No. 20139
Promulgation Date 2024-01-23
Ministry of Food and Drug Safety
ALL
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
Article 2 (Definitions)
Article 3 (Classification and designation of product classes)
Article 4 (Responsibilities of the State)
Article 5 (Relationship to other statutes)
CHAPTER II FORMULATION OF COMPREHENSIVE SAFETY MANAGEMENT PLANS
Article 6 (Comprehensive safety management plan for digital medical products)
Article 7 (Advisory on digital medical products)
CHAPTER III DIGITAL MEDICAL DEVICES
SECTION 1 Manufacture and Import of Digital Medical Devices
Article 8 (Manufacturing business permission for digital medical devices)
Article 9 (Approval of clinical study protocols)
Article 10 (Approval of clinical performance study protocol)
Article 11 (Permission for change)
Article 12 (Import business permission for digital medical devices)
Article 13 (Matters to be observed by manufacturers of digital medical devices and importers of digital medical devices)
Article 14 (Measures for protection from electronic intrusion)
Article 15 (Real-world assessment)
Article 16 (Certification of good management system)
Article 17 (Application for and assessment of certification of good management system)
Article 18 (Preferential treatment for manufacturers, etc. of digital medical devices who have obtained certification of good management system)
Article 19 (Revocation of certification of good management system)
Article 20 (Digital medical device repair business)
SECTION 2 digital medical device software
Article 21 (digital medical device software for professional use only)
Article 22 (Matters to be Stated in Digital Medical Device Software)
Article 23 (Advertisement of digital medical device software)
Article 24 (Certification of compliance with quality management standards for digital medical device software)
Article 25 (Confirmation and inspection of certification of compliance)
Article 26 (Entrustment of maintenance and management of digital medical device software)
Article 27 (Special cases concerning distribution of software as a medical device)
Article 28 (Partial exclusion from application of the Medical Devices Act to software as a medical device)
CHAPTER IV DIGITAL CONVERGENCE DRUG
Article 29 (Manufacturing business permission for digital convergence drugs)
Article 30 (Permission for import of digital convergence drugs)
Article 31 (Clinical study of digital convergence drugs)
Article 32 (Application of measures to protect digital medical devices constituting part of digital convergence drugs from electronic intrusion)
CHAPTER V DIGITAL MEDICAL OR HEALTH SUPPORT DEVICES
Article 33 (Notification of manufacture or importation of digital medical or health support devices)
Article 34 (Performance certification of digital medical or health support devices)
Article 35 (Distribution management of digital medical or health support devices)
CHAPTER VI ESTABLISHMENT OF FOUNDATION FOR DEVELOPMENT OF DIGITAL MEDICAL PRODUCTS
Article 36 (Performance of digital-based service)
Article 37 (Impact assessment of digital medical products)
Article 38 (Request for review of health insurance benefits)
Article 39 (Preliminary review of permission and notification)
Article 40 (Performance assessment of components of digital medical products)
Article 41 (Support for development of digital medical products and protection of intellectual property rights)
Article 42 (Support for research and development and standardization)
Article 43 (Training of specialized human resources)
Article 44 (International cooperation)
Article 45 (Regulatory support center for digital medical products)
Article 46 (Support for use of patient-specific digital medical products)
Article 47 (Establishment of organizations)
Article 48 (Designation of agency for certification affairs)
CHAPTER VII MANAGEMENT AND SUPERVISION
Article 49 (Reporting and inspection)
Article 50 (Suspension of business)
CHAPTER VIII SUPPLEMENTARY PROVISIONS
Article 51 (Disclosure of examination results)
Article 52 (Fees)
Article 53 (Hearings)
Article 54 (Delegation and entrustment of authority)
Article 55 (Legal fiction as public officials for purposes of applying penalty provisions)
CHAPTER IX PENALTY PROVISIONS
Article 56 (Penalty provisions)
Article 57 (Penalty provisions)
Article 58 (Penalty provisions)
Article 59 (Penalty provisions)
Article 60 (Joint penalty provisions)
Article 61 (Administrative fines)
ADDENDA <Act No. 20139, Jan. 23, 2024>