1. The plaintiff's claim is dismissed.

2. The costs of lawsuit shall be borne by the Plaintiff.

1. Details of the disposition;

A. The Plaintiff is a company that manufactures, sells, and exports and imports medical supplies.

B. On July 6, 2010, Ilsch Rexroth Co., Ltd. obtained permission for imported items (No. 10-671) with respect to the reaction measuring device (the model name: ISO ISO IIOM Compte, Manufacturers: Germany, and manufacturers: Ined Medzinte nik Gmbh; hereinafter “instant medical device”).

On July 17, 2012, Thai New Daily Co., Ltd. acquired permission for import items for each of the above equipment from Bosch Rexroth Co., Ltd. and the Plaintiff acquired permission for each of the above equipment from Thai New Daily Co., Ltd. on March 13, 2013.

On the other hand, the Plaintiff obtained permission from the Defendant to import medical appliances pursuant to Articles 6 and 15 of the Medical Devices Act and Articles 3 and 29 of the former Enforcement Rule of the Medical Devices Act (amended by Ordinance of the Prime Minister No. 1181, Jul. 29, 2015).

C. From March 13, 2013 to May 12, 2015, the Plaintiff imported a total of 11 medical devices (hereinafter “the instant medical device”) from Germany’s Uomed Medizinteschnik Gmbh, as indicated in the separate sheet, and other medical devices (hereinafter “instant change”).

(The 7 parts of the 11st imported as above were released, the 1st test was requested, and the remaining 3 parts were kept in the plaintiff's warehouse).

On May 12, 2015, the Defendant is performing occasional surveillance of medical devices.

On June 18, 2015, the Plaintiff discovered the facts indicated in the claim, and on the ground that “The instant change was made, without obtaining permission for change, on the grounds that “the shape, structure, and raw materials, etc. of the instant medical device (No. 10-671) have been changed from the instant medical device (No. 10-671),” and Article 15(6) and Article 36(1)8 of the Medical Devices Act, and Article 35(1) [Attachment Table 7] of the Enforcement Rule of the same Act are administrative disposition criteria. The relevant item import suspension on the instant medical device (No. 10-671) pursuant to subparagraph 7(c) of the individual standard.