Medical Devices

New Transition Regulations to address Interim Orders for Medical Devices Due to the Covid-19 outbreak early this year, the Minister of Health took swift action in March through the introduction of Interim Orders for medical devices. The order’s aim was to safeguard public health by ensuring the availability of adequate medical device supplies.  The interim measures relaxed the importation rules allowing for accelerated authorization, access and sale of products that met Health Canada’s definition of “designated medical devices"; however, that may have not fully met regulatory requirements to be imported and sold. These products included face masks, [...]

Health Canada’s new child-resistant refillable vaping device and part container requirements On November 19, 2020, Health Canada issued a letter to the Vaping Product Industry outlining Health Canada’s planned approach to enforce upcoming new child-resistant container requirements for refillable vaping devices and vaping parts. The new requirements are part of Vaping Products Labelling and Packaging Regulations (VPLPR), which are enacted jointly under the Canada Consumer Product Safety Act (CCPSA) and the Tobacco and Vaping Products Act (TVPA) and come into force on January 1, 2021. The intent of the new requirements is to help protect the health [...]

Modified Approach to Posting Medical Device Recalls Online As part of Health Canada’s risk-based approach to ensure its transparency efforts are focused on Canada’s most important health concerns, including those related to COVID-19, the Department has updated its approach to posting medical device recalls online. As of June 22, 2020, Type III medical device recalls are no longer being posted on Health Canada’s Recalls and Safety Alerts Webpage. This web page can be accessed at https://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=99. Based on the risk evaluation, companies are required to assign a health hazard classification (which are Type I, II and III) [...]

Health Canada’s Final Guidance on Software as a Medical Device On December 18, 2019 Health Canada published a guidance document on Software as a Medical Device (SaMD): Definition and Classification. The role of the document is to clarify to manufacturers and software developers whether their software product meets Health Canada’s definition of a medical device and if so, its applicable risk classification.  The guidance document is an important first step of establishing SaMD policy in Canada under the Food and Drugs Act (Act) and the Medical Devices Regulations. Additional policies will roll out in the future as [...]