IVDs
In Vitro diagnostic devices are increasingly being regulated by the national authorities in ways that are parallel to the established regime for human drugs and/or biologics. Tarius’ solution for IVD companies covers national authorities’ regulations for the entire product life cycle.
1. National Expert Summaries
The national expert summaries are original locally written documents providing updated information about the practical implementation of the international regulations, guidelines and “best practices” in a particular country. The summaries cover all major aspects of the IVD 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, our National Expert Summaries give a general overview of the procedures and requirements related to essential issues such as:
• IVD definition, including when they are regulated or not and by a which
_Health Authority
• Laboratory certifications required (if any)
• Quality systems requirements
• Clinical trials
• Performance evaluation
• Regulatory pathways, marketing approval/clearance applications
• Establishment registration
• Packaging and labeling
• Reporting, recalls (field actions)
• Advertising and promotion
• Over the counter IVDs
• Inspection of manufacturing sites
• Sale to consumers
• Data protection
• Import/export
• Pricing and reimbursement
• Enforcement
• And more.
2. National Authorities Documents
Tarius monitors national authorities’ websites and national official journals in order to provide draft, current and archive versions of relevant acts, regulations, directives, decisions, policy papers, guidelines, warning letters, enforcement documents, press releases, forms, and more. In addition, Tarius monitors a number of important international organizations’ websites, such as GHTF, Eucomed and ISO. Newly published information is added to our web portals on the day of publication.
Every document in Tarius contains abstract, keywords and status information in English enabling users to identify important national documents through searching in English, even if they are unfamiliar with the local language.
