FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

China Releases Checklist to Guide Inspections of Device Trials

Dec. 20, 2018
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China’s National Medical Products Administration released a checklist for sponsors of device trials that places data integrity at the top of the list.

The authority said it developed the checklist in response to recurring problems seen during inspections.

The agency lists red flags that would indicate a problem with data authenticity, such as clinical trial data that is not traceable.

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