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 on product modifications and renewals. UDI and real-world data/evidence (RWD/E) has evolved significantly in 2020 impacting how the devices are sold and approved. For the first time, a class III implant device was approved in China without the traditional clinical trial, but with a small sample of Real-World Study in a few months. The first batch of devices for UDI will be officially implemented on October 1st. In addition, NMPA has taken a more active role and introduced more regulations and provided more detailed requirements on postmarket surveillance. For the first time, NMPA is requesting PRER report submission with a deadline of September 30th, 2020.

The session will provide a review of the YTD top NMPA (CFDA) regulatory updates in China Medical and IVD Devices followed by the panel experts talking about their top challenges and solutions in the following key areas: Real-world study for regulatory approval, UDI pilot implementation, AI, cybersecurity, IVD, and postmarket.