The U.S. Trade and Development Agency (USTDA) hosted the China FDA (CFDA) Medical Devices Executive Leadership Training program at Yale University and industry meetings in Washington, DC from July 16 to the 29th, 2017
The curriculum for the 21 senior officials featured global best practices on approving imported medical devices. The CFDA delegation met with U.S. companies interested in accessing this China market, medical device industry associations, and U.S. government agencies.
On the 25th of July the delegates spent the day with U.S. industry leaders in Washington, DC. Here are downloads of that day:
Workshop App: Available at both Google Play (direct to app download) Apple Store direct to download
Presentations – In Order of the Agenda:
Morning Session:
Presentation 1: Building a Cooperative Regulatory Environment in China Fostering Innovation
Speaker: Pei Liu, Counsel, Department of Legal Affairs, CFDA
Presentation 2: Medical Devices Clinical Trials Requirements and the Importance of Multi-Regional Clinical Trials
Speaker: Mingdong Zhang, Chief Medical Officer & Vice President of Medical and Regulatory Affairs, Boston Scientific Greater China
Presentation 3: Unique Device Identification (UDI) – Updates on US and Global UDI Activities Including Harmonization and Classification
Speaker: Dennis Black, Director of e-Business, Senior UDI expert, BD
Afternoon Sessions:
Presentation 1: Fostering Medical Device Innovation in China
Speaker: Zhong Lu, Deputy Director General, Center for Medical Device Evaluation, CFDA
Presentation 2: US Medical Devices Innovation – the “21st Century Cures Act” and Streamlined Medical Devices Approval
Speaker: Patricia Shrader, Vice President of Global Regulatory Affairs Medtronic
Presentation 3: What is FDA Pre-Consulting Mechanism and How it Impacts Industry Innovative Product Registration
Speaker: Mary Edwards VP Clinical and Regulatory Affairs, Edwards LifeSciences
Additional: Role of Third Party Test Labs and Certification
Mark Leimbeck, Principle UL Health Sciences’ Risk Management Practice
USTDA sponsored the program in cooperation with
The U.S.-China Health Cooperation Program(HCP)
and the Yale School of Public Health
Additional Sponsors
Delegates
The delegates from China’s FDA include Director level executives from Dept of International Cooperation, Dept. of Registration, Supervision & Evaluation Dept., and many more from CFDA and Affiliated Agencies such as the Medical Device Test Division.
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Contact Information PHM International is organizing this event on behalf of USTDA. For more information please contact Mr. Hank Kearney, President of PHM International at hankk@phmintl.com or +1.772.388.6496 ext. 104. |
Sponsored by U.S. Trade and Development Agency
The U.S. Trade and Development Agency (USTDA) helps companies create U.S. jobs through the export of U.S. goods and services for priority development projects in emerging economies. USTDA links U.S. businesses to export opportunities by funding project planning activities, pilot projects, and reverse trade missions while creating sustainable infrastructure and economic growth in partner countries. |
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* Participation at and/or sponsorship of a USTDA event is limited to U.S. Individuals, U.S. Firms or U.S. Consultants as defined in USTDA’s Nationality Requirements, in addition to invited guests from USTDA eligible countries. For more information, please visit www.ustda.gov.