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June 07 , 2019

Health Canada is exploring how best to address longstanding stakeholder concerns regarding the current regulatory framework for medical devices and how it may be unintentionally limiting investigational testing activity in Canada.

Canada has become a country of choice for developing and testing innovative health products. However, in order to remain competitive in the clinical trial landscape and continue to be responsive to the health needs of patients and interests of investigators, Health Canada is studying how to address longstanding concerns and increase research, while protecting patient safety. This issue was prioritized in Health Canada’s Action Plan on Medical Devices, which was published in December 2018. The Action Plan identified the need to better align the regulatory frameworks for device investigational testing (IT) and drug clinical trials, and to adopt international best practices, where appropriate.

To advance these objectives, Health Canada is now seeking feedback from stakeholders on five key issues regarding the application requirements and processes for medical devices used in investigational testing.

For more information, click here

Please direct your responses to hc.policy.bureau.enquiries.sc@canada.ca by June 21, 2019.

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