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 provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA
The new article describes in detail the authority’s review process when assessing applications related to medical devices.
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
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