WEBINAR SERIES: REGULATORY AFFAIRS
Cisema Webinar Series on NMPA Registration of Medical Devices in China
Are you a medical device manufacturer interested in the Chinese market but unsure how to overcome regulatory hurdles? In this webinar series, Cisema experts explain the ins and outs of how to register your medical device and IVD in China.
In the first webinar of the series, on March 4, 2021, we were delighted to share a basic understanding of the medical device registration process in China and have an interactive session with our participants.
In our second webinar, on June 8, 2021, our Cisema experts informed you about the latest regulatory changes in China, including Order 739, device lifetime, UDI, MAH system, and real-world data.
In our third webinar, on September 15, 2021, we have addressed the available entry pathways for medical devices and IVDs as an alternative to the NMPA registration in China
If you missed either webinar and are interested in the replay, contact us. Watching the replays will equip you with a basic understanding of the registration process and recent hot topics.
In the final session of this year, our Cisema experts will be informing you about PMS requirements in China. Details as follows:
Thursday, December 2, 2021 - 10:00 CET - PMS, QMS, IVD and other hot topics
• Post-market surveillance: adverse events, recalls and periodic reporting
• Quality management system according to China requirements
• Latest updates for IVD registration
• Medical software and robotics products: Latest updates
• Latest status of Order 739 and implementing regulations and standards
Register now to keep updated on China's fast changing regulatory environment. I encourage you to ask questions in live webinars. Should you be in a different time zone, I invite you to register for the webinar series and watch the replay at a time that is more convenient for you.