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Where Do Old, Seized Devices Go? Disposal, Reuse Regs Vary Widely
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Team-NB Updates Code of Conduct, Clarifies Technical File Reviews
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India Limits Clinical Investigators to Three Trials Simultaneously
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Turkey Bans Ads on Some Medical Devices, Requires ‘Qualified’ Employees for Sales
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Japan’s PMDA Clarifies Requirements for Companion Diagnostic PMAs
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Australia Expands Access to HIV Testing With OK of Self Tests
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U.S. FDA Says No to Using Split Predicates in ‘Substantial Equivalence’ Applications
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510(k) Guidance Overhauls U.S. FDA’s Risks vs. Benefits Review Process
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SCENIHR Recommends Phased Approach to Risk Evaluation of Nanomaterials
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Report Details Risk Management Needed to Conform to EU’s MDD, Annexes Z
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New MHRA Advisory Committee Designed to Better Head Off Crises
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South Korea to Allow Third-Party Audits of Some Device Companies
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