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[Emergo, UL] QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485

The medical device regulator in South Africa, the South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System (QMS) developments.SAHPRA joins MDSAPSAHPRA announced (April 4, 2025) affiliate member status has been bestowed upon the Medical Device Single Audit Program (MDSAP). SAHPRA Chief Executive Officer Dr. Boitumelo Semete-Makokotlela hailed ..

We reported in August of 2024, about the publication of a revised draft of the Mexican Standard for Good Manufacturing Practices for Medical Devices, titled PROY-NOM-241-SSA1-2024. In Mexico, a Norma Oficial Mexicana (Official Mexican Standard, NOM), is compulsory. We discussed some of the notable changes proposed by COFEPRIS in contrast with the previous 2021 version of the standard, subject to..

The U.S. Food and Drug Administration (FDA) has opened the test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) in preparation for the official launch at 9:00 a.m. ET on April 14, 2025. The testing phase will conclude after April 11, and the existing (legacy ESG) system will be disabled at midnight Eastern time (ET) on April 12. No submissions can be made i..

Introduction to the EUDAMED Workshop The European Commission is organising a free registration hybrid workshop in Stuttgart to support the EUDAMED onboarding of all concerned actors, in view of the mandatory use of Actors, UDI/Devices, Notified bodies and Certificates and Market surveillance modules of the system. The workshop will provide an overview of the obligations under the Medical Devices..

Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.The AI Act is now part of the new legislative frameworkThe AI Act is a new part of the new legislative framework and also applies to medical devices and IVD..

The first three months of 2025 have ended and our team has been ardently sharing regulatory news. No particular regulatory update was heralded as groundbreaking (other than news of an agreement between the Malaysia Medical Device Authority (MDA) and China NMPA to ease regulatory requirements for certain classes of devices). Progress from the International Medical Device Regulators Forum (IMDRF) ..

Court decision on LDTsOn March 31, 2025, the US District Court (Eastern District of Texas, Sherman Division) ruled that the FDA’s Final Rule on Laboratory Developed Tests (LDTs) published in 2024, which phases out enforcement discretion and phases in standard medical device requirements, be vacated and set aside. This court determined that Congress has vested authority of test services to the Ce..

한국체외진단의료기기협회가 임상적성능시험 종사자 교육기간으로 지정되어, 상시 온라인과정을 개설하였다. ▶ 교육명- 심사자(IRB), 모니터요원, 시험책임자 및 담당자 각 과정의 기본 / 전문(1)- 보수과정, 임상적 성능시험 통계기법 ▶ 교육기간2025년 03월 26일 ~ 12월 12일(금)까지 ▶ 교육목표임상적 성능시험기관 종사자 역량강화를 통한 체외진단의료기기의 안전성 확보 및 품질향상 ▶ 접수기간2025년 03월 26일 ~ 12월 12일(금) ▶ 모집인원제한없음 ▶ 교육비무료 (2025년) ▶ 교육대상체외진단의료기기 임상적 성능시험 종사자  2025년 체외진단의료기기 임상적 성능시험 종사자 상시 온라인 교육 안내(의무 교육) > 공지사항 | 한국체외진단의료기기협회 KIVDA 한국체외진단의료기기협회식품..

As Notified Bodies (NBs) in the European Union (EU) begin to roll out Article 16(4)  of the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR)  certification schemes, we at Emergo by UL share our insights on the requirements set out in Article 16 and their applicability to importers, distributors and other natural or ..

Importance of reviewing warning lettersBy reviewing relevant U.S. Food and Drug Administration (FDA) warning letters, manufacturers can better understand areas of frequent concern related to quality management systems (QMS) and regulatory affairs. This can allow companies to focus on areas of highest risk as they continually assess and improve their internal procedures and processes. It also hel..