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MEDICAL DEVICES Medical devices are increasingly being regulated by the national authorities in ways that are parallel to the established regime for human drugs. Tarius’ solution for medical device companies covers national authorities’ regulations for the entire product life cycle. The specifications for the solution were co-developed with GE Healthcare. 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 device 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: • 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 2. National Authorities Documents |
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