Swedes publish registration fees for IVDs (in vitro diagnostics):
This article was originally published in Clinica
The Swedish National Board of Health and Welfare has published its registration fees for in vitro diagnostics as part of its transposition of the IVD Directive. The fees range from SKr 500 ($56.2) for up to 10 products to SKr 5,000 for over 500 products. There will also be a registration fee of SKr 1,000 per manufacturer or authorised representative. All CE-marked IVDs will have to be registered in Swedish or English before they can be marketed. Information for the end-user must be in Swedish. The classification has to be in accordance with the European Diagnostics Manufacturers Association classification, until the global medical device nomenclature system is published.