Health Canada Issues Animal Tissue Device Guidance
Health Canada issued guidance on 30 September 2013 that outlines the safety requirements for marketing approval and investigational testing applications for new medical devices that are manufactured from or contain animal tissue.
Medical devices manufactured from or incorporating non-viable or viable animal or human tissue or their derivatives are classified in Canada as Class IV devices, which require the submission of detailed information substantiating the adequacy of the measures taken with regard to risks associated with transmissible agents.
This guidance applies only to medical devices incorporating animal materials that have been processed, combined with non-tissue components, or that may have a systemic effect on the body. This includes wax, coral, collagen, gelatin, silk, hyaluronic acid and material obtained from animal cell lines.
Devices that are manufactured from human tissues or their derivatives are excluded from this document, as are in vitro diagnostic devices and devices intended to come into contact with intact skin only.