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(영문) 서울서부지방법원 2018.12.18 2018고정830
의료기기법위반
Text

Defendant shall be punished by a fine of KRW 1,000,000.

When the defendant does not pay the above fine, 100,000 won.

Reasons

Criminal facts

On May 23, 2011, the Defendant is a business operator who registered the electronic commerce business with the trade name “D” in Yangju-si C, 109 Dong 202 and sells household goods, etc. in online shopping mall.

1. No one shall, in relation to an advertisement of a medical device, advertise the name, manufacturing method, performance, efficacy, or effect of a medical device different from those permitted or reported pursuant to Article 24 (2) 5 of the Medical Devices Act;

However, from July 21, 2017 to July 24, 2017, the Defendant imported without filing an import declaration in the online shopping mall, such as the 11th price, G market, etc., “Medical Use Ad (Receipt 16-1284, Model Name E): (Receipt 16-1284, “16.05.16, A60.01 (1) and (c) : The purpose of use of the KM C D D D D D D D D D: The Gu used for the protection of organization.”

There is a fact that “the thickness” is short (1.6 m), heat resistant polybes, 20 times re-mixable, U.S. FDA approval, and lives, and that “the hidden letter” was advertised with the flow of the air.

2. In relation to the prohibition of ordinary activities of medical devices, any person shall obtain permission for import pursuant to Article 15 (2) of the Medical Devices Act, and shall not repair, distribute, lease, award, or use any medical device that has not been reported pursuant to Article 26 (1) of the Medical Devices Act, and shall not manufacture, import, repair, store, or display any medical device for the purpose of sale, lease, granting, or use;

However, the Defendant imported the above medical device 1 gambling (25) from a person who visits the United States around July 2017 without filing an import declaration, and was advertised for the purpose of selling it in the online shopping mall, such as 11 hours from July 21, 2017 to July 24, 2017, while the Defendant advertised it for the purpose of selling it in the online shopping mall, such as the 201th day, G market, etc., the Defendant suspended the sales of the medical device without reporting from the Auction Safety Transaction Center and the above medical device importer.

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