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.
Canada
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.
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices already placed on the market. The document is intended to assist medical...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the interpretation of significant changes to a medical device. In particular, the guidance describes...
