의료기기 이야기

식품의약품안전처는 2025년도 의료기기 임상시험 관리자료 및 실시상황보고 보고기한을 안내하였다. ▶ 기준: 의료기기법 제10조 및 같은법 시행규칙 제24조제1항▶ 보고대상: 2024년 01월 01일 ~ 2024년 12월 31일까지 실시한 임상시험▶ 보고기한: 2025년 02월 28일까지  식품의약품안전처>알림>공지/공고>공지 - 상세보기 | 식품의약품안전처알림>공지/공고>공지 | 식품의약품안전처" data-og-description="2025년도 의료기기 임상시험 관리자료 및 실시상황보고 보고기한 도래 알림 및 작성방법 안내 게시판태그 등록일 2025-02-05 조회수 1804 의료기기법 제10조 및 같은 법 시행규칙 제24조 제1항 관련 [" data-og-host="www.mfds.go.kr" dat..

식품의약품안전처에서 '의료기기 산업 육성 및 혁신의료기기 지원법' 제21조 및 같은 법 시행령 제15조에 따라 혁신의료기기로 아래와 같이 지정을 하였다. ▶혁신의료기기 (일반 제86호)     - 업체: 한국오츠카제약(주)     - 의료혁신군     - 품목명: 초음파수술기     - 제품명 / 모델명: - / Paradise Ultrasound Renal Denervation System  식품의약품안전처>알림>공지/공고>공고 - 상세보기 | 식품의약품안전처알림>공지/공고>공고 | 식품의약품안전처" data-og-description="혁신의료기기 지정 공고(일반 제86호) 등록일 2025-02-06 조회수 1038 식품의약품안전처 공고 제2025-057호 「의료기기 산업 육성 및 혁신의료기기 지원법..

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently released its 2024 Annual Report (link currently broken, but we will post once available from CDRH) highlighting some of its achievements over the past year. This is a summary of the main topics.The US FDA CDRH in 2024The CDRH is responsible for regulating medical devices in the U.S. It..

식품의약품안전처에서 의료기기 제조, 수입업체의 품목갱신을 위한 자료 준비에 도움을 주고자 '의료기기 최신의 기준규격 현황'을 조사하여 안내문을 마련하였다.  식품의약품안전처>법령/자료>홍보물자료>일반홍보물 - 상세보기 | 식품의약품안전처법령/자료>홍보물자료>일반홍보물 | 식품의약품안전처" data-og-description="[안내문_품목갱신] 의료기기 최신의 기준규격 현황 의료기기 제조·수입 업체의 품목갱신을 위한 자료 준비에 도움을 주고자 '의료기기 최신의 기준규격 현황'을 조사하여 첨부와 같이 안내문을" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_227/view.do?seq=33362&srchFr=&s..

Understanding pen-injector use errors and their implicationsThe proliferation of pen-injectors used by laypeople for self-administration of medication in their homes has caused regulators, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to task manufacturers with providing sufficient evidence to demonstrate that all users, especially laypeopl..

Why pilot tests are essential for usability studiesDeveloping a methodology for usability studies can involve uncertainty and introduce questions such as “How long should the test session last?,” “How can I improve my setup?” or “Is this prompt clear enough?” Running pilot test sessions prior to formal testing can help you find answers to these questions and increase the data quality of your upc..

What is the European Medical Device Nomenclature?Recently we updated you on Regulation (EU) 2024/1860 and how this amendment introduces a new approach on mandatory use of certain EUDAMED modules. Currently, 3 modules are live and those modules are expected to become mandatory in the upcoming year. One of the modules is the UDI/Device module. This module requires manufacturers to register their d..

Why a known problems analysis is crucial for NMPA complianceA known problems analysis (KPA) is a human factors engineering (HFE) activity that aims to identify use issues and user interface flaws with devices currently on the market. Regulators require medical device manufacturers to conduct a KPA to investigate use problems associated with devices that are similar to a device under development ..

The International Medical Device Regulators Forum (IMDRF) released two key documents related to medical device software: Good machine learning practice for medical device development: Guiding principles (IMDRF/AIML WG/N88 FINAL:2025); and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents are aimed at improving g..

The IVD expert panel has provided new scientific advice on SARS-CoV-2. The advice highlights that while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.  This information may affect how SARS-CoV-2 tests are classified under Regulation (EU) 2017/746. Manufacturers are encouraged to assess h..