China NMPA Regulations and Processes for Medical Device In Vitro Diagnostics (IVD)

12.0
RAC Credits
Online Workshop
Monday, 16 August 2021 (9:00 AM) - Tuesday, 17 August 2021 (5:00 PM) Eastern Time (US & Canada)

This workshop will focus on China’s NMPA regulations for In Vitro Diagnostics (IVD) products, exploring the unique requirements, processes, and approval criteria for reagent products, in comparison to regulations for IVD instruments. This workshop will present a systematic review of all elements in the Chinese regulations from clinical trial, to quality management, product registration and post market surveillance.

By participating in this workshop, attendees will be able to:

  • Understand NMPA’s regulations, processes and requirements for IVD product registration. 
  • Identify key factors that would affect regulatory strategies and prepare for necessary adjustments.
  • Gain up-to-date knowledge of current requirements and practices.
  • Discuss their specific issues with presenters and other participants.
  • Led by instructors who are veteran regulatory managers, this workshop will also incorporate personal experience, knowledge, up-to-date information and best practices.

    This workshop is suitable for professionals with more than three years of experience, looking to broaden their knowledge base on international regulations or to focus on the Chinese market in the near future.


    Pricing Amounts & Deadlines

      19 November 2020 – 15 July 2021: Early Bird $800 Member | $900 Nonmember
      16 July 2021 – 15 August 2021: Regular $900 Member | $1000 Nonmember 


      Agenda

      Day 1   Monday, 16 August 2021

                  9:00 - 9:15 am           Welcome, introduction of speakers and class schedule

                  9:15 - 10:45 am         NMPA - structure, responsibilities, and key regulations

                 10:45 - 11:00 am         Break

                 11:00  - 12:00 pm       Classification and testing

                  12:00 - 1:00 pm         Lunch

                  1:00 - 2:30 pm           Clinical Evaluation and Clinical Trial

                  2:30 - 2:45 pm           Break

                  2:45 - 3:45 pm           Pathways: traditional vs. new

                  3:45 - 4:15 pm           Panel discussion

       

      Day 2   Tuesday, 17 August 2021

                  9:00 - 10:30 am         Pre-submission: dossier, key documents and filing review

                  10:30 - 10:45 am         Break

                  10:45 - 11:15 am         Submission and review by NMPA, consultation with NMPA

                  11:15 - 12:00 pm         Amendments and renewal

                  12:00 - 1:00 pm           Lunch

                  1:00 - 2:00 pm             Post-market Risk Re-evaluation and its comparison to EU MDR requirements

                  2:00 - 3:00pm              Quality - Manufacturing, distribution, field inspection; UDI

                  3:00 - 3:15 pm             Break

                  3:15 - 3:45 pm           Strategic considerations for China

                  3:45 - 4:15 pm           Panel discussion

       

      *All agendas are subject to change

      Speaker


      Chang-Hong Whitney  RAC MBA
      President & CEO, Whitney Consulting Ltd.

      Chang-Hong Whitney has spent more than 30 years in the medical device industry in both China and the US. She founded Whitney Consulting Ltd., focusing on Chinese regulations for medical devices and IVDs, servicing exclusively international clients around the world, including Fortune 500 companies. Whitney is an active member of the RAPS community, presenting China regulatory updates at RAPS conferences, organizing workshops and seminars, editing educational material, and serving on volunteer committees. She holds an MBA from Babson College and undergraduate degrees in electrical engineering and international business in China.

      Cancellation Policy

      RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

      All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

      Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

      If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.