Understanding the Regulatory Framework and Procedure of Medical Device Clinical Trials in China

By the year of 2017, China Food and Drug Administration (CFDA) already issued many medical device clinical trial related regulations, announcements, guideline and etc. This webinar will focus on the regulatory framework and procedure of medical device clinical trials in China.

In this webinar, you will learn about

Enforcement timeline of the clinical trials regulations.
Major Changes of 'Medical Device Supervision and Administration Regulation’ about clinical trial.
Medical Device Clinical Trial Institution Qualification and Filing (Exposure Draft)
How to determine if clinical trials needed for medical device Registration
FAQ about the regulatory framework and procedure of medical device clinical trials in China

Time and Schedule
Webinar (English)

Time: Dec 6th. 2017, Wednesday, 5:00-6:00PM (GMT+8 China), 9:00-10:00AM（GMT)
Presenter: Ms Lou , Regulatory Affairs Consultant
Registration fee: Free of charge

About the Presenter
Lou| 楼晨聪

Regulatory Affairs Consultant
Ms. Lou is a consultant in the Medical Device Legislation Compliance Department of CIRS. She gained her bachelor’s degree of chemistry from Michigan State University in US. She is one of the most professional consultants in assisting imported medical devices access Chinese market. And she also focuses on updating the medical device recording and registration newsletter to our 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

Webinar 1(English):
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.

Contact Us
Hangzhou CIRS Co. Ltd (CIRS China) | Beijing CIRS Tech Co. Ltd (CIRS Beijing)

Ms. Lou，Lou@cirs-group.com
Ms. Elaine Lyu, Elaine@cirs-group.com
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533

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