Which is your clinical pathway in China, CER or Clinical Trials?
How to get oversea clinical data accepted by China SDA?
How can you use CFDA unapproved device in China in special zones?
Join us for this webinar to have the answer to the question.
Live Webinar with Q&A Session
Given by Grace Fu Palma, CEO of China Med Device.
2PM-3PM U.S. Eastern Time, June 12, 2018
11AM-12PM U.S. Pacific Time, June 12, 2018
Register Now
CFDA clinical requirements for medical device/IVD have been evolving dynamically in the past few years. It is important for foreign manufacturers to understand the China specific clinical requirements, available clinical routes with CFDA registration, and major clinical related regulatory changes. This webinar will cover the following aspects:
- What are the criteria for different clinical routes in China?
- How much does it cost you to run clinical trials in China?
- When should you decide which clinical route to take in China?
- What are the key ingredients for effective clinical trial in China
Our Speaker
A Sino-US medtech veteran, providing U.S. medical devices & IVD co
mpanies with turn key regulatory and commercialization services from market assessment to premarket approval, legal representation, clinical evaluation, clinical trial and post market etc. in China. She has been a speaker at national regulatory meetings as well as column contributor for US regulatory news and journals. With 20+ years of experience driving global product strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies, she has held a variety of management positions in marketing and operations at multinationals and start-ups.
2PM-3PM U.S. Eastern Time, June 12, 2018
11AM-12PM U.S. Pacific Time, June 12, 2018
Register Now
Our Following Webinar Schedule：
How to be Prepared for CFDA Oversea Inspection
New CFDA 3D Printed Medical Device Draft Guideline
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.