Free Webinar! CFDA New Notification about Standardize the Use of Chinese Name for Foreign Medical Device CFDA Registration - Regulatory News - Medical Devices

Based on the increasing amount of imported medical devices, CFDA keep strengthening the supervision of medical devices. On August 8^th 2017, China Food and Drug Administration (CFDA) issued an exposure draft about “The Applicant Name, Address and Manufacturing Site for Imported Medical Device Registration and Filing Should be in Chinese” (CFDA Notice No. 43 2017). According to the exposure draft, any imported medical device registration should change the company names, address and manufacturing sites into Chinese before Dec.31^st 2018 and the initial imported medical device registration is required to submit the Chinese information from Jan. 1^st 2018.
This webinar will focus on the interpretation of CFDA new notification about standardize the use of Chinese name for the foreign medical device CFDA registration.

In this webinar, you will learn about

Enforcement Timeline of the new rules
Medical device naming requirements based on normalization and consistency
How to standardize the medical device Chinese specifications and labels compiling
Foreign medical device applicant Chinese name alteration procedure and application dossiers requirements( For the registered items alteration)
Chinese legal representatives alteration procedure and application dossiers requirements( For the registered items alteration)
Imported class I medical devices filing procedures and application dossiers requirements
FAQ about the use of Chinese name for the foreign medical device CFDA registration

Time and Schedule
Webinar (English)

Time: September 6th 2017, Wednesday, 13:00-14:00 (GMT) = 21:00-22:00 (GMT+8) = 9:00-10:00 AM (GMT-5)
Presenter: Ms Lou , Regulatory Affairs Consultant
Registration fee: Free of charge

About the Presenter

Lou| 樓晨聰

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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