CFDA Medical Device Pre and Post Market Overview
CFDA Medical Device Pre and Post Market Overview
Grace Fu Palma CEO
China Med Device, LLC Ph: 978-390-4453 (US)
Ph: 18201749732 (China) Email: gpalma@
Wechat: gracefumed
3/29/2017
info@ ? 2017 CMD
1
Agenda
? China Geopolitical Structure & Importance ? CFDA Major Changes ? CFDA Premarket Approval Overview ? CFDA Post Market
? High Level Comparison ? Onsite Inspection ? Reality
?
3/29/2017
info@ ? 2017 CMD 2
China Med Device LLC
Accelerator of U.S. medtech companies commercialization to China
? Regulatory Services
? CFDA Strategy & Registration ? CFDA Clinical Evaluation Report and Clinical Study ? QMS training and consulting
? Business Services
? Distribution Qualification and Management ? Marketing Development in Partnership and Strategic Funding
3/29/2017
info@ ? 2017 CMD 3
CENTRALIZED HISTORY
3/29/2017
info@ ? 2017 CMD 4
63/1259/20167
info@ ? 2017 CMD 5
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