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[MDREX NEWSLETTER] Updates to the Sub-Regulation following Revisions of the Regulations on New Health Technology Assessment (Effective November 18, 2025)

작성자 MDREX 날짜 2025-11-26 17:32:22 조회수 17

Updates to the Sub-Regulation following Revisions of the Regulations on New Health Technology Assessment (Effective November 18, 2025)

September 26, 2025

The Ministry of Health and Welfare (MOHW) has updated all sub-regulations, including notifications and administrative guidelines related to the New Health Technology Assessment (nHTA) and Innovative Health Technology (IHT) programs, reflecting the amendments to the “Regulation on New Health Technology Assessment,” which will take effect on November 18, 2025.

These revisions bring significant changes—clarifying the operation of the Conditional Deferred nHTA Program, extending the permitted duration of IHT Program, and specifying committee operation procedures—that are likely to impact future market access strategies.

1. Amendments to the “Regulation on Procedures and Methods of New Health Technology Assessment” (MOHW Notification No. 2025-183)

Applications for Deferred nHTA Program may be rejected if the technology has already undergone nHTA; however, an exception has been newly added:
“Provided, this does not apply when the application has been made to add medical devices to the list under a health technology already eligible for deferred assessment.” (Article 3-4)
For non-invasive technologies that do not require clinical studies, utilization monitoring will be conducted by the Expert Committee on Innovative Health Technologies (Article 5-2).

2. Amendments to the “Regulation on the Evaluation and Implementation of Innovative Health Technologies” (MOHW Notification No. 2025-184)

The permitted use period for IHTs may now be extended once, allowing a maximum duration of up to 5 years (Articles 6-3, 7-4 to 7-6).
A new Innovation Committee has been established to review ongoing process management and compliance throughout the IHT utilization period (Article 7-1).

3. Amendments to the “Administrative Guidelines for the Operation of the nHTA Committee” (MOHW Administrative Rule No. 152)

To demonstrate safety and effectiveness, review materials may now include domestic or international clinical literature (Article 5-1-2).
Expert Committees may conduct opinion-hearing procedures and can evaluate not only on safety and effectiveness but also potential (future value) (Article 6).
Opinion-hearing request submission deadlines and opinion notification periods are now differentiated by program type and aligned with the actual operational workflow (Article 6-2, 6-3).
Detailed appeal procedures and methods have been provided in the guidelines (Article 6-3), and a new standardized Appeal Form has been added as Annex Form No. 2.

Key Implications for Medical Device Companies

To add a medical device to the list under a health technology eligible for deferred nHTA, companies must provide evidence demonstrating substantial equivalence to a technology already listed for deferred nHTA with regards to its structure, mechanism of action, performance, intended use, and method of use. Meeting this requirement will be crucial for a timely market entry and revenue growth.

Furthermore, to improve the validity and acceptability of appeals regarding the results of the new health technology assessment, it is essential to compile sufficient supporting evidence as required by regulations and present it within a clear, professionally structured argument.

MDREX provides a comprehensive end-to-end regulatory support throughout the entire process — substantial equivalence analysis, deferred nHTA strategy development, appeal dossier preparation, etc

If you require an impact analysis based on the amended regulations or need tailored strategies for a specific technology, please contact us at pro@mdrex.co.kr.

We are committed to supporting your successful market access and commercialization pathway into Korea.