공포번호 35669
공포일 2025-07-22
식품의약품안전처
Ministry of Food and Drug Safety
전체선택
제1조(목적)
Article 1 (Purpose)
제2조(의료기기의 날 행사 등)
Article 2 (Events for Medical Device Day)
제3조 삭제 <2019. 10. 22.>
Article 3 Deleted.
제3조의2(위원의 제척ㆍ기피ㆍ회피)
Article 3-2 (Disqualification of, challenge to, and refrainment by, committee members)
제3조의3(위원의 해촉)
Article 3-3 (Dismissal of members)
제4조(위원장의 직무)
Article 4 (Duties of chairpersons)
제5조(회의)
Article 5 (Meetings)
제6조 삭제 <2022. 1. 18.>
Article 6 Deleted.
제7조(분과위원회 등)
Article 7 (Subcommittees)
제8조(연구위원)
Article 8 (Research members)
제9조(간사와 서기)
Article 9 (Executive secretary and clerks)
제10조(수당과 여비 등)
Article 10 (Allowances and travel expense)
제10조의2(판매업자ㆍ임대업자의 준수사항)
Article 10-2 (Matters to be observed by distributors and lessors)
제10조의3(광고의 자율심의 대상)
Article 10-3 (Media subject to voluntary deliberation of advertisements)
제10조의4(광고의 자율심의 및 재심의 절차 등)
Article 10-4 (Voluntary deliberation, procedures for re-deliberation of advertisements)
제10조의5(자율심의기구의 구성)
Article 10-5 (Organization of voluntary deliberation agency)
제10조의6(의료기기통합정보센터의 지정 및 업무 위탁)
Article 10-6 (Designation of and entrustment of duties to integrated medical device information center)
제11조(과징금의 산정기준)
Article 11 (Criteria for calculation of penalty surcharges)
제11조의2(위해 의료기기 제조 등에 대한 과징금의 부과기준)
Article 11-2 (Criteria for imposition of penalty surcharges for manufacture of harmful medical devices)
제12조(과징금의 부과 및 납부절차)
Article 12 (Procedures for imposition and payment of penalty surcharges)
제12조의2(과징금 미납자에 대한 처분)
Article 12-2 (Disposition on defaulters of penalty surcharges)
제12조의3(위반사실의 공표)
Article 12-3 (Announcement of violations)
제12조의4(한국의료기기안전정보원의 운영)
Article 12-4 (Operation of National Institute of Medical Device Safety Information)
제12조의5(보험 또는 공제의 가입 대상 및 종류 등)
Article 12-5 (Subjects and types of insurance or mutual aid)
제12조의6(의료기기책임보험등의 보험금액 등)
Article 12-6 (Insured amount of medical device liability insurance)
제13조(권한의 위임)
Article 13 (Delegation of authority)
제13조의2 삭제 <2021. 9. 7.>
Article 13-2 Deleted.
제13조의3(민감정보 및 고유식별정보의 처리)
Article 13-3 (Management of sensitive information and personally identifiable information)
제14조(과태료의 부과기준)
Article 14 (Criteria for imposition of administrative fines)
부칙 <제18401호, 2004. 5. 25.>
ADDENDA <Presidential Decree No. 18401, Nov. 25, 2004>
부칙 <제19513호, 2006. 6. 12.>
ADDENDA <Presidential Decree No. 19513, Jun. 12, 2006>
부칙 <제20157호, 2007. 7. 3.>
ADDENDUM <Presidential Decree No. 20157, Jul. 3, 2007>
부칙 <제20679호, 2008. 2. 29.>
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
부칙 <제22075호, 2010. 3. 15.>
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
부칙 <제22247호, 2010. 6. 30.>
ADDENDA <Presidential Decree No. 22247, Jun. 30, 2010>
부칙 <제23200호, 2011. 10. 7.>
ADDENDA <Presidential Decree No. 23200, Oct. 7, 2011>
부칙 <제23488호, 2012. 1. 6.>
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
부칙 <제24480호, 2013. 3. 23.>
ADDENDA <Presidential Decree No. 24480, Mar. 23, 2013>
부칙 <제25357호, 2014. 5. 21.>
ADDENDA <Presidential Decree No. 25357, May 21, 2014>
부칙 <제26375호, 2015. 6. 30.>
ADDENDA <Presidential Decree No. 26375, Jun. 30, 2015>
부칙 <제26844호,2015.12.31.>
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
부칙 <제27209호, 2016. 5. 31.>
ADDENDUM <Presidential Decree No. 27209, May 31, 2016>
부칙 <제28224호, 2017. 8. 1.>
ADDENDUM <Presidential Decree No. 28224, Aug. 1, 2017>
부칙 <제29158호, 2018. 9. 11.>
ADDENDUM <Presidential Decree No. 29158, Sep. 11, 2018>
부칙 <제29786호, 2019. 5. 21.>
ADDENDUM <Presidential Decree No. 29786, May 21, 2019>
부칙 <제30156호, 2019. 10. 22.>
ADDENDUM <Presidential Decree No. 30156, Oct. 22, 2019>
부칙 <제30511호, 2020. 3. 3.>
ADDENDUM <Presidential Decree No. 30511, Mar. 3, 2020>
부칙 <제30545호, 2020. 3. 24.>
ADDENDA <Presidential Decree No. 30545, Mar. 24, 2020>
부칙 <제30993호, 2020. 9. 8.>
ADDENDUM <Presidential Decree No. 30993, Sep. 8, 2020>
부칙 <제31013호, 2020. 9. 11.>
ADDENDA <Presidential Decree No. 31013, Sep. 11, 2020>
부칙 <제31380호, 2021. 1. 5.>
ADDENDUM <Presidential Decree No. 31380, Nov. 5, 2021>
부칙 <제31783호, 2021. 6. 15.>
ADDENDUM <Presidential Decree No. 31783, Jun. 15, 2021>
부칙 <제31974호, 2021. 9. 7.>
ADDENDA <Presidential Decree No. 31974, Sep. 7, 2021>
부칙 <제32014호, 2021. 9. 24.>
ADDENDA <Presidential Decree No. 32014, Sep. 24, 2021>
부칙 <제32348호, 2022. 1. 18.>
ADDENDUM <Presidential Decree No. 32348, Jan. 18, 2022>
부칙 <제32817호, 2022. 7. 19.>
ADDENDA <Presidential Decree No. 32817, Jul. 19, 2022>
부칙 <제33112호, 2022. 12. 20.>
ADDENDUM <Presidential Decree No. 33112, Dec. 20, 2022>
부칙 <제33913호, 2023. 12. 12.>
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
부칙 <제35250호, 2025. 2. 7.>
ADDENDUM <Presidential Decree No. 35250, Feb. 7, 2025>
부칙 <제35669호, 2025. 7. 22.>
ADDENDUM <Presidential Decree No. 35669, Jul. 22, 2025>