Tarius national expert summaries are original documents written by Tarius' national experts, providing updated information about the practical implementation of the international guidelines and "best practices" in a particular country.
The summaries cover all major aspects of the product life cycle from product development to the post-marketing period.
Country by country, following the same table of contents and answering the same set of questions, Tarius national expert summaries give a general overview of the national procedures and requirements related to essential issues such as:
device classification, quality systems requirements, clinical trials, marketing approval/clearance applications, establishment registration, packaging and labeling, reporting, recalls (field actions), advertising and promotion, device tracking, inspection of manufacturing sites, sale to consumers, data protection, import/export, pricing and reimbursement, enforcement, and more.
In total, Tarius offers more than 20 national expert summaries per country.
All expert summaries include a reference section with direct links to the source documents from the national authorities. The national expert summaries are reviewed every month.
Contact us to learn more about our expert summaries.