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Steps towards approval application of medical devices

In order to submit approval application of a medical device, the application category (me-too, improved, or new) of the medical device should be determined. If the medical device is categorized as a me-too or improved medical device, tests for product specifications, performance, and biological and electrical safety should be performed prior to approval application. If the medical device is categorized as a new medical device, those non-clinical tests shall be performed to adequately confirm its safety prior to a clinical trial in which safety and efficacy for humans are confirmed, then, approval application is submitted.