Boston Chapter: Navigating China’s Medical Device Regulatory Landscape Under NMPA Regulations

RAC Credits
Wednesday, 11 March 2020 (5:30 PM) - Wednesday, 11 March 2020 (8:30 PM) Eastern Time (US & Canada)
One Snyder Drive, Overlook Dining Room
Babson Park, Massachusetts, USA, 02457

Member: $65
Nonmember: $75

China’s medical device regulatory environment has changed dramatically in the last five years. Since China’s National Medical Products Administration (NMPA) issued regulations in 2014 that sought to improve the quality and safety of medical devices, various reforms have been initiated, which continue to change the regulatory landscape. These evolving changes make it challenging to develop regulatory and access strategies to obtain approval and access into the Chinese market.

Come engage with professionals from your local regulatory community for an interactive presentation exploring current NMPA’s best practices and requirements to better manage your 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. This program will consist of a one-hour presentation, followed by a 30-minute Q&A session. Topics to be covered include:

  • How to comply with medical device regulatory requirements under NMPA 
  • Guidelines for successful submissions for obtaining approval and access to the Chinese market 
  • Examine new requirements such as network safety and UDI 

This event is brought to you by the RAPS Boston Chapter to encourage knowledge sharing and community development. Dinner will be available for all participants, and RAC holders may claim two RAC recertification credits.

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