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* Title标题	Medical device labeling
* Status处理情况	Completed
* Author作者	C*roly	Date申请日期	2021.09.27
* Content内容	Hello, may I know is there exceptions of using Korean on medical device labeling with respect to 의료기기법 제24조(기재 및 광고의 금지 등)? I saw from 의료기기법 시행규칙 제44조(기재사항의 표시방법) 제1항제1호 that, Korean may not be written in the case of writing in a foreign language in the case of permission, certification, or notification of a medical device. Is that mean we can submit our notification request with all our documents in English if we are a foreign company, and we can use English on our medical device label for selling in Korea?
* Purpose申请目的	To enquire about language usage for medical device labeling.

Customized Law Information Reply
Answerer回答者	Admin	Date回答日期	2021.10.28
Contents回答内容	Thank you for your inquiry. Following is the answer to your inquiry from Customized Practical Law Information. Easy-to-find Practical Law Information provides the necessary legal information for the public in an easy way to understand. As Easy-to-find Practical Law Information service is not able to conduct direct legal review or authoritative interpretation of individual cases, we would like to ask for your understanding that it is cautious matter to provide specific answers to your personal inquiries. For the specific information regarding your inquiry, please contact following institutions: Medical Device Policy Division, Ministry of Food and Drug Safety a department in charge of the Medical Device Act (043-719-3761) e-people https://www.epeople.go.kr/petition/pps/pps.npaid Thank you for using our service. We hope to continue to serve you in the future.
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