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...
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...
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...
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...
Canada
The article describes the regulatory changes proposed by the Canadian authority and clarifies their potential impact on the market and all the parties involved. Table of Contents Health Canada, the country’s regulating authority in the sphere of...
Canada
Health Canada, a country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the investigation of reported medical device problems. The document provides additional clarifications regarding the applicable...
