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 IV 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.)
The Canadian guidance targets manufacturers of applicable medical devices who opt not to submit premarket license applications or amendments applications using Summary Technical Documentation (STED) formats developed by the Global Harmonization Task Force and adopted by Health Canada.
Incorporating feedback from manufacturers and other medical device stakeholders, the guidance went into effect July 4, 2012. Going forward, manufacturers must submit medical device applications either in STED format or that outlined in the new guidance.