공포번호 17978
공포일 2021-03-23
식품의약품안전처
Ministry of Food and Drug Safety
전체선택
제1장 총칙
CHAPTER I GENERAL PROVISIONS
제1조(목적)
Article 1 (Purpose)
제2조(정의)
Article 2 (Definitions)
제3조(등급분류와 지정)
Article 3 (Classification and Designation of Classes)
제4조(다른 법률과의 관계)
Article 4 (Relationship to Other Statutes)
제2장 의료기기위원회
CHAPTER II MEDICAL DEVICES COMMITTEE
제5조(의료기기위원회)
Article 5 (Medical Devices Committee)
제3장 의료기기의 제조 등
CHAPTER III MANUFACTURING, ETC. OF MEDICAL DEVICES
제1절 제조업
Section 1 Manufacturing Business
제6조(제조업의 허가 등)
Article 6 (Manufacturing Business Permission, etc.)
제6조의2(품질책임자 준수사항 등)
Article 6-2 (Matters to be Observed by Quality Managers and other Relevant Matters)
제6조의3(제조허가 등의 제한)
Article 6-3 (Restrictions on Manufacturing Permission, etc.)
제6조의4(기술문서심사기관의 지정 등)
Article 6-4 (Designation, etc. of Institutions Reviewing Technical Documents)
제7조(조건부허가 등)
Article 7 (Conditional Permission, etc.)
제8조(신개발의료기기 등의 재심사)
Article 8 (Re-Examination of Newly Developed Medical Devices, etc.)
제9조(재평가)
Article 9 (Re-Evaluation)
제10조(임상시험계획의 승인 등)
Article 10 (Approval, etc. of Clinical Trial Plans)
제10조의2(비임상시험실시기관의 지정 등)
Article 10-2 (Designation, etc. of Institutions Conducting Non-Clinical Trials)
제11조(제조 허가ㆍ신고 등의 사전 검토)
Article 11 (Preliminary Review of Manufacturing Permission, Notification, etc.)
제12조(변경허가 등)
Article 12 (Permission, etc. for Change)
제13조(제조업자의 의무)
Article 13 (Obligations of Manufacturers)
제13조의2(경제적 이익등 제공 내역에 관한 지출보고서 제출 등)
Article 13-2 (Submission, etc. of Expense Reports on Details of Provision of Economic Profits, etc.)
제14조(폐업ㆍ휴업 등의 신고)
Article 14 (Notification of Permanent Closure, Temporary Shutdown, etc.)
제2절 수입업
Section 2 Import Business
제15조(수입업허가 등)
Article 15 (Import Business Permission, etc.)
제15조의2(희소ㆍ긴급도입 필요 의료기기의 공급 및 정보 제공 등)
Article 15-2 (Supply of, and Provision of Information on, Medical Devices Scarce or in Urgent Need of Introduction)
제3절 수리업
Section 3 Repair Business
제16조(수리업의 신고)
Article 16 (Notification on Repair Business)
제4절 판매업 및 임대업
Section 4 Distribution Business and Leasing Business
제17조(판매업 등의 신고)
Article 17 (Notification of Distribution Business, etc.)
제18조(판매업자 등의 준수사항)
Article 18 (Matters to be Observed by Distributors, etc.)
제4장 의료기기의 취급 등
CHAPTER IV HANDLING, ETC. OF MEDICAL DEVICES
제1절 기준
Section 1 Standards
제19조(기준규격)
Article 19 (Standard Specifications)
제2절 기재사항 및 광고
Section 2 Labeling and Advertisements
제20조(용기 등의 기재사항)
Article 20 (Labeling on Containers, etc.)
제21조(외부포장 등의 기재사항)
Article 21 (Labeling on Outer Package, etc.)
제22조(첨부문서의 기재사항)
Article 22 (Labeling on Package Inserts)
제23조(기재 시 주의사항)
Article 23 (Requirements for Labeling)
제24조(기재 및 광고의 금지 등)
Article 24 (Prohibition, etc. on Labeling and Advertisements)
제25조(광고의 자율심의)
Article 25 (Voluntary Deliberation of Advertisements)
제25조의2(자율심의기구 구성ㆍ운영 등)
Article 25-2 (Organization and Operation, etc. of Voluntary Deliberation Agency)
제25조의3(의료기기광고에 관한 심의위원회)
Article 25-3 (Deliberative Committees for Advertisements of Medical Devices)
제25조의4(의료기기광고 모니터링)
Article 25-4 (Monitoring Advertisements of Medical Devices)
제3절 취급
Section 3 Handling
제26조(일반행위의 금지)
Article 26 (General Prohibitions)
제27조(시험검사)
Article 27 (Testing and Inspections)
제28조(품질관리심사기관의 지정 등)
Article 28 (Designation, etc. of Quality Control Examination Agencies)
제5장 관리
CHAPTER V CONTROL
제29조(추적관리대상 의료기기)
Article 29 (Medical Devices Subject to Tracking and Control)
제30조(기록의 작성 및 보존 등)
Article 30 (Preparation, Preservation, etc. of Records)
제31조(부작용 관리)
Article 31 (Control of Side Effects)
제31조의2(의료기기 공급내역 보고 등)
Article 31-2 (Reports, etc. on Details of Supply of Medical Devices)
제31조의3(의료기기통합정보시스템 구축 등)
Article 31-3 (Establishment, etc. of Integrated Medical Device Information System)
제31조의4(의료기기통합정보센터 지정ㆍ운영 등)
Article 31-4 (Designation and Operation, etc. of Integrated Medical Device Information Center)
제31조의5(의료기기 이물 발견 보고 등)
Article 31-5 (Reporting on Detection of Foreign Substances in Medical Devices)
제6장 감독
CHAPTER VI SUPERVISION
제32조(보고와 검사 등)
Article 32 (Reporting, Inspection, etc.)
제32조의2(해외제조소에 대한 현지실사 등)
Article 32-2 (On-Site Inspection of Foreign Factories)
제33조(검사명령)
Article 33 (Inspection Orders)
제34조(회수ㆍ폐기 및 공표 명령 등)
Article 34 (Orders for Recall, Destruction, Public Announcement and Other Relevant Matters)
제35조(사용중지명령 등)
Article 35 (Orders for Suspension of Use, etc.)
제35조의2(시정명령)
Article 35-2 (Corrective Order)
제36조(허가 등의 취소와 업무의 정지 등)
Article 36 (Revocation of Permission, etc., Suspension of Business Activities, and Relevant Matters)
제37조(지정의 취소 등)
Article 37 (Revocation of Designation, etc.)
제38조(과징금처분)
Article 38 (Imposition of Penalty Surcharges)
제38조의2(위반사실 공표)
Article 38-2 (Announcement of Violations)
제39조(청문)
Article 39 (Hearings)
제40조(의료기기 감시원)
Article 40 (Medical Device Surveillance Officers)
제40조의2(소비자의료기기감시원)
Article 40-2 (Customer Medical Device Surveillance Officers)
제7장 보칙
CHAPTER VII SUPPLEMENTARY PROVISIONS
제41조 삭제 <2019. 4. 30.>
Article 41 Deleted.
제42조(한국의료기기안전정보원의 설립)
Article 42 (Establishment of National Institute of Medical Device Safety Information)
제43조(정보원의 사업)
Article 43 (Business Activities of the Information Institute)
제43조의2(인증ㆍ신고의 취소)
Article 43-2 (Revocation of Certification or Notification)
제43조의3(정보원의 지도ㆍ감독 등)
Article 43-3 (Guidance and Supervision of the Information Institute)
제43조의4(자료제공의 요청)
Article 43-4 (Request for Materials)
제43조의5(인과관계조사관)
Article 43-5 (Investigator of Causal Relations)
제44조(권한의 위임 및 위탁)
Article 44 (Delegation and Entrustment of Authority)
제44조의2(벌칙 적용에서 공무원 의제)
Article 44-2 (Legal Fiction as Public Officials in Application of Penalty Provisions)
제45조(제출자료의 보호)
Article 45 (Protection of Submitted Data)
제46조(동물용 의료기기에 대한 특례)
Article 46 (Special Cases on Medical Devices for Animals)
제46조의2 삭제 <2021. 3. 9.>
Article 46-2 Deleted.
제47조(제조업자등의 지위 승계 등)
Article 47 (Succession to Status of Manufacturers and Relevant Matters)
제48조(행정제재처분 효과의 승계)
Article 48 (Transfer of Effects of Administrative Sanctions)
제49조(제조허가등의 갱신)
Article 49 (Renewal of Manufacturing Permission, etc.)
제50조(수수료)
Article 50 (Fees)
제8장 벌칙
CHAPTER VIII PENALTY PROVISIONS
제51조(벌칙)
Article 51 (Penalty Provisions)
제52조(벌칙)
Article 52 (Penalty Provisions)
제53조(벌칙)
Article 53 (Penalty Provisions)
제53조의2(벌칙)
Article 53-2 (Penalty Provisions)
제54조(벌칙)
Article 54 (Penalty Provisions)
제54조의2(벌칙)
Article 54-2 (Penalty Provisions)
제55조(양벌규정)
Article 55 (Joint Penalty Provisions)
제56조(과태료)
Article 56 (Administrative Fines)
부칙 <제10564호, 2011. 4. 7.>
ADDENDA <Act No. 10564, Apr. 7, 2011>
부칙 <제11690호, 2013. 3. 23.>
ADDENDA <Act No. 11690, Mar. 23, 2013>
부칙 <제11985호, 2013. 7. 30.>
ADDENDA <Act No. 11985, Jul. 30, 2013>
부칙 <제11998호, 2013. 8. 6.>
ADDENDA <Act No. 11998, Aug. 6, 2013>
부칙 <제12107호, 2013. 8. 13.>
ADDENDA <Act No. 12107, Aug. 13, 2013>
부칙 <제12392호, 2014. 1. 28.>
ADDENDA <Act No. 12392, Jan. 28, 2014>
부칙 <제13116호, 2015. 1. 28.>
ADDENDA <Act No. 13116, Jan. 28, 2015>
부칙 <제13698호, 2015. 12. 29.>
ADDENDA <Act No. 13698, Dec. 29, 2015>
부칙 <제14330호, 2016. 12. 2.>
ADDENDA <Act No. 14330, Dec. 2, 2016>
부칙 <제15279호, 2017. 12. 19.>
ADDENDA <Act No. 15279, Dec. 19, 2017>
부칙 <제15486호, 2018. 3. 13.>
ADDENDA <Act No. 15486, Mar. 13, 2018>
부칙 <제15945호, 2018. 12. 11.>
ADDENDA <Act No. 15945, Dec. 11, 2018>
부칙 <제16402호, 2019. 4. 23.>
ADDENDA <Act No. 16402, Apr. 23, 2019>
부칙 <제16405호, 2019. 4. 30.>
ADDENDA <Act No. 16405, Dec. 30, 2019>
부칙 <제17007호, 2020. 2. 18.>
ADDENDA <Act No. 17007, Feb. 18, 2020>
부칙 <제17091호, 2020. 3. 24.>
ADDENDA <Act No. 17091, Mar. 24, 2020>
부칙 <제17248호, 2020. 4. 7.>
ADDENDA <Act No. 17248, Apr. 7, 2020>
부칙 <제17472호, 2020. 8. 11.>
ADDENDA <Act No. 17472, Aug. 11, 2020>
부칙 <제17922호, 2021. 3. 9.>
ADDENDA <Act No. 17922, Mar. 9, 2021>
부칙 <제17978호, 2021. 3. 23.>
ADDENDA <Act No. 17978, Mar. 23, 2021>