All appeals by the Defendants and the Prosecutor are dismissed.

1. Summary of grounds for appeal;

A. In light of the relevant provisions and the functions of Aarker’s change of the part of the Defendants’ (1) mistake of facts, misunderstanding of legal principles (A) and the part of the “Eye Traker’s operation (the model name: J; hereinafter “J”) constituted “a minor change” rather than “a significant change that affects stability and effectiveness,” which constitutes “a minor change,” and is sufficient matters to be reported ex post without obtaining prior permission for change.

(B) If it is necessary to adding to the ICR, CCITRALE rout of each type of ICR, (ICR), re-operation, etc. due to the change of software server in an internal-use semiconductor router operation (a model name: H, hereinafter referred to as “H”), a treatment option added to the treatment option used in the above paragraph (CICRE) but the user is unable to use it and the user purchases it later becomes able to use it with a separate line skiing granted, so the change alone does not require a prior permission of change at the time of import of the relevant medical device.

(2) Each sentence against the Defendants (Defendant A: fine of KRW 30 million; fine of KRW 30 million for Defendant B: fine of KRW 30 million) is too unreasonable.

B. According to the public prosecutor (1) misunderstanding of facts (1) (the part not guilty in the judgment of the court below, including the part not guilty), (a) J-type software (M), etc., the program added the function of changing the thickness and the recovery of the razer in the course of a food operation to the M 3.0 program, and even if the said program was merely a GUI (GU) providing a link to an individual software, it is impossible to use the improved function of the said individual software unless there is M’s business chain. In light of the fact that the GUI’s work log constitutes a change that affects performance and stability, and the program is operated by the defense counsel.