Sep 29, 2023
Canada
The article highlights the aspects related to the regulatory status of such categories as “medical device group”, “medical device group family” and “medical device system”. Table of Contents Health Canada, the Canadian regulating authority in the sphere of healthcare...
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Jan 27, 2023
Canada
The new article highlights the key points related to comparator devices in the context of submitting clinical evidence when applying for marketing approval. Table of Contents Health Canada, a country’s regulatory agency in the sphere of healthcare products, has...
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Jan 16, 2023
Canada
The new article highlights the aspects related to situations when clinical data is not needed, as well as to the changes to medical devices and amendments to the respective applications. Table of Contents Health Canada, a country’s regulating authority in the sphere...
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Dec 7, 2022
Canada
The new article describes in detail the aspects related to the submission of clinical evidence in the context of applications for marketing approval. Table of Contents Health Canada, a country’s regulatory agency in the sphere of healthcare products, has published a...
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Dec 6, 2022
Canada
The article provides an overview of the regulatory requirement related to clinical evidence for medical devices. Table of Contents Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to...
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