Free Webinar: The Latest Updates of Medical Device Regulations in China

Looking back to the year of 2016, there was huge change happened regarding CFDA medical device regulation. It includes the update of GCP, issued the exemption list of clinical trial for medical device, increasing monitor level for clinical trial and quality system etc.
With the regulation to be more stringent, both domestic and oversea medical device manufacture shall be more familiar with the CFDA medical device policy and regulation, in order to promote the medical device compliance with regulation and market as early as possible. Such as CFDA will increase scrutiny for GMP of oversea medical device, this meeting will also give information regarding CFDA oversea GMP verification.

In this webinar, you will learn about

• Summary of CFDA regulation update in 2016;
• Analysis of main update regulation in 2016;
• Analysis of CFDA medical device examine and approve in 2016;
• Summary of medical device adverse event, irregularity, recall condition in 2016;
• Key point of policy and regulation that CFDA will strengthen attention in 2017;
• Information about CFDA oversea GMP verification;
• Suggestion for medical device manufacture to comply with CFDA regulations in 2017.

Time and Schedule

• Time: 26 April. 2017, Wednesday, PM 5:00-6:00(GMT+8 China), AM 9:00-10:00（GMT)
• Presenter: MissElaine Lyu Senior Consultant of Medical Device Legislation Compliance
• Registration fee: Free of charge
• Language: English

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 importedmedical 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

https://cirs.webex.com.cn/cirs-en/onstage/g.php?MTID=ec6aa526b5224b6ba034e9cfbcc9c7d92

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.
System Requirement:
On PC: IE/ Foxfire/ Google Chrome; Windows 2003 or later (You need download the webex extension when first using it.)
On Mobile Service: Free Cisco Webex app from the app store

Contact Us

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

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