significant change” qualifications to Medical Device Licenses following Sterigenix shutdown

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada clarifies which changes in sterilization processes would require Medical Device License amendment applications;
  • Impact of Sterigenics sterilization facility in the US on MDL holders still being assessed.

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.)