Korean Jurisdictional Update...Korean Jurisdictional Update Ⅰ Ⅱ Ⅲ Ⅳ 2 Ⅰ 3 4 『Special Act...
Transcript of Korean Jurisdictional Update...Korean Jurisdictional Update Ⅰ Ⅱ Ⅲ Ⅳ 2 Ⅰ 3 4 『Special Act...
Korean Jurisdictional Update
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『Special Act for Innovative Devices』
Development of the draft &
Proposed enactment in Dec, 2017
Promotion of international cooperative activities
2) Safety and performance
4) Technical docs & clinical data
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Capacity building for regulatory & technological expertise
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『IVD Act』
Development of the draft &
Proposed enactment in Dec, 2017
Customized management
principles to reflect unique
characteristics of IVDs
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Legal Foundation reflecting unique characteristics of IVDs
for Flexible Review & Approval System 8
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Manufacturer Wholesale Retail Medical
institutions
MD Information
Integration System
(UDI SYSTEM, DB)
Public MD
handlers MFDS Medical
institutions
Relevant
government agencies
Product info (UDI-DI related info)
Health insurance
management system
Customs clearance
system for MD
system link
provided
delivery info
MDITAC* assigned to manage the UDI system
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Development of related guidelines and reference literatures
Help desk service on the UDI System
*MDITAC: Medical Device Information Technology Assistance Center, an MFDS-affiliated public organization
- Analysis, process and provision of the collected data, based on UDI
Requirements for UDI placement & UDI registration
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『Guideline on Review & Approval for 3D-printed Personalized Orthopedic Implantable Devices』
『Guideline on Review & Approval for 3D-printed Personalized Dental Implantable Devices』
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『 Guideline on Review & Approval for Rehabilitation Robots 』
『 Guideline on Review & Approval for Big Data & AI-applied Medical Devices 』
『 Guideline on Clinical Evaluation of Validity for Artificial Intelligence(AI) Medical Devices 』
『 Guideline on Cancers, Genetic Disorders and Congenital Anomaly Test on Fetus as per
Testing Types of NGS Clinical Laboratories 』
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