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Free Webinar: Regulatory Activities of China Medical Device in 2021

In 2021, China accelerates medical device regulatory reform with new medical device regulations, the new Medical Device Administration Regulations(Decree No. 739) implemented on 1 June 2021, the new Medical Device Registration Rules ( SAMR order No. 47) and In Vitro Diagnostic Reagent Registration Rules (SAMR order No. 48) come into force on 1 October 2021, and the new requirements of medical device registration dossier be implemented from 1 January 2022.

There are 12255 registration applications accepted(for initial registration, renewal , and technical changes) and 11314 registration applications approved by NMPA in 2021, 14.9% more than were approved in 2020. the 6718 of the approved applications were for imported medical devices, showing an 7.6% increase from 2020.

In this webinar, we will summarize the regulation updates and regulatory activities in 2021, to assist the companies keep up with the new regulation updates and know more about how to register the medical device under the new regulations.

In this webinar, you will learn about

  • The overview of medical device regulatory activities in 2021

  • The data analysis of medical device registration in 2021

  • Summary of medical device regulation updates in 2021

  • The new medical device rules in 2022

Time and Schedule

LanguageDateTime (Beijing Time, GMT+8)Speaker
EnglishMarch 17th, Thursday 202217:00-18:00Yolanda YAN

About the Presenter

Ms. Yolanda YAN, Regulatory Affairs Consultant, CIRS Group

Ms. Yolanda YAN is a consultant in the Medical Device Business Unit of CIRS Group. She Complete her master degree in the IMS major of IMT-BS (Telecom Ecole de Management), France. She specializes in the medical device market and provides professional consulting services of regulation compliance to overseas companies.

Who Shall Attend

  • Manufacturers and distributors who wish to enter China medical device/ IVD market;

  • Regulatory affairs specialist - Healthcare;

  • QA and QC professionalsHow to Register

Click the link below to register

https://zoom.us/webinar/register/WN__EvcJMS-RJKWFzBaS_S0HA

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.

System Requirement:

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If you need further assistance about joining the webinar, please click here to Zoom Help Center.

Contact Us

Hangzhou REACH Technology Group Co., Ltd. (CIRS Group)

CIRS Group: 11/F., Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China

CIRS Beijing: No.7 West Block, Dacheng Plaza, 28 Xuanwumen Xidajie, Xicheng District, Beijing, China

Ms. Yolanda YAN, yolanda.yan@cirs-group.com or md@cirs-group.com

Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533