2018 Annual Report on China Medical Device Regulatory

2018 has been an important year for China medical device market, the China medical device regulation has undergone several big changes and China Food and Drug Administration (CFDA) has restructured as National Medical Products Administration (NMPA). With multiple regulation coming out, medical device corporates are facing a big challenge to bring up the right and quick response to keep/enter the China market steadily during the transition period.  
In this webinar we will give a comprehensive report on new medical device regulations in 2018, practical advices for corporates to adapt to new regulation and possible policy trend in 2019.

Topic Covered  

- Summary of new medical device regulations in 2018
- Implementation of China medical device marketing authorization holders (MAH)
- New medical device classification catalogue and clinical trial exempt catalogue
- Practical tips on China medical device compliance under the new regulations
- Prospect of China medical device supervision trends in 2019

Time and Schedule



Time (Beijing Time, GMT+8)



21 January 2019


Miss Shuo Wang

Registration Fee 


About the Presenter

Ms. Shuo Wang, Medical Device Specialist, CIRS GROUP
Ms. Shuo Wang completed her master degree in the biology program of Leiden University. She has extensive background in life science industry, after joining CIRS GROUP, she focuses on the medical device market and providing professional medical device regulatory compliance support for oversea corporations. 

Who Shall Attend

Manufacturers and distributors who wish to enter China medical device/ IVD market;
Regulatory affairs specialist - Healthcare;
QA and QC professionals

How to Register

Click the link below to register

Note: You will receive a link one day 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, China
Hangzhou REACH Technology Group Co., Ltd. (CIRS Group)
Addr: 11/F., Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
Ms. Shuo Wang,  Wangshuo@cirs-group.com
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533 

Contact Us
CIRS China

Mr. Harold Xie (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801 
Email: md@cirs-group.com