엠디웍스코리아

New Health Technology Assessment

The program covers internal medicine, surgery, procedures, examinations, and similar services. Based on a "systematic literature review" methodology in which the National Evidence-based Healthcare Collaborating Agency (NECA) comprehensively searches, analyzes, and synthesizes existing research, the New Health Technology Assessment Committee and specialized (sub)committees review the safety and effectiveness of the technology.

Technologies subject to assessment

• ① Medical technologies whose safety and effectiveness have not been assessed, where the Minister of Health and Welfare determines that assessment is necessary
• ② Medical technologies for which the purpose of use, target population, or procedure method, etc., of a technology already assessed as a new health technology have been changed, where the Minister of Health and Welfare determines that assessment is necessary

Source: Medical Service Act Article 53 (Assessment of new medical technologies) and Rules on New Health Technology Assessment Article 2 (Scope of new health technology assessment, etc.)

Applying for new health technology assessment

• After MFDS import product approval (certification/notification) is complete: apply for new health technology assessment after obtaining confirmation from the Health Insurance Review & Assessment Service (HIRA) on benefit coverage, non-covered status, and whether the technology is an existing technology
• Concurrent MFDS import product approval: apply through the one-stop service / integrated processing pathway

New health technology assessment procedure

Assessment of restricted medical technologies

For research-stage medical technologies that, following new health technology assessment, are confirmed to be safe and require rapid clinical introduction—technologies publicly notified on the restricted medical technology list under Article 3(11)(2) of the Rules on New Health Technology Assessment—this system allows clinical use for a specified period at institutions designated by the Minister of Health and Welfare, collects and analyzes the results, and creates opportunities to build clinical evidence.

Deferral of new health technology assessment

This system permits early market entry for medical technologies using medical devices (including in vitro diagnostic devices) approved through MFDS clinical trials that meet deferral criteria, and defers new health technology assessment for two years.

* You must file an application for new health technology assessment at least 30 days before the deferral period ends.

Innovative medical technology assessment

This system offers an opportunity for clinical use of innovative medical technologies whose safety is accepted but for whom effectiveness evidence is insufficient, by evaluating and recognizing their potential (potential value). Conditional use in clinical practice for a limited period of three to five years is permitted only when conditions publicly notified by the Minister of Health and Welfare—such as period of use, purpose, target population, and procedure (examination) method—are met. After the use period ends, re-evaluation based on evidence accumulated in clinical practice is required to demonstrate effectiveness.