▲ 의료기기 임상시험 실시기관 지정서 <사진제공=의정부을지대병원>  © 경기북부/강원 브레이크뉴스

[김일중 기자 = 경기북부/강원] 의정부을지대학교병원이 의료기기 임상시험 실시기관으로 지정됐다고 밝혔다.

의정부을지대병원 임상시험심사위원회(IRB)는 규정 및 운영지침 구성, 전문인력과 시설 확보 등 면밀한 준비과정과 엄격한 실태조사를 거쳐 지난 12월 23일 식품의약품안전처로부터 ‘의료기기 임상시험 실시기관 지정서’를 획득했다고 전했다.

임상시험에 사용되는 의료기기의 안전성과 유효성을 증명하기 위해 사람을 대상으로 연구하는 의료기기 임상시험 과정은 연구의 정확성 및 신뢰성을 높이기 위해 식약처장의 지정을 받은 기관에서만 가능하다고 했다.

이문규 교육연구부원장은 ”이번 의료기기 임상시험 실시기관으로 지정됨에 따라, 다양한 진료과에서 의료기기 임상시험을 통한 의학연구를 활성화 할 것“이라고 밝혔다.

Kimgood0612@gmail.com

* 아래는 위 기사를 '구글 번역'으로 번역한 영문 기사의 [전문]이다. 

* Below is the [full text] of an English article translated from the above article as'Google Translate'.

Uijeongbu Eulji University Hospital designated as ‘medical device clinical trial institution’

Available only in institutions designated by the Minister of Food and Drug Safety

[Reporter Il-jung Kim = Northern Gyeonggi/Gangwon] Uijeongbu Eulji University Hospital announced that it has been designated as a clinical trial institution for medical devices.

The Clinical Trial Review Board (IRB) of Uijeongbu Eulji University Hospital received the 'Medical Device Clinical Trial Institution Designation Letter' from the Ministry of Food and Drug Safety on December 23 after careful preparation and strict fact-finding process including establishment of regulations and operating guidelines, securing professional manpower and facilities. said to have obtained '

He said that the medical device clinical trial process, which conducts human research to prove the safety and effectiveness of medical devices used in clinical trials, is only possible at institutions designated by the Minister of Food and Drug Safety to increase the accuracy and reliability of the research.

Mun-gyu Lee, Deputy Director of Education and Research, said, "With this designation as a medical device clinical trial conducting institution, medical research through medical device clinical trials will be revitalized in various departments."

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