Corporate Director, Global Health Policy J&J Worldwide GA & Policy
Hundreds of new regulations in the forms of policies, guidelines, standards, and announcements are released continuously as part of the NMPA transformational reform. These updates and changes have impacts not only on new submissions but also product modifications, renewals. UDI and real-world data/evidence (RWD/E) has evolved significantly in 2020 impacting how the devices are sold and approved. In addition, NMPA has taken a more active role and introduced more regulations and provided more detailed requirements on post market surveillance, adverse events reporting, PRER reporting due September 30th, 2020.
The session will provide a review of the latest top NMPA (CFDA) regulatory updates in China Medical and IVD Devices followed by panel discussion on members challenges and solutions.
Understand the key regulatory requirement changes that took place in 2020 and implications
Describe 2020 technical standards update and their implications on product design phase
Discuss UDI implementation updates since its introduction in 2019
Explain real-world data/evidence implementation to mitigate clinical trial requirements (RWD/E)
Discuss post market surveillance updates in AE, Recall, PRER reporting