REGISTRATION PROCEDURE FOR MEDICAL DEVICES IN CANADA AS PER CANADIAN MEDICAL DEVICE REGULATIONS SOR/98-282
G. Star Honey* and Maddi Ramaiah
ABSTRACT
The knowledge and compliance with regulatory requirements is a key to success in development and marketing of medical devices. As the use of medical devices has increased, stringent regulatory standards are required to ensure safety, efficacy and performance of medical devices with least adverse effects. Recently introduced guidelines help to provide adequate guidance for effective registration by competent authorities, manufacturers and importers. Canada follows well developed and specific guidelines “Medical Devices Regulations (SOR/98-282)”. The present article overviews the detailed regulation framework for registration of medical devices in Canada.
Keywords: Global Harmonisation Task force (GHTF), Common Submission Dossier Template, Quality management systems, Filing of medical device licence application, Regulation of medical devices.
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