China's medical device regulation system started late and has a short development history, but it has developed very rapidly in recent years. In order to provide a better environment for medical devices industry and promote the development of China's medical device industry, many regulations and systems are constantly being revised and updated. Therefore, in response to the rapid changes in Chinese regulations, overseas medical device enterprises need to develop new compliance strategies.
In this webinar, we will discuss the latest changes of China's medical device regulations which involves UDI, MAH, etc. 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.
- Overview of China medical device management
- The latest update of China medical device regulation
- Implementation progress of Medical Device Unique Identification (UDI) in China
- Overview of China Medical Device Registration Electronic Declaration Information System (eRPS)
- Amendments of Medical Device Supervision and Administration Regulations
- Brief Analysis of MAH System of Medical Device industry in China
- Practical advices on how to register a medical product in China
Time and Schedule
Time (Beijing Time, GMT+8)
5th December 2019
17:00 – 18:00
About the Presenter
Ms. Yolanda YAN, Regulatory Affairs Consultant, CIRS Group
Ms. Yolanda YAN is a consultant in 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.
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
· Ms. Yolanda YAN, email@example.com or firstname.lastname@example.org
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533