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China's NMPA: The Evolution of Medical Device Regulation

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NMPA Medical Device Registration & Clinical Trial Process 399.40 KB 586 downloads

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Operation Specification for Record Filing of Medical Device Master Files 0.00 KB 57 downloads

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Record Filing Requirement of Medical Device Master Files 0.00 KB 55 downloads

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Guideline for Record Filing of Medical Device Master Files (Draft) 0.00 KB 41 downloads

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Announcement on Record Filling of Medical Device Master Files 0.00 KB 31 downloads

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Innovation Device Approval Procedure 0.00 KB 80 downloads

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Unique Device Identification (UDI) Implementation Plan (draft) 0.00 KB 85 downloads

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Using Chinese Name for Registrant or File Submitter of Imported Medical Devices 0.00 KB 60 downloads

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Regulation on Instructions for Use and Labels of Medical Devices 0.00 KB 112 downloads

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