Medical Devices (includes IVDs)

China NMPA (CFDA) Regulatory and Clinical Affairs Key Updates

Monday, September 14, 2020

10:00 AM – 11:30 AM EDT

Moderator(s)

Grace Fu Palma, MBA

CEO
China Med Device, LLC

Speaker(s)

Jason Liang

QA Director
China Med Device, LLC
Xin Sun

Professor and Director of Clinical Epidemiology and Evidence-based Medicine Research Center
West China Hospital, Sichuan University in Chengdu, China
Jane Lin

Head of Regulatory Affairs, Asia Pacific
Johnson and Johnson Medical
Wei Shang, RAC, CQA

Senior RA Manager
LT

Lindsay Tao, MD

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.

Learning Objectives:

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