First Approval Of ENT Active Implant In China With Hainan Real World Data
NMPA first approved the ENT active implants in June and July, 2022 with a clinical evaluation report (CER) integrated of Hainan real world data used to support the equivalence justification and provide safety and effectiveness outcomes in Chinese population. BradyKnows provides the turnkey regulatory and clinical solutions to such two successful cases. It follows Hainan urgent use policy to collect real world data integrated into clinical evaluation report (CER) for NMPA approval.
Till now, BradyKnows is the only consulting company who has helped its client to obtain China NMPA approval from the Hainan Urgent Use Program in the Lechent Medical Pilot Zone. Brady walked together with our client from product landing, real world study, clinical evaluation, and NMPA registration until approval. Brady also supports the post-market surveillance, distribution, and providing regulatory input during the product development.
NMPA has approved five Class III imported medical devices with RWD, and two of them are BradyKnows cases.
In order to help more clients with the least burdensome solution to China, BradyKnows elite team would like to share the experiences for such successful cases as below:
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China strategy map-out and refreshing，
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Type testing onsite support
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Fixture preparation
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Hospital MR safety test
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Clinical evaluation report (CER) writing
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Surgeon training
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Least burdensome clinical solution assessment
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Real world data collection plan and protocol
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RWD application pilot program (Fast Track pathway in China)
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Expert panel meeting
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Patient follow up
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3rd party testing and report assessment
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Registration dossiers preparation
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Mock-up review on registration dossiers
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Handling NMPA queries on reviewer meetings
