Recently, China medical device regulation has undergone several big changes and China regulatory authority is restructuring. It is a new beginning of medical device in China, the CFDA medical device supervision and regulatory framework will be adjusted again in the following years. The policies on registration license holder, China UDI, classification, test, clinical trials, quality management system and approval procedure would experience significant changes in the future. How to obtain the China medical device regulatory approval successfully with low-risk under the new regulations would be a challenge for overseas enterprises.
In this webinar we will talk about the impacts of the latest China medical device regulations change, practical advices for overseas medical device companies to obtain the CFDA approval, and how to access Chinese market under new regulations.
The latest China medical device regulatory changes and how to register the medical device under the new regulations in China:
- The Amendment of medical device management policies in China
- The latest changes of China medical device regulations
- Data analysis of medical device registration
- New requirements and regulations of medical device registration
- The new catalogue of medical device classification
- Practical tips on CFDA registration under the new regulations
Time and Schedule
Time (Beijing Time, GMT+8)
26 September 2018
Miss Shuo Wang
About the Presenter
Ms. Shuo Wang, Medical Device Specialist, CIRS GROUP
Ms. Shuo Wang completed her master degree in the biology program of Leiden University. She has extensive background in life science industry, after joining CIRS GROUP, she focuses on the medical device market and providing professional medical device regulatory compliance support for oversea corporations.
Who Shall Attend
· Manufacturers and distributors who wish to enter China medical device/ IVD market;
· Regulatory affairs specialist - Healthcare;
· Quality control 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)
Addr: 11/F., Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
· Ms. Shuo Wang, Wangshuo@cirs-group.com
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533