2. The costs of lawsuit are assessed against the plaintiffs.

A. The Plaintiffs are persons engaging in import wholesale and retail trade of medical devices, etc.

B. On January 21, 2015, Plaintiff A asked the Defendant as to the measuring instrument “C”, and Plaintiff B asked the Defendant as to whether each of the measuring instruments “D and E” (hereinafter collectively referred to as “instant measuring instruments”) constituted medical devices, and on January 29, 2015 and March 4, 2016, the Defendant sent to the Plaintiff on January 29, 2015, and to the Plaintiff B on March 4, 2016, respectively.

C. On July 8, 2016, Plaintiff A asked again whether the instant device constitutes a medical device, and on July 25, 2016, the Defendant respondeded to the Plaintiff’s opinion on the examination that “the measurement of a gas oxide among the air gas for patients suspected of suffering from the addiction to the carbon in the U.S. is a medical device, or a non-medical device for the verification of whether it is a mere smoking.”

After that, on April 30, 2019, the Defendant reviewed the reply as to whether the instant product constitutes a medical device, and on May 2, 2019, to the Plaintiff on May 2, 2019, respectively, “the pertinent manufacturer confirmed that the pertinent product was permitted in Europe and U.S. as a medical device including the medical purpose (determination of the addiction to the U.S.), and the determination whether the manufacturer constitutes a medical device should be made on the basis of which the manufacturer manufactured and sold the pertinent product. As such, the pertinent product needs to be determined and notified of the correction of the reply and certification of the medical device (class 2) in order to import and sell the relevant product. Accordingly, the Defendant completed the procedure of certification, etc. under the Medical Devices Act by October 31, 2019, and then imported and sold the relevant product without the medical device certification (permission).”