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Medical Device

USA: FDA Modifies List of Standards for Premarket Device Reviews

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USA: FDA Drafts Guidance on Patient Engagement in Device Trials

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China: NMPA Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme

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Uncertainty as a Factor in Determining Benefit-Risk for Pre-market Approval of Medical Devices

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European Medicines Agency Seeks Public Opinion on Draft Guideline on Quality Requirements for Medical Devices

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