Statutes of the Republic of Korea

No. 15486
Promulgation Date 2018-03-13
Ministry of Food and Drug Safety

ALL

CHAPTER I GENERAL PROVISIONS

Article 1 (Purpose)

Article 2 (Definitions)

Article 2 (Definitions)

Article 3 (Classification and Designation of Classes)

Article 4 (Relationship with other Acts)

CHAPTER II MEDICAL DEVICES COMMITTEE

Article 5 (Medical Devices Committee)

CHAPTER III MANUFACTURING, ETC. OF MEDICAL DEVICES

Section 1 Manufacturing Business

Article 6 (Manufacturing Business Permission, etc.)

Article 6-2 (Matters to be Observed by Quality Managers and other Relevant Matters)

Article 6-3 (Restrictions on Manufacturing Permission, etc.)

Article 6-4 (Designation, etc. of Institutions Reviewing Technical Documents)

Article 7 (Conditional Permission, etc.)

Article 8 (Re-Examination of Newly Developed Medical Devices, etc.)

Article 9 (Re-Evaluation)

Article 10 (Approval, etc. of Clinical Test Plans)

Article 10-2 (Designation, etc. of Institutions Conducting Non-Clinical Trials)

Article 11 (Preliminary Examinations of Manufacturing Permission, Notification, etc.)

Article 12 (Permission, etc. for Change)

Article 13 (Obligations of Manufacturers)

Article 13-2 (Submission, etc. of Expense Reports on Details of Provision of Economic Profits, etc.)

Article 14 (Notification of Permanent Closure, Temporary Shutdown, etc.)

Section 2 Import Business

Article 15 (Import Business Permission, etc.)

Section 3 Repair Business

Article 16 (Notification on Repair Business)

Article 16 (Notification on Repair Business)

Section 4 Distribution Business and Leasing Business

Article 17 (Notification of Distribution Business, etc.)

Article 18 (Matters to be Observed by Distributors, etc.)

CHAPTER IV HANDLING, ETC. OF MEDICAL DEVICES

Section 1 Standards

Article 19 (Standard Specifications)

Section 2 Labeling and Advertisements

Article 20 (Labeling on Containers, etc.)

Article 20 (Labeling on Containers, etc.)

Article 21 (Labeling on Outer Package, etc.)

Article 22 (Labeling on Package Inserts)

Article 22 (Labeling on Package Inserts)

Article 23 (Requirements for Labeling)

Article 24 (Prohibition, etc. on Labeling and Advertisements)

Article 25 (Review of Advertisements)

Section 3 Handling

Article 26 (General Prohibitions)

Article 26 (General Prohibitions)

Article 27 (Testing and Inspections)

Article 28 (Designation, etc. of Quality Control Examination Agencies)

CHAPTER V CONTROL

Article 29 (Medical Devices Subject to Tracking and Control)

Article 30 (Preparation, Preservation, etc. of Records)

Article 31 (Control of Adverse Effects)

Article 31-2 (Reports, etc. on Details of Supply of Medical Devices)

Article 31-3 (Establishment, etc. of Integrated Medical Device Information System)

Article 31-4 (Designation and Operation, etc. of Integrated Medical Device Information Center)

CHAPTER VI SUPERVISION

Article 32 (Reporting, Inspection, etc.)

Article 33 (Inspection Orders)

Article 34 (Orders for Recall, Destruction, Public Announcement and Other Relevant Matters)

Article 35 (Orders for Suspension of Use, etc.)

Article 35-2 (Corrective Order)

Article 36 (Revocation of Permission, etc., Suspension of Business Activities, and Relevant Matters)

Article 36 (Revocation of Permission, etc., Suspension of Business Activities, and Relevant Matters)

Article 37 (Revocation of Designation, etc.)

Article 38 (Imposition of Penalty Surcharges)

Article 39 (Hearings)

Article 40 (Medical Device Surveillance Officers)

Article 40-2 (Customer Medical Device Surveillance Officers)

CHAPTER VII SUPPLEMENTARY PROVISIONS

Article 41 (Research and Development for Growth of Medical Device Industry)

Article 42 (Establishment of National Institute of Medical Device Safety Information)

Article 43 (Business Activities of the Information Institute)

Article 43-2 (Revocation of Certification or Notification)

Article 43-3 (Guidance, Supervision, etc. of the Information Institute)

Article 43-4 (Request for Materials)

Article 43-5 (Investigator of Causal Relations)

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 (Special Cases concerning Medical Devices in Cases of Infectious Disease Pandemic, etc.)

Article 47 (Succession to Status of Manufacturers, etc., and Relevant Matters)

Article 48 (Transfer of Effects of Administrative Sanctions)

Article 49 (Renewal of Permission, Notifications, etc.)

Article 50 (Fees)

CHAPTER VIII PENALTY PROVISIONS

Article 51 (Penalty Provisions)

Article 52 (Penalty Provisions)

Article 52 (Penalty Provisions)

Article 53 (Penalty Provisions)

Article 53-2 (Penalty Provisions)

Article 53-2 (Penalty Provisions)

Article 54 (Penalty Provisions)

Article 54-2 (Penalty Provisions)

Article 55 (Joint Penalty Provisions)

Article 56 (Administrative Fines)

Article 56 (Administrative Fines)

ADDENDA

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>