This joint webinar will give an overview of China and Europe medical device regulations, and take surgical masks as an example to demonstrate the registration process of medical devices both in Europe and China.
Time & Schedule:
- Introduction of Chemsafe and CIRS
- General introduction of the Medical device regulation in Europe Q&A
- General introduction of the Medical device regulation in China Q&A
- Case study - regulatory steps to place a surgical face mask on the European market
- Case study - regulatory steps to place a surgical face mask on the Chines market Q&A
Alessandra Iavello, PhD in Medical Physiopathology, is Chemsafe’s Medical Device Business United Head. For several years now she has dedicated herself to consulting services in the medical device field. In addition to drafting the entire technical documentation, her main focuses are feasibility studies and data gap analysis on borderline products, clinical, toxicological, and biological evaluations of devices and monitoring of biocompatibility studies.
Ms. Yolanda YAN, BD Manager, CIRS Group
Ms. Yolanda YAN is the BD Manager of 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, helped many overseas medical equipment products successfully enter the Chinese market.
Click the link below to register
Note: You will receive a link one week and 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.
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Chemical Inspection & Regulation Service (CIRS China)
Addr: 11/F., Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
TEL: +86 571 8720 6559