RAMED China Medical Device Regulatory Forum

RAMED China Medical Device Regulatory Forum has been successfully organized by Chinese-American BioPharmaeutical Society (CABS) and RAMED at San Francisco Bay Area on July 28, 2018. The aim of the forum is to help the companies and the scientific research institutions in the US to understand the China medical device market characteristics and the CNDA regulatory requirements.  We were honored to have welcomed more than over 60 attendees, and with various backgrounds, including R&D, regulatory affairs, clinical research, marketing, etc. The forum was a real success and has achieved very good response from the audience who attended the forum.

Speakers from RAMED all are very professional in the medical device industry.

Yongheng Chang

Chief Advisor of RAMED

Mr. Yongheng Chang shared the topic of ‘Organizational development for medical devices administration in China’ during the forum and focus on the main changes of responsibilities from CFDA to CNDA, and newly organized SAMR duties.

Ellen Jiang

Founder of RAMED

Ms. Ellen Jiang shared the topic of ‘To be a winner by regulatory solution for innovative medical devices in China’ in the forum, and her topic contents of both how CNDA regulates innovative medical devices and the how applicant strategically designs solutions for the application.

Christine Jiang

Co-founder & Regulatory Affairs Director

Ms. Christine Jiang shared the topic of ‘CNDA requirements update for medical devices pre-market approval’, mainly focusing on the newly published CNDA amendment of medical device regulation, and what industry can benefit from this reform.

Meanwhile, Ms. Ellen Jiang and Ms. Christine Jiang shared the topic of “CNDA acceptance for overseas clinical data”, and helped the understanding of the applicability of clinical data conducted out of China for CNDA registration purpose, and possible options to avoid duplication in clinical trial.

Jane Shen

Senior Consultant of RAMED

Ms. Jane Shen shared the topic of ‘China medical devices market characteristics’ and gave the audience the whole picture of the number of China clinical organizations, classification and their characteristics as a buyer, sales model, tendering policy, etc.

In this way, CABS and RAMED hope to help enterprises and individuals in need and jointly promote the technological transformation and application of medical device products between China and the United States.