Online Question & Answer Session:
15 February 2019
In March of 2018, China’s State Council unveiled a draft plan to reshuffle government ministries, with the China Food and Drug Administration (CFDA), along with several other administrations, restructured as the National Market Supervision Administration. While China’s medical device regulatory standards are becoming more harmonized with international standards, the Chinese registration process still poses significant challenges for western device firms.
This virtual presentation will provide a high-level summary of the registration procedure in China, including an overview of each step in the process for registering a device or IVD. And, as China is going through a major reform of its regulations, this presentation will attempt to summarize both the challenges and opportunities that the new regulations will bring.
How does this webcast and virtual Q&A work?
- Step One: Watch the on-demand webcast between now and Thursday, 14 February.
- Step Two: Once you’ve watched the webcast, post your thoughts or questions for the speaker in the online community for this activity. (Instructions will be provided upon registering.)
- Step Three: The Speaker will log-on to the online community on Friday, 15 February to answer questions and respond to inquiries. This is not a live Q&A. All participants will have access to the recording and virtual Q&A session for one year.
This virtual activity was developed by the RAPS New York/New Jersey chapter to help regulatory professionals be more prepared to register products in China.
Lin Lin, regulatory affairs manager, Ortho Clinical Diagnostics
RAPS Members: $20