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China's NMPA: The Evolution of Medical Device Regulation

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Menu
  • Home
  • About
    • About Us
    • Our Team
    • Testimonials
  • Regulatory
    • RA Strategy
      • NMPA Classification
    • China NMPA Product Registration
    • QMS, PMS
    • In-country Representation
    • IVD & CDx
    • SaMD
  • CRO
    • Clinical Trial Services
    • Overseas Clinical Data
    • Clinical Evaluation Report (CER)
    • Real World Data (RWD)
      • Hainan Real-World Data/Study
  • Commercialization
  • Resources
    • Regulatory Intelligence Portal
    • NMPA (CFDA) Regulations
    • NMPA (CFDA) Newsletters
    • Brochures
    • White Papers
    • Recorded Webinars
    • Events
    • FAQs
  • Blog
  • Contact
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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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    NMPA (CFDA) Updates

    Ten IVD Guidelines Issued in One Day

    One Step Forgotten: Submitting Your Medical Device Master Files to NMPA

    NMPA Roundup July 2022

    Latest Resources

    China’s NMPA: The Evolution of Medical Device Regulation

    2021 NMPA CFDA Key Updates and Look Ahead on 2022

    202110 NMPA (CFDA) Newsletter

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