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(영문) 서울중앙지방법원 2019.03.14 2017가단5079864
손해배상(국)
Text

1. The Defendant’s KRW 93,566,437 as well as 5% per annum from January 1, 2017 to March 14, 2019 to the Plaintiff.

Reasons

1. Facts of recognition;

A. The Plaintiff’s Plaintiff’s manufacture and sales of medical appliances obtained permission from the Commissioner of the Korea Food and Drug Administration to manufacture medical appliances pursuant to Article 26 of the Pharmaceutical Affairs Act with respect to the automatic electronic blood pressure system (B, C; hereinafter “the instant automatic blood pressure system”) around July 2001, and around April 9, 2005, he/she operated the manufacturing business of medical appliances after obtaining permission to manufacture medical appliances from the Commissioner of the Korea Food and Drug Administration pursuant to Article 26 of the same Act with respect to his/her personal high-frequency stimulation (D, E; hereinafter “the instant low-frequency stimulation”; hereinafter “each of the instant medical appliances” in combination with the instant automatic blood pressure system. The Plaintiff operated the manufacturing business of medical appliances after obtaining permission to manufacture medical appliances pursuant to Article 6 of the Medical Devices Act or Article 5(2) of the Enforcement Rule of the same Act.

B. (1) On May 28, 2013, based on Article 32 of the Medical Devices Act and Article 33 of the Enforcement Rule of the same Act, the Korea Food and Drug Safety Agency affiliated with the Defendant collected the instant automatic blood pressure system and requested the Korea Industrial Technology Laboratory (KTL), which is the Intervenor to the Defendant, to conduct an inspection. The Intervenor conducted a test from May 28, 2013 to June 26, 2013 in accordance with the testing standards set by the Gwangju Food and Drug Safety Agency, and failed to meet the requirements of “the accuracy of the Cff pressure mark” on June 26, 2013, for the reason that it does not exceed 【 3mpHg or lower, 100 x or 40 x, 40 x or 85m pressure level or 5m pressure level or 85m pressure level or 5m pressure level or 5m pressure level or 5m pressure level, respectively.”

(2) Based on Article 32 of the Medical Devices Act and Article 33 of the Enforcement Rule of the same Act, the Defendant’s Busan Regional Food and Drug Safety Agency, collected the low-frequency theater and requested the intervenors to conduct the test and inspection on June 10, 2013. The Intervenor from June 10, 2013 to July 8, 2013.

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