April, 6, 2023 Health Canada Medical Device System License Components Sold Separately In general, components of a licensed medical device system can be sold separate from the system on the condition that the label of each component bears the system name. Also, strictly speaking based on Health Canada’s CMDR and guidance terminology and interpretations, […]
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Health Canada: Licence Amendment vs New Licence Application
March 9, 2023 Health Canada: Licence Amendment vs New Licence Application Knowing whether an existing Canadian Medical Device Licence can be amended or an entirely new Medical Device Licence is required depends on a number of critical factors/variables. Those critical factors/variables include, but may not be limited to, the licence/device class, licence type, and […]
Health Canada Medical Device Importer Requirements for DTC Sales
July 7, 2021 Health Canada Medical Device Importer Requirements for DTC Sales When dealing with Health Canada’s medical device regulatory requirements (i.e., SOR/98-282 as amended from time to time, hereinafter the “CMDR”), there are four device classes: I, II, III, and IV. Therefore, when adapting a regulatory strategy from surrounding jurisdictions, be sure to […]
Health Canada CMDR Updates 2021
June 28, 2021 Health Canada CMDR Updates 2021 Here’s a quick recap of Health Canada’s changes to the Medical Devices Regulations (SOR/98-282) that started coming into force on 23 June 2021: Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to […]