Medical Devices (includes In Vitro Diagnostics)
Hundreds of new regulations in the forms of policies, guidelines, standards and announcements are released in 2018 and more are expected in 2019. These updates and changes have impacts not only on new submissions but also approved and renewal products. For the first time in China, the piloted MAH system allows the separation of the manufacturing entity from the product design entity for domestically made devices. With the sweeping changes, how can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal as well as to know when to file for modifications to avoid penalties.
The session will help companies intending to enter China and those who have entered China to understand the regulatory strategic factors to consider, the meaning of the new MAH and legal agent, the impacts for local type testing of the 300 technical standards updates being implemented between 2018 and 2020 and CER and clinical data acceptance matrix as part of the new submission.