[MDREX 뉴스레터] 디지털의료제품법 시행에 따른 식약처 가이드라인 발표

디지털의료제품법 시행에 따른 식약처 가이드라인 발표
2025.02.04

디지털의료제품법이 2025.01.24일 시행됨에 따라, 식품의약품안전처(이하 식약처)에서는 “디지털의료제품 법령 시행에 따른 업무 안내서(가이드라인)”를 발간하여 배포하였습니다. 동 가이드라인에서는 디지털의료제품법 적용대상 제품, 분류 및 등급 지정 방법, 업 허가 및 제품에 대한 허가/인증/신고 절차, 임상시험계획 승인 면제기준, KGMP 인증 절차, 전자적 침해행위 보안 방법, 우수 관리체계 인증, 표시기재 사항 및 관리/감독/벌칙 내용 등을 포함하고 있으며, FAQ을 통해 자주 묻는 질문에 대한 답변을 제공하고 있습니다.

이에, 디지털의료제품법 적용에 있어 관심이 있을 만한 FAQ 내용을 정리해 보았습니다.
 
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MDREX is a boutique Korea Medical Device Regulatory, Quality, Compliance,
Reimbursement and Clinical Consulting Firm dedicated to providing strategic and
operational consulting services to Digital Health and Medical Device Companies.

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