1. The plaintiff's claim is dismissed.

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

1. Details of the disposition;

A. The Plaintiff is a company that manufactures and sells medical appliances and appliances.

B. On November 1, 2002, Company B reported to the Defendant the manufacture of a medical device with CroD (UUE et al.) as a product manufactured. On April 28, 2014, the Plaintiff acquired the above report from Company B, and the model name based on the above report was added to E and 15 items.

(hereinafter “instant medical device”). C.

As long as foreign substances were discovered in the instant medical device from hospital of the National Health Insurance Corporation, the Ministry of Food and Drug Safety reported the case four times from April 30, 2018 to June 25, 2018, respectively, and requested the Defendant to take follow-up measures therefor, and the Defendant ordered the Plaintiff to take corrective measures.

On October 25, 2018, the Ministry of Food and Drug Safety reported cases to the extent that foreign substances were discovered in the instant medical device from the Busan University Hospital, and requested the Defendant to take follow-up measures. On November 30, 2018, the Defendant conducted on-site inspections on the Plaintiff’s workplace.

E. On December 5, 2018, the Defendant issued an order to the Plaintiff on the ground that the instant medical device was shipped out without verifying that it was destroyed even though it was destroyed by the germs products (hereinafter “instant disposition”) and on the grounds that the instant medical device was destroyed, such as the publication of the suspension of sales, recall, and recall (hereinafter “instant disposition”).

(a) Article 34 of the Medical Devices Act;

(b) Guidelines for handling medical devices, such as recall and discarding;

2. After importing and selling from ear companies, orders such as suspension of sale, collection and collection, announcement of correction, and preventive measures pursuant to Article 34(1) of the Medical Devices Act shall be taken immediately, referring to the guidelines for recovery and destruction of attached medical devices, and the implementation of such orders and necessary measures shall be taken, and the results shall be submitted to our Cheongbu (the Medical Device Safety Management Department).