Health Canada issues notice regarding regulation for commercially reprocessed single-use medical devices

Health Canada has issued notice for the companies that reprocess and distribute medical devices originally authorized and labelled for single-use to Canadian healthcare facilities. Medical devices that are licensed by Health Canada to be used only once or on a single patient during a single procedure are currently being reprocessed and reused. In 2015, large numbers of third-party companies are reprocessing medical devices and distributing to various Canadian healthcare facilities.

 Until this recent amendment, companies reprocessing single-use medical devices had not been required to comply with Canada’s Medical Devices Regulations. After the notice the companies are required to meet requirements for licensing, quality system management, labelling, investigating and handling complaints, maintaining distribution records, conducting recalls, reporting incidents and informing Health Canada of any changes to the information which is given in their license application. According to new labelling requirements, the reprocessor will be required to be listed as the manufacturer of the reprocessed device. According to Health Canada all commercially reprocessed single-use medical devices have to comply with Canada’s Medical Devices Regulations by September 1st 2016.