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Securing Regulatory Approval In China

June 4, 2019 to June 5, 2019
Palo Alto, CA
Global, Regulatory
Workshop

View the agenda here
 

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!

portrait of Davey Han

Davey Han, M.D., M.S.

Dr. Han is the Founder and CEO of BioHan Biotechnology Consulting (Beijing) Co. Ltd., which is dedicated to providing 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 experience from government agency, academies, and medical industry. He worked for the Chinese Academy of Medical Sciences, and National Health Economics Institute of MOH. Then, he entered the 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 the 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 a 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.

 

portrait of Vy Tran

Vy H. Tran, J.D.

Senior Vice President, Regulatory Affairs and Quality Assurance, Varian Medical Systems

Vy H. Tran has been with Varian Medical Systems since 1998. In her current role as the vice president of regulatory affairs and quality assurance, Tran oversees quality systems compliance, quality assurance, internal audits, document control, post market surveillance reporting and quality systems training for all of the company’s manufacturing sites worldwide. She is also responsible for the regulatory clearance and approval strategies to ensure that new products are accessible to a global market in a timely manner. Vy holds a Bachelors of Science from Santa Clara University and a Juris Doctorate from Lincoln Law School of San Jose.

 

portrait of Susan Xue

Susan Xue

Susan works as independent senior regulatory affairs consultant at Biohan, helping client companies explore and achieve business goals in China by providing regulatory strategies and execution guidance. Before that, Susan headed regulatory affairs for all the product lines of St. Jude Medical (now part of Abbott Laboratories) in China. During her 20-plus years of contributions in the company, Susan recruited, trained, and led a strong team of professionals that successfully navigated a complex and changing regulatory environment in China for hundreds of imported medical consumable products and equipment from the United States and European Union. She has deep and extensive regulatory affairs knowledge and experience, including the handling and overseeing of conventional and innovative expedited submissions, type testing, inspections, clinical strategies, panel meetings, physician advisories, and product recalls. Susan is known in the industry for her professionalism and collaborative approach, and has worked effectively with various industry groups, government and regulatory agencies.

Susan is Vice Chair of the China Association for Medical Devices Industry Expert Committee, focusing on the training and exchange of regulatory compliance professionals. She also serves on the China Society for Drug Regulation’s International Exchange and Cooperation Research Committee. Susan earned a Bachelor of Science from the prestigious Ocean University of China and currently resides in both China and Canada.

 

portrait of Zeli Yu

Zeli (Scott) Yu

RAC (Global)

Mr. Zeli Yu, founder of YUZELI MEDTECCONSULTANT Inc., graduated from the Medical College affiliated with Shanghai Jiao Tong University. In his 25-year medical device career, Mr. Yu worked on different positions as Point of Care (POCT) Specialist, Notified Body Auditor and China Healthcare Manager, FDA 3rd Party Reviewer for HP Medical (I-STAT), TUV Product Service, and BSi Product Service respectively.

At present, Mr. Yu, as a RAPS certified senior independent regulatory consultant holds an FDA 510(K) certificate, 21CFR820 and ANSI ISO14971 AAMI certificate, based on his experience with regard to more than 1000 man days of E.U. & U.S. regulatory compliance audits. Mr. Yu has achieved 70 FDA inspections with NAI & VAI and 6 successful 510(K) submissions since 2010 when his consulting business was started. Especially in 2017 in the U.S., Mr. Yu helped manufacturer accomplish the FDA PMA pre-approval inspection for class III device with NAI result.

Besides Global compliance consulting, Mr. Yu also focused on China regulation development and compliance. In 2006, he worked as key third-party translator in the China Device Regulation development program, and since 2017, he was appointed as guest senior expertise tutor by "CHINA FOOD AND DRUG ADMINISTRATION INSTITUTE OF EXECUTIVE DEVELOPMENT" to deliver the Inspection Technique for government inspectors.

So far, Mr. Yu has been 14 times involved in the preparation of the NMPA ( EX CFDA) oversea inspection, and his work covers but is not limited to:

  • Give manufacturer awareness of the Inspection team, coach the accompanying staff QMS knowledge and let them understand the basics of Annex IV in IVD, Annex II in MDD and QSR 820
  • Clarify NMPA regulation and the inspection checklist
  • Set up the front/back room in the manufacturer and clarify the difference between USFDA inspection and the EU Notified Body Audit
  • Support manufacturer project team to do the gap analysis using the NMPA regulation and checklist
  • Perform mock inspection
  • Identify the potential translation candidate from facility staff team and develop translation / interpretation skills for the translator
  • Review & support the preparation of the documentation required by the (SMF) Site Master File from NMPA
  • Help response finding during the post-inspection stage.

 

Varian Medical Systems
3100 Hansen Way
Palo Alto, CA  94304

Registration Fees

AdvaMed Member Registration: $1,595.00 
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00 
Non-Member Registration: $2,095.00