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.
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
United States
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
United States
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
