1. The Defendant’s medical vibration against the Plaintiff on October 17, 2013 (No. 13-658, model name KS 1100).

1. Details of the disposition;

A. 1) The Plaintiff obtained a license from the Commissioner of the Korea Food and Drug Administration for the import business of medical devices on April 4, 2012, and on April 11, 2013, the Defendant’s medical vibration (No. 13-658, Model KS 1100, hereinafter “instant medical device”).

(2) The instant medical device was granted import permission on the ground that it is an essential product equivalent to the NAYE-5800 of the product already licensed (NURIE-5800) and obtained import permission on the ground that it is an essential product. The method of operating the instant medical device’s functional key for which the Plaintiff obtained import permission is indicated in the column of the terms of permission in the separate sheet

B. As a result of the on-site inspection conducted by the Defendant on September 11, 2013 with respect to the Plaintiff Company, the actual operating method of the instant medical device key was different from the details permitted in the automatic cycle method, revocation of functions, and change of the order of manual bom, as indicated in the right side column of the attached table.

C. On October 17, 2013, the Defendant issued an order to suspend sales, recall, etc., and to publish the fact of recall pursuant to Article 34 of the Medical Devices Act (hereinafter “instant disposition”) on the ground that the instant medical device falls under Article 26(2)1 of the same Act, and notified the Plaintiff of the fact that he/she would bring an objection to the instant disposition within three days from the date of receipt of the order.

[Reasons for Recognition] Facts without dispute, Gap's 2, 4, 5 evidence, Eul's 1 to 3 (including branch numbers), the purport of the whole pleadings

2. Whether the instant disposition is lawful

A. The Plaintiff’s assertion 1) While rendering the instant disposition, the Defendant did not specifically state the facts constituting the grounds for the disposition and the reasons for the disposition. On October 17, 2013, the Defendant did not grant a considerable period of time necessary to submit an objection by October 19, 2013, on the ground that the instant disposition was notified. (2) On April 11, 2013, the Plaintiff obtained an appropriate decision from the Defendant and obtained an import license, and trusted the instant disposition.