1. The plaintiff's claim is dismissed.

2. The costs of lawsuit shall be borne by the Plaintiff.

1. Details of the disposition;

A. On March 8, 2016, the Plaintiff: (a) completed business registration with the trade name of B; (b) obtained a medical device import business license from the Defendant; and (c) imported 11,000 products manufactured in the United Kingdom without obtaining permission for import from November 8, 2015 to May 16, 2016; and (d) sold 7,500 of them in Korea.

B. On October 20, 2016, the Defendant: (a) imported and sold 7,50 products of this case, which are medical devices, from November 8, 2015 to May 16, 2016 without obtaining permission (certification) for the Plaintiff; and (b) violated Article 26(1) of the Medical Devices Act by selling and selling 7,50 products of this case, which are medical devices; and (c) issued an order for recovery and announcement of the fact of recovery of medical devices under Article 34(1)1 of the Medical Devices Act; and (d) “instant disposition” is deemed as the “instant disposition

A. [In the absence of a dispute over the basis of recognition, entry in Gap evidence Nos. 1, 4, 8, Eul evidence Nos. 2 and 3, and the purport of the whole pleadings.]

2. Whether the instant disposition is lawful

A. The plaintiff's assertion purport that the defendant issued the disposition of this case on the ground that "the product of this case has caused or is likely to cause harm to national health, and may cause temporary or medical side effects, or cause such side effects, which can completely recover from the use of the product of this case." However, since the product of this case was developed around 1995 and is sold to the world, and there is no timely report on side effects from its use, it cannot be deemed that the product of this case has caused or is likely to cause harm or side effects as claimed by the defendant.

Therefore, the instant product does not constitute a medical device subject to an order for recall and a notification of the fact of recall, and thus, the instant disposition was unlawful as it was conducted without any grounds for disposition.

(b) Entry in the attached statutes of the relevant statutes;

(c) judgment 1.