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1. On May 19, 2014, the Defendant’s raw materials for the tissue recovery of imported medical devices (No. 10-1267) with the Plaintiff on the part of the Plaintiff.
Reasons
1. Details of the disposition;
A. On November 24, 2010, the Plaintiff, a company engaged in the import and distribution of medical devices, obtained from the Minister of Food and Drug Safety with respect to the deep spectrum (Perthp, No. 10-1266, Nov. 24, 2010; hereinafter referred to as “first medical device”) and the chronum (Perthler, No. 10-1267, Nov. 24, 201; hereinafter referred to as “second medical device”) 2ml (Perfctha Subin) of Subin on November 24, 201; hereinafter referred to as “the 3 medical device”) and the chreblin’s license number 11-1381; hereinafter referred to as “the 13 medical device”); and 3ml (131-14, 134, 2013” respectively.
B. On October 11, 2012, the Minister of Food and Drug Safety determined 197 items, including medical devices, as items subject to re-evaluation of medical devices in 2013 and publicly announced the re-evaluation period through the homepage of the Ministry of Food and Drug Safety, setting the period from October 10, 2013 to December 31, 2013.
C. On August 13, 2013, the Plaintiff obtained respectively permission for import from the Minister of Food and Drug Safety with respect to 1ml (Pertha Subin No. 11-1381, hereinafter “5 medical device”) of the spectrum (Pertha Common Management, License No. 10-1267, hereinafter “6 medical device”) on August 22, 2013.
The Defendant is delegated by the Minister of Food and Drug Safety with authority pursuant to Article 44 of the Medical Devices Act (hereinafter referred to as the “Act”) and Article 13(1)19 of the Enforcement Decree of the Medical Devices Act, and on May 19, 2014, on the ground that “the Plaintiff did not undergo re-evaluation due to the Plaintiff’s failure to file an application for re-evaluation within the application period,” Article 36(1)6 of the Act and Article 35(1) [Attachment 7] of the Enforcement Rule of the Medical Devices Act
Ⅱ In accordance with subparagraph 6(a), the term “the instant medical device” in total, among the medical devices under Articles 1 through 6(a).