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.
This article highlights the critical points related to the procedures to be followed by medical device manufacturers and other parties involved in case changes to medical devices allowed for marketing and use in Canada.
The new article describes specific types of changes to medical devices in detail and outlines the critical points related to the regulatory status thereof.
The article highlights the critical points related to the concept of significant changes in the context of medical devices allowed for marketing and use in Canada.
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...
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