Simplifying Global Compliance
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
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