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REGISTRATION CLOSED-Boston Chapter Webcast: Navigating China’s Medical Device Regulatory Landscape Under NMPA Regulations

RAC Credits
Wednesday, 29 April 2020 (12:00 PM) - Wednesday, 29 April 2020 (1:15 PM) Eastern Time (US & Canada)

Member: $20
Nonmember: $30

Eat your lunch and join the RAPS Boston Chapter online to dive more deeply into the challenges that regulatory professionals face when working on submissions to China’s National Medical Products Administration (NMPA) . China’s medical device regulatory environment has changed dramatically in the last five years. Since NMPA issued regulations in 2014 that sought to improve the quality and safety of medical devices, various reforms have been initiated, and China’s regulatory landscape continues to change. These evolving changes make it challenging to develop strategies to obtain approval and access into the Chinese market.

Engage with professionals from your local regulatory community for an interactive presentation exploring current best practices and requirements to better manage your NMPA submissions. Share your stories of success and challenges in navigating China’s medical device regulatory landscape, while hearing from an industry expert with more than 30 years’ experience in both China and the US. Topics to be covered include:

  • Hear the latest practice NMPA reviewers use to review and approve submissions. Two case studies will be discussed. 
  • Learn how to prepare documents that are unique for NMPA (such as device life, software description file and network security).
  • Get advice on how to utilize meetings, online or face-to-face consultations, and phone calls with a reviewer to have the best outcome. 
  • Get current estimates on project schedules, costs and other management issues related to NMPA projects.

This event is brought to you by the RAPS Boston Chapter to encourage knowledge sharing and community development. RAC holders may claim one RAC recertification credit.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 48 hours prior to the start of the webcast. A live Q&A portion with the speaker will follow the presentation.

Note: Registration will close 48 hours prior to the webcast.

Featured Speaker:
Chang-Hong Whitney, MBA, RAC, president, Whitney Consulting Ltd.