Topic: How to increase the likelihood of China CER approval?
Date: Wednesday, Feb 23, 2022, 8:00-9:00 AM Pacific Time (US and Canada)
Clinical evaluation is mandatory for getting market approval in China for Class II or III medical devices unless the device is clinically exempted. With the implementation of Order 739, the newly revised fundamental regulation of medical devices, clinical evaluation can be achieved by different pathways including the clinical evidence from equivalent or comparable devices, clinical trials in China or overseas, or multi-region clinical trials. The preparation of a solid and convincing CER with robust clinical evidence plays a significant role in the regulatory decision-making process. In this webinar, our speaker Dr. Mike Zhu will discuss the basis and rules of developing a China CER, how to select the least burdensome clinical pathway, tips, and pitfalls in preparing a China CER, and finally introduce the differences between China CER vs. EU CER to figure out how much information you could leverage from EU CER (if it exists). Participants will be able to develop strategic thinking when making decisions for the clinical path to support China submissions and more efficiently prepare a convincing China CER.
Agenda:
- Major changes to clinical evaluation under Order 739
- Have you chosen the best clinical pathway to register your products in China?
- How to prepare a convincing China CER?
- How to get your CER accepted for review?
- Good practice as well as pitfalls in preparing a China CER
- Major differences between a China CER and an EU CER
Speaker:
Mike Zhu, PhD
Vice President of Medical/Clinical Affairs, Inspirative Medical
Dr. Zhu has over ten years of experience as a researcher and a regulatory/medical/clinical affairs leader at global leading medical device companies. He has extensive experience in global clinical evaluation, including EU MDD/MDR CER, China CER, TGA CER, etc.
Registration Link
https://zoom.us/webinar/register/WN_klRGM-GPQiKtVj3fBTZ8mw
![[Webinar] UK-China Medical Device Access to China](https://imdmedia.s3.amazonaws.com/2021/09/logobgh2.png "[Webinar] UK-China Medical Device Access to China")
