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Conference Background
CFDA has changed the name as National Medical Products Administration (NMPA) in 2018, and the mother law in China-Regulations of Supervision and Administration of Medical Devices has also been updated in the past year. The regulation and policy of medical device in China was stricter and more crucial. The amount of announcement, notice and policy education documents published by NMPA has came up to 50 in 2018 and the content was covering catalogue updates, registration and approvals, clinical trial, post-market supervision and production & management.
There are a series of challenges and opportunities for medical device manufacturers, suppliers and the whole medical system in the background of regulation changes. How to improve product efficiency and how to accelerate product launch has become the important proposition for them.
Medtec China organizes Chinese Regulation Conference Track every year to provide the latest regulatory information and compliance strategy for manufacturers, which helps them to develop rapidly in the complicated market.
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Main Topics
>Review and outlook: Regulation updates in 2018 and the implications
>Implementation of Separation of Certificate and Licence, the specific measures and key points
>Practice process of Listing Permit Holder System in China
>Understanding and practice of Special Approval Process Program for Innovative Medical Devices
>Interpretation of Clinical Trial Management System Reform of Medical Device
>Supervisory management plan for imported medical device and its influence
>Medical Device Administration Events (MDAE) management and re-evaluation
Who Should Attend?
>Registration, QA&QC, Compliance, Medicine, R&D Department, Project Manager/Director and Managing Director from medical device manufacturers
>Regulation and Research Service Suppliers and Consulting
>Surveillance Organization and Research Institution
*Conference agenda updates according to speaker confirming.
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