On March 19, 2019, Health Canada published a Notice, announcing the launch of its e-Learning tool: Understanding How Medical Devices are Regulated in Canada – Premarket Regulation. According to the Notice, the tool will offer an overview of Health Canada’s premarket regulatory requirements for medical devices and provide targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.
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Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices
On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing).Read More -
Certificate of Supplementary Protection filing fee increase effective April 1, 2023
On April 1, 2023, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,952 to $10,152 in accordance with subsection 9(1) of the Certificate of Supplementary Protect...Read More