Health Canada Draft Guidance on Significant Changes: Types of Changes
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 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 Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...
This article highlights he current regulations for medical devices in Canada, the process of registering compliant devices, potential changes being considered, and the potential impact on stakeholders. Table of Contents The use of medical devices is essential in...
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...