Korea Health Industry Development Institute Announces Recruitment for Digital Health Innovative Medical Device Demonstration Support Project

[Asia Economy Reporter Lee Chun-hee] The Korea Health Industry Development Institute announced on the 22nd that it will begin recruiting participating organizations for the Digital Healthcare Medical Device Demonstration Support Project.

Recently, digital health medical devices have seen accelerated research and development (R&D) and regulatory approval processes. However, even after obtaining approval from the Ministry of Food and Drug Safety, final commercialization requires clinical evidence from the field to proceed with new medical technology assessments and National Health Insurance registration.

Accordingly, the government recently announced regulatory improvement measures in July to allow the use of artificial intelligence (AI) and digital innovative medical devices (non-invasive) after approval, as well as to shorten evaluation periods.

As part of this policy announcement, the institute plans to support pilot distribution to medical institutions and clinical design for digital health medical devices (software) linked with regional (Daegu) infrastructure through this project.

Additionally, the institute will establish a cooperative system with related organizations such as the Korea Institute for Health and Social Affairs, a specialized institution for new medical technology assessment, to provide comprehensive consultation from clinical design to pilot distribution (demonstration) for the selected products through this announcement, focusing on creating evidence for new medical technology evaluation and insurance registration.

The detailed support contents of the project announcement consist of two parts: ▲clinical design for digital healthcare medical devices ▲pilot distribution of digital healthcare medical devices to medical institutions.

Clinical design support will assist in developing clinical protocols necessary for pilot distribution. Up to 100 million KRW per project per year will be supported. Up to 10 projects will be selected this year, and depending on the evaluation results, a second-stage clinical demonstration project will be linked and supported next year.

Support for pilot distribution to medical institutions will provide evidence of actual use through pilot distribution of products approved by the Ministry of Food and Drug Safety. This year, up to 500 million KRW per institution will be supported for two medical institutions, and additional support will be provided depending on whether the period is extended. Selected medical institutions must pilot distribute at least two products annually (supporting product purchase costs) and secure evidence of actual use.

The recruitment for participating organizations will be held from the 22nd until the 5th of next month. More detailed information can be found on the Medical Device Industry Comprehensive Information System or the Daegu-Gyeongbuk Advanced Medical Industry Promotion Foundation website.

Hwang Sung-eun, head of the Medical Device and Cosmetics Industry Division at the institute, said, “Through this project, we will expand the region-based clinical demonstration infrastructure in the digital health field,” adding, “We will actively support the commercialization of innovative medical devices.”

This content was produced with the assistance of AI translation services.