There was frequent update of Chinese medical device policy and regulations during 2017 to 2018 and lot of new policy and principles were launched by CFDA and CMDE. Multiple areas were covering from aspects of approval speed up, encourage innovation, registration improvement, clinical management and technology increase.
There are a series of challenges and opportunities for medical device manufacturers, suppliers and the whole medical system in the background of regulation changes. How to response the updates quickly, how to improve product efficiency and how to speed up the R&D and market transformation has become the important proposition for them.
Medtec organizes Chinese Regulation Conference Track every year to provide the latest regulatory information and compliance strategy for manufacturers, and to help them develop in complicated market.
>How to improve Quality through unanounced inspection
>The contents and requirements of database in UDI
>Perspective of final user: Medical Device Registration and Listing
>The interpretation and implementation of the medical device registration system
>Key points for the implementation of clinical trial quality management of medical device in China
>Regulation challenges and risks for company when actualize UDI
>Clinical trial design of medical device complying with the updated regulation
Who Should Attend?
>Registration, QA&QC, Compliance, Medicine, R&D Department, Project Manager/Director and Managing Director from medical device manufacturers
>Regulation and Research Service Suppliers and Consulting
>Surveillance Organization and Research Institution
*Conference agenda updates according to speaker confirming.