No. 20888
Promulgation Date 2025-04-01
Ministry of Food and Drug Safety
ALL
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
Article 2 (Definitions)
Article 2-2 (Medical Device Day)
Article 3 (Classification and designation of classes)
Article 4 (Relationship to other statutes)
Article 4-2 (Comprehensive plans for safety management of medical devices)
CHAPTER II MEDICAL DEVICES COMMITTEE
Article 5 (Medical Devices Committee)
CHAPTER III MANUFACTURING OF MEDICAL DEVICES
SECTION 1 Manufacturing Business
Article 6 (Manufacturing business permission)
Article 6-2 (Matters to be observed by quality managers and other relevant matters)
Article 6-3 (Restrictions on manufacturing permission)
Article 6-4 (Designation of institutions reviewing technical documents)
Article 7 (Conditional permission)
Article 8 (Post market surveillance of newly developed medical devices)
Article 8-2 (Follow-up measures after post market surveillance of newly developed medical devices)
Article 9 (Re-evaluation)
Article 10 (Approval of clinical trial plans)
Article 10-2 (Designation of institutions conducting non-clinical trials)
Article 11 (Preliminary review of manufacturing permission, notification)
Article 12 (Permission for change)
Article 13 (Obligations of manufacturers)
Article 13-2 (Submission of expense reports on details of provision of economic profits)
Article 14 (Notification of permanent closure, temporary shutdown)
SECTION 2 Import Business
Article 15 (Import business permission)
Article 15-2 (Supply of, and provision of information on, medical devices scarce or in urgent need of introduction)
SECTION 3 Repair Business
Article 16 (Notification on repair business)
SECTION 4 Distribution Business and Leasing Business
Article 17 (Notification of distribution business)
Article 18 (Matters to be observed by distributors)
Article 18-2 (Notification of medical device sales promoters)
Article 18-3 (Education for medical device sales promoters)
Article 18-4 (Matters to be observed by medical device sales promoters)
Article 18-5 (Prohibition of opening and distribution)
CHAPTER IV HANDLING OF MEDICAL DEVICES
SECTION 1 Standards
Article 19 (Standard specifications)
SECTION 2 Labeling and Advertisements
Article 20 (Labeling on containers)
Article 21 (Labeling on outer package)
Article 22 (Labeling on package inserts)
Article 23 (Requirements for labeling)
Article 23-2 (Provision of information for persons with visual disabilities)
Article 24 (Prohibition on labeling and advertisements)
Article 25 (Voluntary deliberation of advertisements)
Article 25-2 (Organization and operation of voluntary deliberation agency)
Article 25-3 (Deliberative Committees for advertisements of medical devices)
Article 25-4 (Monitoring advertisements of medical devices)
Article 25-5 (Sealing)
SECTION 3 Handling
Article 26 (General prohibitions)
Article 27 (Testing and inspections)
Article 28 (Designation of quality management examination agencies)
CHAPTER V CONTROL
Article 29 (Medical devices subject to tracking and control)
Article 30 (Preparation, preservation of records)
Article 31 (Control of side effects)
Article 31-2 (Reports on details of supply of medical devices)
Article 31-3 (Establishment of integrated medical device information system)
Article 31-4 (Designation and operation of integrated medical device information center)
Article 31-5 (Reporting on detection of foreign substances in medical devices)
CHAPTER VI SUPERVISION
Article 32 (Reporting, inspection)
Article 32-2 (On-site inspection of foreign factories)
Article 33 (Inspection orders)
Article 34 (Orders for suspension of distribution, recall, destruction, and public announcement)
Article 35 (Orders for suspension of use)
Article 35-2 (Corrective order)
Article 36 (Revocation of permission, suspension of business activities, and relevant matters)
Article 37 (Revocation of designation)
Article 38 (Imposition of penalty surcharges)
Article 38-2 (Imposition of penalty surcharges for manufacturing of hazardous medical devices)
Article 38-3 (Announcement of violations)
Article 39 (Hearings)
Article 40 (Medical device surveillance officers)
Article 40-2 (Customer medical device surveillance officers)
CHAPTER VII SUPPLEMENTARY PROVISIONS
Article 41 Deleted.
Article 42 (Establishment of National Institute of Medical Device Safety Information)
Article 43 (Business activities of the information institute)
Article 43-2 (Revocation of permission for manufacturing medical devices)
Article 43-3 (Guidance and supervision of the information institute)
Article 43-4 (Request for materials)
Article 43-5 (Investigator of causal relations)
Article 43-6 (Purchasing insurance policies)
Article 44 (Delegation and entrustment of authority)
Article 44-2 (Legal fiction as public officials in application of penalty provisions)
Article 45 (Protection of submitted data)
Article 46 (Special cases on medical devices for animals)
Article 46-2 Deleted.
Article 47 (Succession to status of manufacturers and relevant matters)
Article 48 (Transfer of effects of administrative sanctions)
Article 49 (Renewal of manufacturing permission, etc.)
Article 50 (Fees)
CHAPTER VIII PENALTY PROVISIONS
Article 51 (Penalty provisions)
Article 52 (Penalty provisions)
Article 53 Deleted.
Article 53-2 (Penalty provisions)
Article 54 (Penalty provisions)
Article 54-2 (Penalty provisions)
Article 55 (Joint penalty provisions)
Article 56 (Administrative fines)
ADDENDA <Act No. 10564, Apr. 7, 2011>
ADDENDA <Act No. 11690, Mar. 23, 2013>
ADDENDA <Act No. 11985, Jul. 30, 2013>
ADDENDA <Act No. 11998, Aug. 6, 2013>
ADDENDA <Act No. 12107, Aug. 13, 2013>
ADDENDA <Act No. 12392, Jan. 28, 2014>
ADDENDA <Act No. 13116, Jan. 28, 2015>
ADDENDA <Act No. 13698, Dec. 29, 2015>
ADDENDA <Act No. 14330, Dec. 2, 2016>
ADDENDA <Act No. 15279, Dec. 19, 2017>
ADDENDA <Act No. 15486, Mar. 13, 2018>
ADDENDA <Act No. 15945, Dec. 11, 2018>
ADDENDA <Act No. 16402, Apr. 23, 2019>
ADDENDA <Act No. 16405, Dec. 30, 2019>
ADDENDA <Act No. 17007, Feb. 18, 2020>
ADDENDA <Act No. 17091, Mar. 24, 2020>
ADDENDA <Act No. 17248, Apr. 7, 2020>
ADDENDA <Act No. 17472, Aug. 11, 2020>
ADDENDA <Act No. 17922, Mar. 9, 2021>
ADDENDA <Act No. 17978, Mar. 23, 2021>
ADDENDA <Act No. 18319, Jul. 20, 2021>
ADDENDA <Act No. 18446, Aug. 17, 2021>
ADDENDA <Presidential Decree No. 19457, Jun. 13, 2023>
ADDENDA <Act No. 19608, Aug. 8, 2023>
ADDENDUM <Act No. 19655, Aug. 16, 2023>
ADDENDA <Act No. 20220, Feb. 6, 2024>
ADDENDUM <Act No. 20512, Oct. 22, 2024>
ADDENDUM <Act No. 20753, Jan. 31, 2025>
ADDENDUM <Act No. 20888, Apr. 1, 2025>