1. Medical device (medical vibration, product license number: B, model name: C) that the Defendant had against the Plaintiff on March 13, 2014.

1. Details of the disposition;

A. The Plaintiff is a juristic person engaged in wholesale and retail business and trade business of pharmaceutical products, medical supplies, medical appliances, etc. in Bupyeong-gu, Busan Metropolitan City D.

B. On April 11, 2013, the Plaintiff obtained marketing approval (approval number : B) from the Defendant on imported medical devices (name A-E, name of medical vibration, model name C: hereinafter “instant medical device”) equivalent to F’s medical vibration (G, model name: H): and imported and sold the instant medical device.

C. On October 17, 2013, the Defendant issued an order to the Plaintiff to suspend selling, recall, etc. the instant medical device pursuant to Article 34 of the former Medical Devices Act (amended by Act No. 12392, Jan. 28, 2014; hereinafter “Medical Devices”) and to publish the fact of recall (hereinafter “order to suspend selling, etc.”) on the ground that the Plaintiff violated Article 26(2)1 of the said Act, and filed a lawsuit seeking revocation of the said disposition on October 28, 2013.

(U.S. District Court 2013Guhap9688), d.

On March 13, 2014, the Defendant issued a disposition to revoke the import license (hereinafter “instant disposition”) on the ground that “the instant medical device was confirmed in the product not in essence identical to the product already permitted.”

[Ground of recognition] Facts without dispute, Gap evidence Nos. 1 through 6, Eul evidence No. 5, the purport of the whole pleadings

2. Whether the instant disposition is lawful

A. The Plaintiff’s assertion 1) The Defendant violated Articles 21 and 23 of the Administrative Procedures Act by not expressly stating the facts causing the disposition in the instant disposition to the Plaintiff, the grounds for the disposition, and the legal grounds for the disposition. 2) The substantive illegal medical devices Article 36 of the Medical Devices Act provides for the grounds for revocation of the permission, etc., and the permitted product is the already permitted product.