Act On In Vitro Diagnostic Medical Devices
전체선택
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
Article 2 (Definitions)
Article 3 (Classification and Designation of Classes)
Article 4 (Relationship to Other Statutes)
CHAPTER II MANUFACTURING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Article 5 (Permission for Manufacturing Business)
Article 6 (Concurrent Review of Companion Diagnostic Medical Devices and Drugs)
Article 7 (Clinical Performance Study)
Article 8 (Clinical Performance Study Institutions)
Article 9 (Training for Persons Engaging in Clinical Performance Studies)
Article 10 (Permission for Modification)
Article 11 (Import Business Permission)
Article 12 (Certification of In Vitro Diagnostic Test in Clinical Laboratories)
CHAPTER III HANDLING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Article 13 (Labeling on Containers)
Article 14 (Labeling on Outside Package)
Article 15 (Labeling on Package Inserts)
CHAPTER IV MANAGEMENT AND SUPERVISION
Article 16 (Reporting and Inspection)
Article 17 (Inspection Order)
Article 18 (Revocation of Permission and Suspension of Business Affairs)
Article 19 (Revocation of Designation)
Article 20 (Imposition of Penalty Surcharges)
CHAPTER V SUPPLEMENTARY PROVISIONS
Article 21 (Committee of Experts on In Vitro Diagnostic Medical Devices)
Article 22 (Technical Support)
Article 23 (Promotion of Collection and Use of Information on In Vitro Diagnostic Medical Devices)
Article 24 (Manufacturing of Reference Standards for In Vitro Diagnostic Medical Devices)
Article 25 (Hearing)
Article 26 (Delegation and Entrustment of Authority)
Article 27 (Legal Fiction as Public Officials in Application of Penalty Provisions)
Article 28 (Special Cases concerning In Vitro Diagnostic Medical Devices for Animals)
CHAPTER VI PENALTY PROVISIONS
Article 29 (Penalty Provisions)
Article 30 (Penalty Provisions)
Article 31 (Penalty Provisions)
Article 32 (Joint Penalty Provisions)
Article 33 (Administrative Fines)
ADDENDA