의료기기 이야기

In its August 22 webinar, the U.S. Food and Drug Administration (FDA) discussed the Stage 1 requirements imposed on laboratory-developed test (LDT) manufacturers.U.S. FDA Final Rule on LDTsLDTs are in vitro diagnostic devices (IVDs) that are designed, manufactured and used within a single clinical laboratory and were placed under enforcement discretion in 1976 with the medical device amendments ..

We at Emergo by UL would like to point out that the U.S. Food and Drug Administration (FDA) has recently adapted certain searches and information to highlight regulatory guidance for specific medical device types. Medical device and IVD manufacturers who want to stay ahead of regulatory changes to avoid market access disruptions should take note.  Searching FDA guidance documentsThe U.S. FDA  ha..

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devic..

식품의약품안전평가원 체외진단기기과에서 2024년 제6차 체외진단의료기기 허가심사 온라인 민원설명회 발표자료를 개제하였다.  민원인 안내서 > 민원설명회 자료 > 2024년 제6차 체외진단의료기기 허가심사 온라인 민원설명회 | 식품의약품안전평가원 (nifds.go.kr) 민원설명회 자료 > 2024년 제6차 체외진단의료기기 허가심사 온라인 민원설명회 |" data-og-description="2024년 제6차 체외진단의료기기 허가심사 온라인 민원설명회 발표자료를 첨부합니다. 업무에 참고하시기 바랍니다." data-og-host="www.nifds.go.kr" data-og-source-url="https://www.nifds.go.kr/brd/m_16/view.do?seq=7169&srchFr=&srchT..

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories (OSEL), CDRH  Today, the FDA’s Center for Devices and Radiological Health (CDRH) is announcing a partnership with the Bill and Melinda Gates Foundation to create new analytical met..

Even three weeks after the 2024 Hospitalar conference in Brazil, it is still worth highlighting some important points raised by Marcella de Abreu, GEVIT/ANVISA Manager, during her presentation covering the RDC 830/2023 legislation for in vitro diagnostic devices. This also serves as a reminder that RDC 830/2023 now applies to IVDs and products within the scope of IVDs in Brazil.Background on RDC..

SummaryOn July 16, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.  If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by June 28, 2024, to be considered for the discussion. Questions will ..

(출처: 한국의료기기산업협회) 식품의약품안전평가원 (체외진단기기과)에서 2024년 제6회 체외진단의료기기 허가심사 민원설명회가 개최됨을 안내하였다. ▶ 일시: 2024년 06월 28일(금) 13:30~14:30▶ 장소: 온라인 (webex 화상회의)▶ 주요내용: 최신심사요건 등 규제 업데이트  :: KOREA MEDICAL DEVICES INDUSTRY ASSOCIATION :: (kmdia.or.kr) :: KOREA MEDICAL DEVICES INDUSTRY ASSOCIATION :: www.kmdia.or.kr

식품의약품안전처에서는 '체외진단의료기기 소프트웨어 변경허가 사항'에 대하여 아래와 같이 유권해석하오니 관련 업무에 참고하여 주시기 바랍니다 (출처: 한국의료기기협동조합)  [식품의약품안전처] 체외진단의료기기 소프트웨어 변경허가 관련 유권해석 알림 – 한국의료기기협동조합 (medinet.or.kr) [식품의약품안전처] 체외진단의료기기 소프트웨어 변경허가 관련 유권해석 알림식품의약품안전처에서는 '체외진단의료기기 소프트웨어 변경허가 사항'에 대하여 다음과 같이 유권해석하오니 관련 업무에 참고하여 주시기 바랍니다.medinet.or.kr

This week the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a four-week public consultation seeking the views of various stakeholders to improve safety measures for high-risk IVDs by including Common Specification (CS) requirements in the UK legislation (Medical Devices Regulations 2002 (MDR 2002)). In addition, they also seek..