China FDA (NMPA) requires local type testing for the market approval of Class II and Class III medical device/IVD products. China local type testing is a mandatory step for registration and must be completed before the initiation of local clinical studies if needed. Before starting a local type testing in China, you must be ready to answer the questions such as: What tests need to be done in China? Which testing center should I use? What are the Chinese technical standards applicable to my products? When is the best time to plan for the tests? How to write a Product Technical Requirement (PTR)? Do we need to repeat certain tests in China? Do we need type testing for renewal submissions? This webinar will provide you the opportunity to understand the fundamental of Chinese local type testing and find clues to address those questions.
Grace brings 20+ years of industry experience to the medical device industry. She has extensive management experience in marketing, business development, partnerships, and international commercialization from large multinational corporations (Hewlett Packard Medical Products Group, Phillips Healthcare) to start-ups (Teratech Corp). As the founder of the Chinese American Heart Association in 2005, she built the 500-member leading cardiovascular clinicians and scientists’ society with Chinese origins. The combination of cross-cultural mentality and deep Sino-U.S. medtech knowledge and professional experience in China and the United States has enabled CMD to help more than 50 medtech companies with their China entry and growth since its inception. Grace is originally from Beijing, China and graduated with a Bachelor’s degree from Beijing University and an MBA from Yale University.
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