The first thing would be to check "whether a similar product is available in the Korea market” and “whether the medical procedure in which the medical device is used has been implemented in Korean hospitals”.
If substantial equivalency is not demonstrated, a more thorough review is required, including a review of the human clinical trial report generated with the product. The number of subjects must be determined through statistical calculation based on the study design, and the safety and efficacy must be substantiated by the statistical design as outlined in the study protocol.
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