· This webinar will give an overview of medical device clinical trial regulations in China, and discuss the latest changes of China's medical device clinical trial regulations which involves Real World Data, clinical evaluation, List of Medical Devices Exempt from Clinical Trials, and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations. We hope it will help you build an overview of China's regulation and solve your problems.
Time & Schedule:
- Introduction of Clinical Evaluation Pathways
- Introduction of Clinical Trial Process
- Technical Guidelines for Clinical Evaluation of Medical Devices
- Regulations on the Management of Extended Clinical Trials of Medical Devices (for trial implementation)
- Notice on further expanding the scope of implementation of the Simplified Approval Process
- Catalogue of Class III Medical Devices subject to Clinical Trial Approval (revision 200)
- New and Revised Catalog of Medical Devices exempted from clinical trials in 2020 (draft for comments)
- Technical Guidelines for the use of Real World Data in the Clinical Evaluation of Medical Devices (for trial implementation)
Ms. Yolanda YAN, BD Manager, CIRS Group
Ms. Yolanda YAN is the BD Manager of the Medical Device Business Unit of CIRS Group. She Complete her master degree in the IMS major of IMT-BS (Telecom Ecole de Management), France. She specializes in the medical device market and provides professional consulting services of regulation compliance to overseas companies, helped many overseas medical equipment products successfully enter the Chinese market.
Click the link below to register
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Chemical Inspection & Regulation Service (CIRS China)
Addr: 11/F., Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
TEL: +86 571 8720 6559