Global Harmonization of Medical Devices in Canada

| 01 June 2008

Concerns over the quality and safety of imported medical devices that adhere to varying regulatory standards have long been recognized in Canada and globally. Canada has been involved with harmonization initiatives, including the foundation of the Global Harmonization Task Force (GHTF) and participation in GHTF activities, for more than 15 years. Despite the development and adoption of guidance documents by GHTF, little progress is apparent at the national level. This article discusses Canada's role in the harmonization of regulatory practices for medical devices, the impact of GHTF policies on the regulation on medical devices in Canada and challenges to the harmonization of medical devices on a global scale.


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