Robert Keur

StarFish Analysis: Health Canada online publication of Regulatory Decision Summaries (RDS)

Health Canada Flag logoHealth Canada has announced, as part of the Regulatory Transparency and Openness initiative, online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review. This means more information about medical devices will be available to consumers, and more importantly, health care providers.

The Health Canada website currently includes a medical device license database. The information is minimal and it really just confirms that a device is licensed by Health Canada. In contrast the FDA website features a summary of the clearance (the FDA doesn’t license devices) with some details of what was included in the clearance submission.

Initially the Health Canada website will only contain information on class IV devices. These are the highest risk devices and so arguably, the ones health care providers are most interested in. We will have to wait until the first of these is published in April to see what is included and hopefully the system will evolve to address the needs of health care providers.

Image: Government of Canada

Leave a Reply

Your email address will not be published. Required fields are marked *

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks