Health Canada Guidance on Applications for Medical Devices: Basic Info
The new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.
The new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.
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.
The new article describes in detail the authority’s review process when assessing applications related to medical devices.
The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market.
The article highlights the critical points related to the recall procedures applicable to medical devices allowed for marketing and use in Canada.
The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved.
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