Saudi Arabia
The article outlines the basics of the regulatory framework for innovative medical devices.
FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
FDA
The new article describes in detail the approach the authority applies when reviewing De Novo requests about medical devices utilising novel technologies.
Canada
The new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.
