China is one of the largest medical device markets for global medical device enterprises. In recent years, many Chinese medical device regulations have been revised, and some regulations will take effect soon. Due to the quick changes and particular requirements of Chinese regulations, overseas medical device enterprises must devise new regulatory compliance strategies to deal with the new regulations in China.
In this webinar, we will give a comprehensive interpretation the medical device regulatory approval process and practical on how an overseas medical device registration and market in China. We hope it can help you build the overview of Chinese regulations and solve your problems.
- Chinese medical device regulation frame
- Registration pathway
- Workflow on medical device filling or registration in China
- How to conduct the clinical evaluation (exemption or clinical trials)
- How a overseas medical device manufacturer to comply with China GMP
- How to comply with the post-market inspection
Time and Schedule
Time (Beijing Time, GMT+8)
Mr. Harold Xie
About the Presenter
Mr. Harold Xie, Regulatory Affairs Consultant, CIRS Group
Mr. Harold Xie is a consultant in the Medical Device Business Unit of CIRS Group. He completed his master degree in the Faculty of Biology, Medicine and Health, The University of Manchester, UK. He has rich experience in healthcare and biotechnology field. In CIRS Group, he works on overseas medical device market and providing regulation compliance and consulting service to overseas enterprises.
Who Shall Attend
• Manufacturers and distributors who wish to enter China medical device/ IVD market;
• Regulatory affairs specialist - Healthcare;
• QA and QC professionals
How to Register
Click the link below to register
Note: You will receive a link one day before the webinar starts. By clicking that link, you shall be able to join our webinar automatically. Please note that space is strictly limited to a maximum of 100 attendees.
Hangzhou REACH Technology Group Co., Ltd. (CIRS Group)
CIRS Group: 11/F., Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
CIRS Beijing: No. 7 West Block, Dacheng Plaza, 28 Xuanwumen Xidajie, Xicheng District, Beijing, China
• Mr. Harold Xie, firstname.lastname@example.org or email@example.com
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533