Health Canada Clarifies Position on Light-Based Medical Devices

Overview

Food and Drug Law
Food and Drug Regulatory LawHealth Canada has released a notice regarding the agency’s position on scientific evidence required to demonstrate an acceptable risk-benefit ratio for light-emitting medical devices indicated primarily for cosmetic or therapeutic treatments where the light source is key to the claimed mechanism of action.

Specifically, Health Canada states that “Manufacturers will need to include data which clearly demonstrates that all hazards related to potential thermal damage to the skin have been removed or sufficiently mitigated by product design. The risk-benefit analyses should demonstrate that all patient risks have been thoroughly assessed and that all reasonable mitigations have been implemented.”  Effective as of February 9, 2016, Medical Device License applications for Class III and IV devices in Canada will need to include detailed skin temperature testing quantifying induced temperature over time.

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