FDAnews Device Daily Bulletin

Canada Offers Guidance on Evidence for Class III, IV Device Applications

Aug. 23, 2012
Makers of Class IV devices that choose not to use a summary technical documentation-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. Applicants should also include a risk assessment and risk-reduction measures that satisfy the agency’s safety and efficacy requirements.
International Medical Device Regulatory Monitor