The medtech industry is one of the key industries in China, where the market demands for high value medical devices have been increasing. The government constantly adjust the regulatory requirements and process to encourage local R&D and manufacturing so as to reduce the country’s dependence heavily on imported high value medical equipment and products. Multinational companies have been adopting new regulatory strategies and exploring new business models in response to this policy and the evolving healthcare reform in China. In the meantime, they are constantly challenged by the regulatory constraints, policy changes and government enforcements in different subject areas.
This course will cover CMDE/CFDA's perspective on regulatory requirements and process for different types of submissions (initial application, registration change and renewal), as well as post market compliance. In this program, industry experts will provide an in-depth guide to how you as an organization can secure regulatory approval in the China market.
Closely paralleling the topics covered during AdvaMed's upcoming 510(k) and PMA Submission Strategy Workshops, the China Workshop 2019 will include a lot of development and updates based on the topics of the workshop 2018. You will walk away with actionable insights and strategies for assembling and streamlining your submissions for the largest emerging market in the world.
Agenda topics will include:
- The law & regulations and government restructure
- Strategy and planning, adopting new regulatory changes
- Submission with foreign clinical trial data without in-China trial
- Type testing requirement and reform
- CMDE/CFDA review process
- Discussion and experience sharing
- Special process to expedite pre-market approval
- Post-market compliance
- And more!
Davey Han, M.D., M.S.
Dr. Han is the Founder and CEO of BioHan Biotechnology Consulting (Beijing) Co. Ltd., which is dedicated to provide the services in medical device and IVDs for CFDA submission, pre-market clinical evaluation, quality compliance, as well as government policy & market research. Dr. Han has broad experiences from government agency, academies and medical industry. He worked for Chinese Academy of Medical Sciences, and National Health Economics Institute of MOH. Then, he entered into global high-tech medical device industry including St Jude Medical and Siemens Healthcare, with various key positions including regulatory affair manager, Asian-regional senior manager, general manager of quality & regulatory affairs, and director for government & key customer relations. From 2010 to 2013, Dr. Han joined the world largest healthcare market research consulting firm -IMS, leading the IMS China Institute. Dr. Han is very active in communication and exchanges between device industry and government authorities. When employed by industry companies, he took many social roles respectively, including Chair, Medical Device Forum of American Chamber of Commerce in China; Co-Chair, Health Equipment Working Group of European Chamber of Commerce in China; Chair of COCIR in China, Vice Chair of Asian Harmonization Working Party (AHWP) in medicaldevice regulations and standards, and China Director of Medical Imaging and Technical Alliance (MITA, a NEMA division). Dr. Han graduated from Tongji Medical University in 1984. From 1993 -1997, he studied at the University of Minnesota and earned the Master of Science in Health Services Research and Policy, and also completed his post-doctorate program in Epidemiology and Clinical Research at the same university.
Varian Medical Systems
3100 Hansen Way
Palo Alto, CA 94304
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00