We are delighted to announce a new series of webinars to keep you updated with the latest regulatory changes in China as the year 2022 progresses. In the Cisema webinar series, our experts also explain the ins and outs of how to register your medical device and IVD in China.
Part 1: New CER requirements for China registration of medical device & IVD
The first webinar of the Cisema Webinar Series 2022 took place on Wednesday, March 2, 2022, addressing the new CER requirements in China. Details as follows:
- Regulatory framework and definitions
- Decision pathway for clinical evaluation of medical device
- Clinical trial decision tree
- NMPA requirements for clinical trial
- CER outline for class I device
- Outline of CER for product exempted from CER
- CER outline for class II & III devices
- CER outline for IVD
- Comparison of new CER guidance (no.73 – 2021) vs. old guidance (no.14 – 2015) and EU MEDDEV 2.7/1(rev 4)
- Feasibility Study
- Case Study
Watch the replay:
Part 2: China NMPA registration of medical device & IVD: Latest updates for clinical pathways
The second webinar of the Cisema Webinar Series 2022 took place on Wednesday, June 1, 2022, addressing the latest updates for clinical pathways in China. Details as follows:
- Classification of Medical Devices and IVDs
- NMPA reporting on 2021 registrations and standards
- Clinical evaluation
- China GCP
- Clinical pathways and clinical trial
- NMPA legal agent
- Sampling inspection for 2022
- Digital health & cyber security
- Localization from regulatory perspective
Watch the replay:
Part 3: China NMPA registration of medical device & IVD: Alternative registration pathways
The third webinar of the Cisema Webinar Series 2022 will take place on Tuesday, September 27, 2022 at 9:30am CET.
Part 4: China NMPA registration of medical device & IVD: Maintaining PMS compliance
The fourth webinar of the Cisema Webinar Series 2022 will take place on Tuesday, December 1, 2022 at 9:30am CET.
Feel free to register here for the webinar series. We encourage you to ask questions in our live webinars. If you are in a different time zone, you can also watch the replay at a time that is more convenient for you.
Contact Cisema if you would like to learn more.