Your Way Into China Medical Devices Market

With the reform and advancement of China’s medical device regulation and most recently as Xu Jinghe, deputy commissioner of China’s National Medical Products Administration (NMPA), was elected chairman of the 27th Global Harmonization Working Party (GHWP).

This is a great significance in the process of China’s internationalization of medical device regulation and the demonstration of China’s well-organized medical device regulatory system and effective regulatory work are widely and highly recognized by the international community.

Qmed Consulting & CCRC Medtech team up to present a live webinar “Your Way into China Medical Devices Market”.

This webinar will focus on the latest NMPA regulations for Medical Devices, Drug-Device Combination Products, and IVD, exploring the unique requirements, processes, and approval criteria.  Experts from CCRC will provide a systematic review of all elements in the Chinese regulatory pathways. Furthermore, the overseas clinical trial data pathway is one of the clinical pathways and can be used as a local Chinese clinical trial alternative in NMPA device registrations. The best practice of leveraging the clinical trial data generated outside of China for NMPA registration will be discussed.

Speakers welcome and encourage questions and live discussions. Please submit your questions at the registration form or simply ask questions live during the webinar.

Learning Objectives

– Understanding the NMPA’s regulations, processes, and requirements for Medical Device registration.

– Identify key factors that would affect regulatory strategies and prepare for necessary adjustments.

– What to consider leveraging the overseas clinical trial data for NMPA registration?

– Key aspects to consider during your preparation.

– Gain up-to-date knowledge of current requirements and practices.

Agenda:

  5 mins     –    Opening Remarks –  Helene Quie & Julia Yuan 

  10 mins    –    CCRC MedTech CRO Introduction – Shawn Ho

  30 mins   –   How to find a proper pathway to gain China registration for innovative imported devices? – Sophie Zhang

  30 mins    –  How to leverage overseas clinical trial data to register your devices in China? – Yanfang Song

  20 mins    –  Open discussion 

Speakers:

Helene Quie

Founder and CCO at Qmed

Julia Yuan

General Manager at CCRC

Shawn Ho

Sr. Director, Strategic Development at CCRC

Sophie Zhang

Sophie Zhang is the Head of Regulatory Affair at CCRC Medtech. She has provided technical leadership and expert scientific judgment to review a wide array of medical devices, especially implantable and interventional cardiology & neurology devices.  In addition to the broad spectrum of standard regulatory decisions involved in the China NMPA approval process, Sophie oversaw the review of multiple complex Innovative Medical Device Applications.

Yanfang Song

Yanfang Song is the Head of Medical Affair at CCRC Medtech. She brings more than 10 years of clinical research experience, participated in 100+ clinical research projects, mainly for cardiovascular and neurovascular, orthopedics, radiology, oncology, medical aesthetics, neurosurgery, gastroenterology, and other medical devices clinical trials, clinical evaluation reports, overseas clinical trial data evaluation reports, as well as IVD clinical trials/clinical evaluation.

Sign-up here for the event and contact us at info@qmed-consulting.com for more information: