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Manager, Device Evaluation Division Medical Devices Bureau Therapeutic Products Directorate Health Canada Room 1605 Main Building 150 Tunney's Pasture Driveway Address Locator: 0301H1 Ottawa, Ontario K1A 0K9 Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations.Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.Class II, III and IV medical devices sold in Canada are required to be licensed under section 26 of the Regulations.Section 34 of the Regulations describes five instances when a manufacturer is obliged to apply for an amended medical device licence.(Regulations) set out the requirements governing the sale, importation and advertisement of medical devices.The goal of the Regulations is to ensure that medical devices offered for sale in Canada are safe and effective and meet quality standards.Louise works with a team of specialists with diverse knowledge in psychology, social work, and clinical pharmacy, which provides an open-mind attitude and compassionate outlook.For more than twenty years, Louise worked in the medical field going above and beyond her duties to help patients who were disabled or handicapped in any way.

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One of those instances is when a "significant change" is proposed to a Class III or IV device.

This guidance document elaborates upon the definition of "significant change" in the Regulations, in order to assist manufacturers in determining whether a change proposed to a class III or IV medical device requires the submission to Health Canada of a licence amendment application, prior to introducing the device to the market.




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