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National Institute of Health and Family Welfare (NIHFW) National Institute of Health and Family Welfare (NIHFW)

1st RTP on Medical Device Regulation

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1st RTP on Medical Device Regulation

About the Course

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  • Overview of Regulatory Framework

    PDF

  • Materiovigilance - Adverse Event Reporting and Analysis

    PDF

  • Performance Evaluation Clinical Performance Evaluation of In- Vitro Diagnostic Kits

    PDF

  • Medical Device Risk Classification

    PDF

  • Design Controls Training Package Final

    PDF

  • Design Controls For Medical Devices

    PDF

  • Medical Device Risk Management -

    PDF

  • Quality Management Systems

    PDF

  • Testing of medical devices - TIC

    PDF

  • Transition Licensing on Sugam portal

    PDF

  • Regulatory Requirements on IVD Instruments

    PDF

  • Stability Study Requirements for IVD Kits including Reagents

    PDF

  • Certificate

    CDSCO Certificate

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This course includes

  • Video
  • Learning Content
  • Assessment
  • Discussion Forum
  • Feedback

For technical (platform) related queries, contact:

Nodal Officer, SAKSHAM
Dr. Dharmendra Kumar Yadav
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 225

Assistant Nodal Officer, SAKSHAM
Dr. Raj Narayan
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 327
Email - support.saksham@nihfw.org

Department of Statistics & Demography (S&D) NIHFW, New Delhi - 110067
Website : www.nihfw.org

For NMCN related queries, contact:

Dr. Avdesh Chandra
Project Consultant, National Resource Centre, National Medical College Network, AIIMS, New Delhi - 110608
Contact - +91-9910675076, +91-9818664747
Email - nrcsetfacility@aiims.edu