In-House IVD Manufacturers Get Extra Time To Comply With IVD Directive
This article was originally published in The Gray Sheet
Executive Summary
UK health institutions that manufacture in vitro diagnostics "in-house" and are subject to the IVD Directive will have until the end of 2005 to come into compliance with directive requirements
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International News In Brief
Hong Kong launches device regs: Department of Health releases 1public consultation paper July 4 on proposed regulatory framework addressing Hong Kong's lack of device premarket controls, formal adverse event reporting system and surveillance network. A new risk-benefit approach, in line with Global Harmonization Task Force principles, requires registration and personnel limits for higher-risk devices. DoH will hold three public forums in July on the consultation, which expires Sept. 30. An administrative control system proposal is scheduled for implementation next year...