January 11th 2018, China Food and Drug Administration (CFDA) issued announcement about Accepting the Medical Device Oversea Clinical Trial Data Technical Guideline. Which means the oversea medical device manufacturer can use their oversea clinical trial data for CFDA medical device registration rather than do the clinical trial in China.
This guideline used for directing the acceptance of the oversea clinical trial data during the CFDA registration application. This guideline came up with the ethical principles, legal principles and scientific principles for accepting oversea clinical trial data. It also specified the document requirements and technical requirements for the oversea clinical trial data.
In this webinar, you will learn about
- Analysis the main content of the regulation regarding medical device clinical trial requirement;
- The basic principle of accepting the medical device oversea clinical trial data
- The requirement for oversea clinical trial data be accepted by CFDA
- Case Study
- Question and Answer
Time and Schedule
Webinar 1 (English)
- Time: 15 May. 2018, Tuesday , PM 5:00-6:00 (GMT+8 China), AM 9:00-10:00 (GMT)
- Presenter: Ms Elaine Lyu, Senior Consultant of Medical Device Legislation Compliance
- Registration fee: Free of charge
About the Presenter
Elaine Lyu| 吕烨
Senior Consultant of Medical Device Legislation Compliance
Ms. Elaine Lyu is a Senior Consultant in the Medical Device Legislation Compliance Department of CIRS Group. She gained her master degree (Advancing Practice) from University of Worcester. Elaine has extensive background in China medical device regulatory activities by developing compliance procedures for medical device registration in CFDA, and she is the most professional consultant in assisting imported medical devices access in Chinese market. Moreover, she focuses on tracking and update of CFDA medical device regulations, share the most relevant newsletter and significant info with the clients.
Who Shall Attend
- Manufacturers and distributors who export medical device or IVDs to China;
- Regulatory affairs specialist - healthcare;
- Quality control professionals
How to Register
Click the link below to register
Please consider your time zone and language.
After online registration, you will receive a link one day and one hour 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) | Beijing CIRS Tech Co. Ltd (CIRS Beijing)
· Mrs. Elaine Lyu, Elaine@cirs-group.com
· Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533