Canada
The present article highlights the key points related to the changes the Canadian authority intends to introduce in order to mitigate the risks associated with potential shortages in the supply of healthcare products intended to be marketed and used in the country.
Canada
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
Canada
The new article outlines the key considerations based on the class of the medical devices in question under the applicable risk-based classification system.
Canada
The new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.
Canada
The new article highlights certain specific matters to be addressed in all the applications for a medical device license in order to ensure the authority is provided with all the information needed to assess the safety and effectiveness of the product subject to review.
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