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1. A medical device manufactured by the Defendant against the Plaintiff on April 27, 2015, and an individual hot fever (No. 12-1077);
Reasons
1. Details of the disposition;
A. The Plaintiff (former trade name: C&M) is a company that engages in the business of manufacturing medical devices.
On July 8, 2013, the Plaintiff acquired the right to manufacture medical appliances and quality control standards (Godan Pacting Pacting e, hereinafter referred to as “GMP”) from a private temperature machine (hereinafter referred to as “the right to manufacture”) recognized in conformity with the former Medical Devices Act (amended by Act No. 13116, Jan. 28, 2015) pursuant to Article 47(3) of the former Medical Devices Act (amended by Act No. 13116, Aug. 22, 2012) by acquiring the right to manufacture medical appliances (the right to manufacture of the medical appliances in question) from the location of the factory “Yansan-gun, Chungcheongnam-gun, Chungcheongnam-gun (Road Address: 520, YM-300, hereinafter referred to as “the right to manufacture”).
B. On November 18, 2013, the Plaintiff: (a) transferred the location of its head office to 520, the Qusan-gun, Chungcheongnam-gun; and (b) manufactured and sold approximately 1,380 medical devices in this case at the place from around that time to October 2014.
C. On November 6, 2014, the Defendant issued an order to suspend the sale and to recall the instant medical device manufactured between July 8, 2013 and November 6, 2014 on the ground that the instant medical device was manufactured and sold without obtaining the recognition of GMF conformity to the Plaintiff. D.
On January 20, 2015, the Plaintiff received a test for finished products with the recognition of GMF suitability for the instant medical device, and received a test for finished products. On March 13, 2015, the Defendant released an order to suspend the sale of the instant medical device, and notified the Plaintiff on March 30, 2015 that the order to recall was terminated.
E. On December 29, 2014, the Defendant provided the Plaintiff with an opportunity to present his opinion, and on April 27, 2015, the Defendant issued that “the Plaintiff manufactured and sold the instant medical device without obtaining the MFP conformity recognition, did not prepare and keep records on the input and delivery of raw materials, and did not conduct the test and inspection of raw materials finished products.”