Home > Newsletters > Devices & Diagnostics Letter > Canada Outlines Evidence Needs for Class III, IV Device Applications
Devices & Diagnostics Letter
Aug. 27, 2012 | Vol. 39 No. 34
Canada Outlines Evidence Needs for Class III, IV Device Applications
Makers of Class IV devices that choose not to use a summary technical documentation (STED)-based license or amendment application must provide details on manufacturing and quality controls, a device-specific quality plan and process validation studies, according to a Health Canada final guidance.
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