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1. The Defendant’s KRW 180,881,440 as well as 5% per annum from April 15, 2015 to May 12, 2016 to the Plaintiff.
Reasons
1. Basic facts
A. On April 11, 2013, the Plaintiff, as a medical device dealer, obtained permission for import from the Korea Food and Drug Agency (hereinafter “Korea Food and Drug Agency”) affiliated with the Defendant, for the purpose of “the relaxation of the construction of the mouth” with respect to the medical vibration equipment (No. 13-658, Model KS 1100, hereinafter “instant medical device”).
B. The instant medical device obtained permission for import without undergoing clinical trials on the grounds that it is an essential product that is identical to the licensed product (NURIEY-580, hereinafter “existing Permitted Product”). The existing Permitted Company filed a civil petition with the Ministry of Food and Drug Safety stating that the instant medical device is different from its own product.
C. Accordingly, on September 11, 2013, a public official in charge of the Korea Food and Drug Safety Agency assigned the Plaintiff’s instant medical device on-site inspection, and on October 17, 2013, the Administrator of the Korea Food and Drug Administration issued an administrative disposition (hereinafter “instant disposition”) of the “order for the suspension of sale, recall, etc. of medical device” under Articles 34(1) and 26(2)1 of the Medical Devices Act, on the ground that the actual operating method of the instant medical device differs from that of the permission in terms of automatic circulation, revocation of functions, and change in the order of manual chain.
Then, on March 13, 2014, the Administrator of the Gyeong-gu Office issued a disposition to withdraw the marketing approval of the instant medical device on the ground that “the instant medical device was confirmed in the product not in essence identical to the product already permitted.”
3 15 minutes (A/B action in the order of A/B) 15 minutes of the 15 minutes of the automatic cycle method of the instant medical device in the order of 15 minutes of the 15 minutes of the air pressure frying fry, air pressure frying fry, air pressure frying fry, air pressure frying fry, air pressure frying frying fry, air pressure frying frying frys of the instant medical device.