The medtech industry is one of the key industries in China where the government calls for local R&D and manufacturing so as to reduce the country’s dependence 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 submissions, from processes to approval to modifications of submissions. 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 510(k) and PMA Submission Strategy Workshops, you will walk away with actionable insights and strategies for assembling and streamlining your submissions.
Agenda topics will include:
- The law and regulations
- Strategy and planning
- Clinical trial or evaluation requirement
- Type testing requirement
- CMDE/CFDA review process
- Discussion and experience sharing
- Post-market compliance
Davey Han, M.D., M.S.
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 medical device 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.
Kent D. Kedl
Kent is a Senior Partner in Control Risks Asia Pacific. Based in Shanghai, Kent is responsible for the Compliance, Forensics and Intelligence practice throughout Asia-Pacific. Kent is also the Chairman of Control Risks’ Greater China and North Asia region. He has lived and worked in Asia since the early 1980s.
Kent has consulted with multi-national and local Asian corporations across all industries on a diverse range of complex risk and strategy issues; from M&A and organic growth strategy, to crisis management and operational business controls, to strategic and organizational development programs. Kent has particular experience and expertise in the healthcare, food and beverage, manufacturing and consumer products sectors across Asia-Pacific.
Prior to joining Control Risks, Kent was general manager and co-owner of Technomic Asia, a market strategy consulting firm providing mergers and acquisitions advice, deal structuring and negotiations, market research and strategy planning. His work included target selection, investigations of companies prior to a deal (acquisitions, joint ventures, licensing, franchising, etc.) and deal negotiations.
Kent has a bachelor’s degree in English and a master’s degree in East Asian studies from the University of Minnesota. He also completed graduate studies in journalism and mass communication as a scholar at the China Times Centre for Mass Media and Social Studies.
Amra Racic is a Principal Regulatory Affairs Policy and Advocacy Specialist within the Corporate Regulatory team at Medtronic in Minneapolis, MN. She has been in the Healthcare industry for over 17 years, 9 of those spent with the Medtronic regulatory group doing a variety of US FDA and international submissions for high, medium and low risk medical devices. Additionally, she has been the regulatory liaison during the development of a number of in-vitro diagnostic devices and has understanding of the specific regulations affecting these devices. Prior to Medtronic, she has also worked on regulatory projects at Bayer AG and also had responsibility for patient care management at a local hospital in Minneapolis.
In her current role, Amra has primary responsibilities in the areas of identifying, leading and executing on Medtronic global regulatory advocacy initiatives through venues such as direct advocating with the government officials, training of various levels of regulatory authorities, seminar presentations and development of position and white papers. Likewise, Amra heavily participates in trade association working groups as well as various other harmonization working groups.
Amra is also currently tasked with implementing and establishing regulatory policies across the strategic business units and geographies to ensure that the company has adequate policies to operate in accordance with global requirements. She spends much of her day to day operations tracking and interpreting worldwide new and changing regulations and the effects of those on the individual businesses. She has also led internal teams of experts through various exercises of assuring compliance to a variety of regulatory requirements, including those in China.
Amra holds a B.A in Business Administration and an MBA with focus on Business Management from Walden University.
December 5-6, 2017
PEW Conference Center
901 E Street, NW | Washington, DC
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00
Cancellation and Refund Policy
All cancellations must be received via email to email@example.com (link sends e-mail). Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact us at firstname.lastname@example.org (link sends e-mail) with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.