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(영문) 수원지방법원 2014.06.12 2013구합14529
의료기기 판매중지 등 명령 처분 등 취소
Text

1. As to the defendant's plaintiff

A. An order to suspend the sale of each medical device listed in the separate sheet No. 1 on September 10, 2013;

Reasons

1. Details of the disposition;

A. On July 2001, the Plaintiff manufactured and sold medical appliances with the permission from the Minister of Food and Drug Safety to manufacture medical appliances under Article 26 of the Pharmaceutical Affairs Act (hereinafter “the instant automatic blood pressure system”). On April 9, 2005, the Plaintiff operated the manufacturing and marketing business of medical appliances with the permission to manufacture medical appliances under Article 6 of the Medical Devices Act and Article 5(2) of the Enforcement Rule of the Medical Devices Act (hereinafter “each of the instant medical appliances” in addition to the instant automatic blood pressure system, by obtaining the permission to manufacture medical appliances under Article 26 of the Pharmaceutical Affairs Act from the Minister of Food and Drug Safety.

B. Based on Article 32 of the Medical Devices Act and Article 33 of the Enforcement Rule of the same Act, the Gwangju Regional Food and Drug Administration collected the instant automatic blood pressure on May 28, 2013 and requested the Korea Testing Laboratory (KTL) to conduct an inspection. The Korea Industrial Technology Laboratory conducted a test from May 28, 2013 to June 26, 2013 according to the test standards set by the Gwangju Regional Food and Drug Safety Agency, and thereafter, on June 26, 2013: 【00 Hgs or less, 30 7 x 10 x 5 x 10 x 10 x 20 x 5 x 10 x 10 x 20 x 5 mp or 4m x 5m x 5m x 5m x 5m x 20 mp

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