Free Webinar: Regulatory Activities of China Medical Device in 2022

In 2022, China continued the pace of the previous year's medical device regulatory reform, with the release of the new version of the “Good Clinical Practice of Medical Device” (GCP) and the “Medical Device Registration Quality Management System Verification Guide”, meanwhile, 40 national standards, 114 industry standards and 4 modification lists for medical device industry standards have been published.

There are 10571 registration applications accepted(for initial registration, renewal , and technical changes) and 11942 registration applications approved by NMPA in 2022, a decrease of 13.7 percent and an increase of 5.5 percent compared with 2021, respectively. the 6250 of the approved applications were for imported medical devices, showing an 7 percent decrease from 2021.

In this webinar, we will summarize the regulation updates and regulatory activities in 2022, 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 2022

• The data analysis of medical device registration in 2022

• Summary of medical device regulation updates in 2022

• The new medical device rules in 2023

Time and Schedule

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

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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

CIRS Shanghai: Room 1203, Lekai Building, No. 660 Shangcheng Road, Pudong New Area, Shanghai, China

Ms. Yolanda YAN, yolanda.yan@jianzaoshiwang.cn or md@jianzaoshiwang.cn

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