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REGNA selects and summarises Korean statutes and notices as they are made or amended, Korean regulatory trends, and developments from the FDA, the EU, MDSAP and elsewhere. Every item carries a link to the primary source, and you read it without signing in.
전체 119건 · 최신 2026. 9. 15.
Korea식약처, 디지털치료기기 임상시험계획서 작성 가이드라인 개정 — 7개 적응증, MCID 심사기준 반영2026. 9. 10. · 식약처 · 식품의약품안전평가원
Statutes & notices의료기기 시판 후 조사에 관한 규정2026. 8. 31. · 식약처 · 국가법령정보센터
Korea식약처, MDSAP 심사 대응 가이드라인 3종 발간 — 전기수술기·조직수복용생체재료·초음파영상진단장치2026. 8. 28. · 식약처 · 의료기기관리과
- 2026. 9. 15. 의료기기법
- 2026. 9. 10. 식약처, 디지털치료기기 임상시험계획서 작성 가이드라인 개정 — 7개 적응증, MCID 심사기준 반영
- 2026. 9. 2. Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
- 2026. 9. 2. Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
- 2026. 8. 31. 의료기기 시판 후 조사에 관한 규정
- 2026. 8. 28. 식약처, MDSAP 심사 대응 가이드라인 3종 발간 — 전기수술기·조직수복용생체재료·초음파영상진단장치
- 2026. 8. 10. 체외진단의료기기 허가ㆍ신고ㆍ심사 등에 관한 규정
- 2026. 8. 3. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- 2026. 7. 27. 디지털의료제품 허가·인증·신고·심사 및 평가 등에 관한 규정
- 2026. 7. 23. Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
- 2026. 7. 21. 의료기기 기술문서심사기관 지정 및 운영 등에 관한 규정
- 2026. 7. 1. 의료기기법 시행규칙
- 2026. 7. 1. 의료기기 제조 및 품질관리 기준
- 2026. 7. 1. 의료기기 제조 및 품질관리 관련 기관 지정 등에 관한 규정
- 2026. 6. 30. 체외진단의료기기 품목 및 품목별 등급에 관한 규정
- 2026. 6. 23. 의료기기법 시행령
- 2026. 6. 19. 브라질 ANVISA, 해외 동등규제당국(AREE) 활용 확대 추진 — 의료기기 규제 신뢰(reliance) 경로 점검
- 2026. 6. 19. MDSAP 심사접근 문서 P0002.010 개정 — FDA QMSR 정합으로 QSR 인용 삭제, AI/PCCP 반영
- 2026. 6. 19. ISO, 생물학적 안전성 평가 기본표준 ISO 10993-1 제6판 발간 — 위험관리(ISO 14971) 정합으로 전면 재편, 표준명까지 변경
- 2026. 6. 19. 호주 TGA, AI 기반 소프트웨어 의료기기(SaMD) 규제 적용 신규 가이던스 발간 — "기술이 아니라 사용목적이 규제 진입 기준"
- 2026. 6. 19. 유럽집행위, 인증기관(NB) 적합성평가 통일 요건 시행규정 (EU) 2026/977 채택 — 견적 비용내역 의무·최대 처리기한 도입, 2027년 2월 25일 적용
- 2026. 6. 15. (EU) 2026/1313 — Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer
- 2026. 6. 11. (EU) 2026/1231 — Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, symbols to be used with information to be supplied by the manufacturer, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics and sharps injury protection
- 2026. 6. 5. FDA CDRH 가이던스 2025~2026 발행 목록 (29건·원문 링크)
- 2026. 6. 5. Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff
- 2026. 5. 29. FDA, 의료기기 마케팅 제출 시 인적요인(Human Factors) 정보 요건 최종 가이던스 확정
- 2026. 5. 29. Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff
- 2026. 5. 19. FDA PMA 원허가 다이제스트 — 2025~2026 신규 고위험 승인 57건
- 2026. 5. 7. Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff
- 2026. 4. 28. 2025~2026 의료기기 법령·고시 개정 전수 (32건·원문 링크)
- 2026. 4. 28. 의료기기 허가ㆍ신고ㆍ심사 등에 관한 규정
- 2026. 4. 20. EU MDCG, MDR 의료기기 분류 가이던스 개정 — 이식형 기기·능동기기 해석 명확화
- 2026. 4. 20. Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff
- 2026. 4. 10. IMDRF, AI 의료기기 생애주기 관리 기술 프레임워크 초안 공개 의견 수렴
- 2026. 4. 1. (EU) 2026/760 — Commission Implementing Decision (EU) 2026/760 of 1 April 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilizers for medical purposes – small steam sterilizers, stainless steel steam boilers and electroacoustics – hearing aids
- 2026. 3. 31. 의료기기 수입요건확인 면제 등에 관한 규정
- 2026. 3. 31. 의료기기 허가·심사 규정 행정예고 — 실사용증거 인정 범위 확대·비영어 외국어 자료 공증 폐지
- 2026. 3. 30. Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties
- 2026. 3. 20. EU, MDR 개정 위임규정 (EU) 2026/1359 — 기기별 기술문서 평가 의무가 면제되는 IIb등급 이식형 기기 목록 개정
- 2026. 3. 20. EU, MDR 개정 위임규정 (EU) 2026/1451 — 임상시험 수행 의무가 면제되는 이식형·III등급 기기 목록 개정
- 2026. 3. 13. Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff
- 2026. 3. 9. 의료기기 품목 및 품목별 등급에 관한 규정
- 2026. 3. 9. 의료기기 품목·등급 규정 개정 — 근시진행 억제 안경렌즈 등 4개 품목 신설·인상 전 처치제 1등급 하향 (고시 제2026-18호)
- 2026. 3. 3. 의료기기법 시행규칙 개정안 입법예고 — 경미변경 자율관리 전환·회수기준 명확화
- 2026. 2. 28. 의료기기 기준규격 2025-08 개정(2026-02-28 시행) + 공통기준규격 정비
- 2026. 2. 3. FDA 의료기기 사이버보안 — QMS·시판전제출 가이던스 Final(2026-02) 과 524B
- 2026. 2. 3. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff
- 2026. 2. 3. Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff
- 2026. 1. 29. FDA, 임상의사결정지원(CDS) 소프트웨어 최종 가이던스 발행 — 규제 대상 범위 명확화
- 2026. 1. 29. Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff
- 2026. 1. 28. (EU) 2026/193 — Commission Implementing Decision (EU) 2026/193 of 28 January 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, non-active surgical implants, sterilization of health care products, biocompatibility evaluation of breathing gas pathways in healthcare applications and small-bore connectors for liquids and gases in healthcare applications
- 2026. 1. 28. (EU) 2026/197 — Commission Implementing Decision (EU) 2026/197 of 28 January 2026 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of health care products and information supplied by the manufacturer (labelling)
- 2026. 1. 26. 체외진단의료기기 허가·신고·심사 등에 관한 규정
- 2026. 1. 26. 디지털의료제품 허가·인증·신고·심사 및 평가 등에 관한 규정
- 2026. 1. 26. 의료기기 허가·신고·심사 규정 개정 — 사이버보안 근거 명확화·1등급 변경신고 유예 6개월 도입
- 2026. 1. 24. 디지털의료제품법 체계 본격 가동 — 시행령·시행규칙·하위 6개 고시 한눈에
- 2026. 1. 23. 디지털의료제품법 시행규칙
- 2026. 1. 23. 디지털의료제품법에 따른 기관 지정 등에 관한 규정
- 2026. 1. 23. 디지털의료제품 분류 및 등급 지정 등에 관한 규정
- 2026. 1. 23. Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff
- 2026. 1. 22. 희소·긴급도입 필요 의료기기 공급 등에 관한 규정
- 2026. 1. 6. General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff
- 2026. 1. 2. 체외진단의료기기법 시행규칙
- 2026. 1. 1. 범부처 첨단 의료기기 연구개발사업 운영관리규정
- 2025. 12. 30. 의료기기산업 육성 및 혁신의료기기 지원법
- 2025. 12. 30. 의료기기법
- 2025. 12. 30. 의료기기산업 육성 및 혁신의료기기 지원법 시행령
- 2025. 12. 19. 생산·수입 중단 보고대상 의료기기 및 보고 방법
- 2025. 12. 18. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- 2025. 12. 16. (EU) 2025/2526 — Commission Implementing Regulation (EU) 2025/2526 of 16 December 2025 amending Implementing Regulation (EU) 2023/2713 to correct the designation of an EU reference laboratory and to designate European Union reference laboratories for in vitro diagnostic medical devices intended for detection or quantification of markers of parasite infection and detection of blood grouping markers
- 2025. 12. 9. 의료기기 제조 및 품질관리 기준(GMP) 2025-12 개정 — 점검 포인트
- 2025. 12. 9. 의료기기 제조 및 품질관리 기준
- 2025. 12. 9. 의료기기 이물 보고대상 및 절차 등에 관한 규정
- 2025. 12. 9. 의료기기 GMP 고시 개정 — 필수·응급기기 우선심사·위수탁 중복심사 해소 (고시 제2025-80호)
- 2025. 12. 3. eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff
- 2025. 11. 26. EU, EUDAMED 전자시스템 기능 충족 공식 확인 (결정 2025/2371)
- 2025. 11. 25. 의료기기 생산 및 수출·수입·수리실적 보고에 관한 규정
- 2025. 11. 21. 체외진단의료기기 품목 및 품목별 등급에 관한 규정
- 2025. 10. 31. 의료기기법 시행규칙
- 2025. 10. 28. Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff
- 2025. 10. 27. Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff
- 2025. 10. 17. (EU) 2025/2078 — Commission Implementing Decision (EU) 2025/2078 of 17 October 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for surgical clothing and drapes, medical face masks and sterilizers for medical purposes
- 2025. 10. 17. (EU) 2025/2086 — Commission Implementing Regulation (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments
- 2025. 10. 1. 의료기기산업 육성 및 혁신의료기기 지원법
- 2025. 9. 23. Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff
- 2025. 9. 18. 의료기기 기술문서심사기관 지정 및 운영 등에 관한 규정
- 2025. 8. 27. 의료기기 기준규격
- 2025. 8. 22. Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
- 2025. 8. 20. 장기추적조사 대상 의료기기 지정·실사용정보 제출 규정 제정(2025-08)
- 2025. 8. 20. 장기추적조사대상 의료기기 지정 및 실사용 정보 제출에 관한 규정
- 2025. 8. 18. FDA AI 의료기기 PCCP 가이던스(2025-08) — '사전 변경관리계획'의 핵심
- 2025. 8. 18. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
- 2025. 8. 12. 체외진단의료기기 제조 및 품질관리 기준
- 2025. 7. 31. Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
- 2025. 7. 22. 의료기기법 시행령
- 2025. 7. 7. (EU) 2025/1324 — Commission Implementing Decision (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devices
- 2025. 6. 25. (EU) 2025/1234 — Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form
- 2025. 6. 17. 의료기기의 전기·기계적 안전에 관한 공통기준규격
- 2025. 6. 17. 의료기기의 생물학적 안전에 관한 공통기준규격
- 2025. 6. 17. 인터넷 홈페이지 형태 첨부문서 제공 가능 의료기기의 지정에 관한 규정
- 2025. 6. 12. EU, MDR 부속서 VI 개정 — UDI 적용 대상에 안경테·안경렌즈 등 추가 (위임규정 2025/1920)
- 2025. 6. 6. Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff
- 2025. 6. 5. Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff
- 2025. 5. 29. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration Staff
- 2025. 5. 29. Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
- 2025. 4. 29. 디지털의료기기 전자적 침해행위 보안 지침
- 2025. 4. 24. 디지털의료기기 임상시험등 계획 승인 및 실시·관리에 관한 규정
- 2025. 4. 21. 디지털의료기기 제조 및 품질관리 기준
- 2025. 4. 8. (EU) 2025/681 — Commission Implementing Decision (EU) 2025/681 of 8 April 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances
- 2025. 4. 8. (EU) 2025/679 — Commission Implementing Decision (EU) 2025/679 of 8 April 2025 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of medical devices
- 2025. 3. 31. Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff
- 2025. 1. 31. 의료기기법
- 2025. 1. 24. (EU) 2025/117 — Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices
- 2025. 1. 23. 디지털의료제품법 시행령
- 2025. 1. 13. Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff
- 2025. 1. 7. Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff
- 2025. 1. 7. Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration S
- 2025. 1. 7. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff
- 2025. 1. 6. Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff
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