Health Canada Draft Guidance on Use of Standards: Overview
The article provides a brief overview of the approach to be applied when using standards for demonstrating compliance with the relevant regulatory requirements.
The article provides a brief overview of the approach to be applied when using standards for demonstrating compliance with the relevant regulatory requirements.
The new article explains further the way the approach described in the document should be implemented.
The present article highlights the key points related to the changes the Canadian authority intends to introduce in order to mitigate the risks associated with potential shortages in the supply of healthcare products intended to be marketed and used in the country.
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
The new article outlines the key considerations based on the class of the medical devices in question under the applicable risk-based classification system.
The article provides a general overview of the approach to be followed when applying for a medical device license necessary to place a new product on the market.