의료기기 이야기

식품의약품안전처에서는 '미국 FDA 의료기기 품질경영시스템 규정'의 개정사항을 설명하는 정보집을 4월 30일 발간하였다. 주요 개정사항은 '의료기기 품질경영시스템 적용 범위 명확화', '용어 정의 설명', '미국 법령에 따른 별도 요구사항' 추가 등이며 개정된 규정은 오는 2026년 2월 시행될 예정이다.  식품의약품안전처>법령/자료>홍보물자료>일반홍보물 - 상세보기 | 식품의약품안전처 (mfds.go.kr)법령/자료>홍보물자료>일반홍보물 | 식품의약품안전처" data-og-description="미국 품질경영시스템 규정( QMSR) 정보집 분야 #의료기기#품질관리 등록일 2024-04-30 조회수 307 '미국 의료기기 품질경영시스템 규정 정보집'을 게시합니다. 첨부파일 첨부파일 전체 다운로드 --> ..

Emergo에서 아래와 같이 웨비나를 개최한다. ​ ▶ 주제: Singapore HSA - Thai FDA Reliance Program for Medical Devices ▶ 일시: 2024년 04월 18일 CST 9시 (한국시간: 04월 18일 23시) Join us on April 18 for an insightful webinar led by our subject matter expert Sreenu Sattu. He will provide a comprehensive overview of the latest Thai FDA Reliance Program and its impact on facilitating the registration process in Thailand, particularl..

Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together The U.S. Food and Drug Administration (FDA) issued "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," which outlines the agency's commitment and cross-center collaboration to protect public health while fostering responsible and ethical medical product..

Emergo에서 아래와 같이 웨비나를 개최한다. ​ ▶ 주제: In-house tests under EU IVDR - How to best meet your IVDR deadlines ▶ 일시: 2024년 02월 28일 CST 9시 (한국시간: 03월 13일 23시) The presenter will provide more details on how to be best prepared for an external audit (FDA, MDSAP, ISO, etc.), as well as a practical approach to what to do before the audit and common pitfalls based on industry experience. We will also highligh..

식품의약품안전처와 미국 FDA는 의료제품 발전을 위한 인공지능 (AI) 활용이라는 주제로 심포지엄 (AIRIS 2024)을 공동 개최하였다. ▶ 일시: 2024년 02월 26일 ~ 29일 ▶ AIRIS: AI Regulatory & International Symposium 식품의약품안전처>알림>언론홍보자료>보도자료 - 상세보기 | 식품의약품안전처 (mfds.go.kr) 식품의약품안전처>알림>언론홍보자료>보도자료 | 식품의약품안전처 식약처, 미국 FDA와 함께 AI 의료제품 활성화 위한 글로벌 논의 주도 식약처, 미국 FDA와 함께 AI 의료제품 활성화 위한 글로벌 논의 주도 첨부파일 첨부파일 전체 다운로드 --> 2.21.글로벌수출전략 www.mfds.go.kr

In Vitro Diagnostic (IVD) devices are a critical component of healthcare, as they help users diagnose conditions and formulate an appropriate treatment plan for a patient. In some cases, they may also be used for care management for certain diseases. In the U.S., IVDs are regulated like other medical devices and divided into one of three classes, each with its own general expectations for a spec..

Perhaps you have an idea for a medical device that could revolutionize medical care in the US, or perhaps for an improvement that could increase a device's safety or effectiveness. Bringing an innovative device to the U.S. market can present many challenges but also rewards. The US Food and Drug Administration (FDA) wants to encourage improvements to the overall safety and effectiveness of medic..

This guidance document updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that we recommend sponsors include in a 510(k) submission. For the current edition of the FDA-recognized standards referenced in this document, s..

The US Food and Drug Administration (FDA) has begun issuing export documents for medical devices in electronic format in order to help streamline processes and reduce time and effort for manufacturers seeking to sell their products in non-US markets. A letter to industry from FDA explains that the agency’s transition to electronic formats took effect January 2, 2024, and applies to documents suc..

Earlier this month I wrote about the importance of clinical trial transparency and the FDA’s oversight. Today, I’d like to catch up with you about another critical component of FDA’s oversight of clinical studies: our work to harmonize clinical research regulations and to facilitate the development of medical products to benefit public health. Modernizing Clinical Research Oversight Efficient, w..