ASAN Medical Center Medical Device Clinical Trial Support Center

Support Services

We secure and support the clinical Safety and efficacy of artificial intelligence medical software,
medical robot, and medical devices.

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Manufacturer support program

Manufacturer support program?

As part of a project for the Ministry of Health and Welfare to foster the medical device R&D industry and establish a hospital-centered convergence and cooperation research platform, this program supports the manufacturers of medical information convergence automated devices in Korea with performance evaluation tests and costs for clinical trial and conducting research.

Fields

feasibility study / clinical trial

Support fields		Contents
feasibility study		Verification of safety and efficacy of prototype or complete product
Clinical trial in human	Pilot clinical trial	Evaluation of feasibility in early development (derive feedback on structure/form and clinical improvement through the use of medical staff)
Clinical trial in human	Pivotal clinical trial	Verification of safety and efficacy for medical device approval

※ Through the participation of the institution in advance, the research direction of the feasibility study and clinical trial must be set beforehand.
※ Support for feasibility study only is not available.

The target of support

Manufacturers in Korea promoting the commercialization of medical information convergence automated devices

※ ‘Medical information convergence automated device’ : Medical robot (used for diagnosis and treatment, including surgery/rehabilitation/nursing) and automated medical device, including medical devices using Artificial intelligence technology based on medical information such as medical Big data

Support contents

Cost support: Support the cost for performance evaluation test/clinical trial (according to the regulations of KHIDI (Korea Health Industry Development Institute))

Research support: Full support the development of clinical trial protocols if selected as a target for the corporate support program
Full support the tasks related to project management such as IRB Agency and monitoring within CRA work scope in research

Content and goals

Submit a report or evaluate oral presentation upon request for intermediate progress check (within 6 months)

Out of the total research expenses, the rest other than the expenses supported through this program must be paid in cash or in kind.

Final goal

Feasibility study: Performance test report, IACUC end report, publishing papers to international journals (SCI, SCIE) , etc.

Clinical trials: product license, IRB termination, and result report (CSR), publishing papers to international journals (SCI, SCIE), etc.

Evaluation procedure

STEP 01

a receipt of an application form and review in advance

STEP 02

face-to-face consultation

STEP 03

written evaluation

STEP 04

selection

STEP 05

execution of selected tasks

STEP 06

progress check

STEP 07

final report

Application Guide

How to apply: Online application after completing the application form and required documents

Documents for submission: other than the application form, upload scan files of documents

No	Documents for submission	Remark
1	Application form	Mandatory (scanned copy including representative seal must be added)
2	Certificate of Business Registration	Mandatory
3	Product description	Mandatory
4	MFDS license of the product	If applicable
5	Certificate of GMP	If applicable
6	Application form or report from an accredited testing institution	If applicable
7	MFDS approval letter for a clinical trial plan	If applicable
8	IRB/IACUC application or approval letter	If applicable

[Must read] Instruction on filling out and submitting the application form

If the selected corporate violated the announcement or false statement or intentional omission are found in the application form, the selection may be canceled and support fund may be returned.

The management of project performance under this program is follows the related laws of the Ministry of Health and Welfare and internal regulations of AMC CARE.

Inquiry

AMC CARE

+82-2 - 3010 - 8669 / care@amc.seoul.kr