OBJECTIVES: The purpose of the study is to share an effective policy to ensure innovative medical devices(IMD) to be used swiftly at the medical field.

METHODS: This study focused on the Integrated Review and Assessment System(IRAS) implemented in October 2022 for IMD to be put in place quickly to the medical field.

RESULTS: Before the amendment, it took around 390 days for IMD to be applied at the medical field as the review process for each department and institution. The designation of IMD, authorization of medical devices, screening the application for confirmation on existing or new health technology, innovative medical technology evaluation was carried out sequentially and individually. However, in accordance with the government's bio-health industry innovation plan announced in 2022 and the request of industrial circles, it was necessary to shorten the evaluation period. Accordingly, relevant ministries and related organizations introduced the IRAS so that it would be possible to review and evaluate innovativeness and safety simultaneously and comprehensively, in a way to enable IMD to quickly enter the medical field in 80 days. Health Insurance Review and Assessment Service(HIRA) established the Committee, which was a ground work for the IRAS, reflecting the characteristics of innovative technology and strengthening the professionalism. And, HIRA revised the Guidelines expanded the scope of acknowledgment of innovation. Through the IRAS, 3 products were designated as IMD for the first time on December 15, 2022. After the authorization of a medical device, it can be used for 3 to 5 years at a medical site as a non-covered benefit.

CONCLUSIONS: The IRAS allows IMD to enter the healthcare field as swiftly as possible. It helps medical device industry compensated for their innovative value and the patients have a wide range of choices and easy access to the innovative diagnostic and therapeutic services.