Medical Devices


Medical Device Active License Listing (MDALL) MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. This system has been designed to help health care workers, who are contemplating the purchase of a Class II, III or IV medical device, to verify that the manufacturer has an active medical device licence.
Medical Device Incident Reports Listing of Medical Device incidents reported to Health Canada. The incidents in this database represent the perspective of those who send Health Canada the reports.
Report a medical Device Problem (For Health Care Professionals) The incident reporting provisions in the Medical Device Regulations are intended to improve monitoring and reduce the recurrence of incidents related to medical devices in Canada, and to ensure that the risk to Canadians of problematic devices is managed appropriately. Mandatory reporting is required for health care professionals when certain criteria are met.
Search Regulatory Decision Summaries The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Search Summary Basis of Decisions The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
Search Summary Safety Reviews A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
More Information About Medical Devices Additional information on Medical Devices and links on Medical Device topics.