Korean Jurisdictional Update

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Ⅲ

Ⅳ

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Ⅰ

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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

5

Capacity building for regulatory & technological expertise

Ⅱ

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『IVD Act』

Development of the draft &

Proposed enactment in Dec, 2017

Customized management

principles to reflect unique

characteristics of IVDs

7

Legal Foundation reflecting unique characteristics of IVDs

for Flexible Review & Approval System 8

Ⅲ

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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

Ⅳ

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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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