
Health Canada Pre-market Guidance for ML-enabled Medical Devices
The article describes in detail the regulatory requirements for certain innovative medical devices.
The article describes in detail the regulatory requirements for certain innovative medical devices.
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 new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.