Health Canada Guidance on Medical Device Recalls: Reporting and Terminology
The new article clarifies the reporting requirements associated with medical device recalls and explains the key terms and concepts used in this respect.
The new article clarifies the reporting requirements associated with medical device recalls and explains the key terms and concepts used in this respect.
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...
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...
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...
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...