Do medical devices need to undergo clinical trials before being marketed?
Release time:
2024-08-30
Clinical trials of medical devices are divided into
Clinical trials of medical devices are divided into clinical trials of medical devices and clinical validation of medical devices.
For medical devices that have not yet appeared on the market and whose safety and effectiveness need to be confirmed, clinical trial studies of medical devices are required before approval for market launch.
For medical devices of the same type that have already been launched and require further confirmation of their safety and effectiveness, clinical validation studies must be conducted before approval for market launch.
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