Medical device marketing: Application process
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This set of documents discusses the medical device application processes in Canada, the US and Europe. Each provides an overview of the information a regulatory agency will look for in assessing the safety, efficacy and quality of a device.
How Devices are Approved in Canada (PDF)
How Devices are Approved in the US (PDF)
How Devices are Approved in Europe (PDF)
These articles are not intended to provide specific details, but to summarize the likely requirements that must be met before a new device can be commercialized.
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