Free Webinar: Class I Medical Devices Filing and Approval in China

Over one year has passed since the implementation of new CFDA regulations on medical device, more and more class I medical devices successfully had been approved and sold in Chinese market. The submission and approval procedure is simplified under new regulations. This webinar will focus on how to apply for and obtain the record-keeping for class I medical devices under new CFDA regulations.
If you are a manufacturer or distributor involved in exporting medical device or IVDs to China, this webinar will provide you with necessary briefing on class I medical devices filing guidelines and case study, professional suggestions/opinion will also be given for your reference, based on our practical experiences.

Topics Covered

A summary of latest updates of class I medical device approval and regulation
An introduction to class I medical device management policies in China
Scope and classification of class I medical devices
Submission and approval process for class I medical devices
Practical advice on how to record the class I medical device in China
The potential cost and duration for class I medical device filing
Case study

Time and Schedule

Time: 28 April 2016, Thursday, AM 9:00-10:00（GMT),PM 5 :00-6:00(GMT+8)
Presentation Focus: CFDA regulations, Class I medical devices filing guideline, case study on class I medical device and IVD recorded in China.
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, 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
Registration URL:
https://attendee.gotowebinar.com/register/791897234926209028
Webinar ID: 146-522-779

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. Elaine Lyu, Elaine@cirs-group.com
Mr. Michael Petersen, Michael@cirs-group.com
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533

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