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Manufacturer support program

기업지원 프로그램

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.


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)
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



a receipt of an application form and review in advance



face-to-face consultation



written evaluation






execution of selected tasks



progress check



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.



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