Candidates for the MFDS approval of the conduct of a trial and its process

• Any medical device trials that will be conducted to collect the data about the safety and efficacy in human subjects
• Any medical device trials that will be conducted for other purposes than obtaining an approval of the use of those which are commercially available on the market (the purpose of use, efficacy / effect and the methods of use)

Non-candidates for the MFDS approval of the conduct of a trial and its process

• Any clinical studies (medical devive trials) that will be conducted to simply collect the data for the purpose of confirming the treatment effect after the patient treatment physicians in the scope of product approval