Amendment to Expand the Scope of the Deferred nHTA System – Advance Notice of Rule Revisions by the MOHW and MFDS
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On April 30, 2025, the Ministry of Health and Welfare ("MOHW") and the Ministry of Food and Drug Safety ("MFDS") jointly issued an advance notice of partial amendments to the "Regulations on the New Health Technologies Assessment" and the "Regulations on Medical Device Approval/Notification/Review." The core purpose of these amendments is to expand both the scope and procedures of the Deferred nHTA System, thereby enabling a broader range of innovative medical technologies to be used on a non-reimbursed basis immediately after market entry, which shall be referred to as the "immediate-market-entry scheme". Key details are as follows.
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- As previously introduced in the MDREX newsletter, the immediate-market-entry scheme would only be available to medical devices that are categorized as one of 140 MFDS designated target product categories and be approved by the MFDS based on Clinical Evaluation Reports (CERs) ("Applicable Technology").
- The list of 140 target product categories is expected to be officially announced on the MFDS website and may be further expanded in consultation with the MOHW.
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Eligibility Requirements for Immediate-Market-Entry Scheme
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- When submitting the product approval application to the MFDS for an Applicable Technology, the applicant must indicate in the remarks section that the product is "eligible for Deferred nHTA as a medical device applying for approval/certification based on CER" and must submit the relevant CER materials.
- If the device is approved by MFDS and the related medical technology is subsequently determined by the Health Insurance Review and Assessment Service ("HIRA") to be a "new technology" (i.e., not an existing one), it will be allowed to be used on a non-reimbursed basis for up to 3 years without undergoing the nHTA.
※ This is a separate scheme from the existing Deferred nHTA System (2+2 years).
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- Clinical evaluation materials submitted to MFDS must include not only clinical trial data of the product but also clinical experience and literature-based data (e.g., systematic literature reviews).
- However, such data may not be sufficiently available for many novel health technologies; therefore, preparing appropriate responses to Requests for Information (RFIs) during MFDS review has become increasingly critical.
- MFDS is also expected to issue new guidelines on the generation of clinical evaluation data in the near future.
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Simplified Designation Procedure
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- Previously, the eligibility for the Deferred nHTA System was determined by the National Evidence-based Healthcare Collaborating Agency ("NECA"). Under the immediate-market-entry scheme, eligibility will be determined based solely on MFDS’s product approval (with CER) and HIRA’s new technology determination, without NECA’s involvement.
※ Parallel submission and review is permitted.
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This amendment of the rule represents a significant policy advancement in facilitating the early adoption and market access of innovative medical technologies.
It is crucial to prepare high-quality clinical evaluation data and to develop
a robust strategy for determining whether the technology qualifies as "existing or new." For professional consulting support in this process,
please contact MDREX at pro@mdrex.co.kr
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