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(영문) 서울중앙지방법원 2012.11.14 2012고정2291

의료기기법위반등

Text

Defendant shall be punished by a fine of KRW 4,000,000.

If the defendant does not pay the above fine, 50,000 won shall be paid.

Reasons

Punishment of the crime

The Defendant is a doctor who operates the “F Hospital” on the first floor of the Seocho-gu Seoul Metropolitan Government E building, and the representative director of the “G” corporation as a medical device manufacturing business company.

No one shall sell, lease, provide, or use a medical device without an item approval or without filing a item report, or manufacture, import, repair, store, or display a medical device for the purposes of repair, distribution, lease, provision, or use.

1. Violation of the Medical Devices Act;

A. The Defendant, without filing a report on manufacturing items with the Commissioner of the Korea Food and Drug Administration from early 2009 to March 22, 201, manufactured a non-reusable medical fluor, which is a structure installed inside the injection machine form, such as plastics, for the purpose of using it in the above F Hospital or in the cosckeing procedure, and manufacturing a non-reusable medical fluor, which is a structure installed inside the injection machine form.

Accordingly, the defendant manufactured the above product, which is a class 1 medical device for the purpose of use.

B. The Defendant, at the time, at the time, at a place, and at a number of times as indicated in the above paragraph (a), posted a spool containing the so-called “spool” inserted in the patient’s coin, such as the following paragraph (2), and carried out a spologic procedure, which is a method of correcting the spores by inserting the “spores” by inserting the spores by inserting the top of the reusable medical sealing products manufactured as mentioned in the above paragraph (a) at the end of injection, and putting the spores into the spores by inserting the spores and inserting the spores of the spores manufactured as above.

Accordingly, the Defendant used the above product, which is a medical device that did not report manufacturing products.

C. On 2010, the Defendant: (a) ordered 20 members of the I organization, including H, to use the reusable medical sponsor products that he/she manufactured in coconcing treatment; and (b) granted 20 items of the said products free of charge to them, as in the foregoing paragraph (a).

Accordingly, the defendant did not report manufacturing items.

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