The control of medical devices in Canada. Canadian Society of Laboratory Technologists.

Medical devices should not be allowed into Canada until they have been approved by a Canadian Regulatory Agency. The approval process should be carried out expeditiously in order to ensure timely availability of medical devices to Canadians, BUT the protection of the public must always be paramount in regulatory decisions. Premarket review of devices should include: a) Testing by the manufacturer to ensure that they operate efficiently b) testing by the manufacturer to validate that they can be operated effectively by the targeted user group(s) c) review of published reports d) investigation of experience with the device in other jurisdictions, through a network of contacts with regulatory agencies in other countries e) if the agency requires it, independent testing of the device should be performed at the expense of the manufacturer Post market surveillance should include: a) adverse incident reporting by health professionals which must be confidential b) review of published reports c) ongoing review of experience with the device in other jurisdictions d) dissemination of adverse experience reports to health care professionals Availability of medical devices should be restricted to situations where they are prescribed and monitored by appropriately-trained health care professionals. The effectiveness of the existing Bureau of Medical Devices should be evaluated. Adequate resources must be provided to a Canadian Regulatory Agency to enable it to ensure that medical devices meet the public's expectations for safety and effectiveness.