1. The plaintiff's claim is dismissed.

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

Details of the disposition

The plaintiff is a company that engages in the business of manufacturing, selling, importing, and exporting medical supplies.

On July 6, 2010, Ilsch Rexroth Co., Ltd. obtained a license for imported items (No. 10-671) with respect to the triggerive response measuring device (the model name: ISO ISO ISO System, manufacturer: Germany, manufacturer: Ined Medizinte nik GmbH; hereinafter referred to as “instant medical device”).

On July 17, 2012, Thai New Daily Co., Ltd.: (a) from Bosch Rexrothn Co., Ltd. on July 17, 2012; and (b) on March 13, 2013, the Plaintiff acquired the permission of import items on the instant medical device from Thai New Daily Co., Ltd. in succession.

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) on the day of the said transfer.

From May 23, 2013 to December 16, 2014, the Plaintiff imported a total of 11 medical devices (hereinafter “instant modified medical device”) different from Germany’s “Inomed Medizinteschnik Gmbh” as indicated in attached Table 1 and images.

(F) On May 12, 2015, the Defendant: (a) was released from 7 parts of the 111 parts imported as above; (b) was requested to test and inspect; (c) the remainder was kept in the Plaintiff’s warehouse; (d) the Defendant discovered the import of the instant modified medical device on May 12, 2015; and (e) on May 15, 2015, the Plaintiff imported and sold the instant modified medical device without obtaining permission for change on the ground that “The instant modified medical device was changed from the instant medical device (No. 10-671); and (e) the Plaintiff imported and sold the instant medical device without obtaining permission for change.”