[MDREX NEWSLETTER] Market Entry Considerations, including Product Approval and Reimbursement Listing, etc., ....

[MDREX NEWSLETTER] Market Entry Considerations, including...

2025. 4. 15.

MDREX NEWSLETTER

Market Entry Considerations, including Product Approval and Reimbursement Listing, etc., Following the MOHW’s Announcement of the 2025 Implementation Plan for the “National Health Insurance Comprehensive Plan”

April 15, 2025

On April 1, 2025, the Ministry of Health and Welfare (hereinafter “MOHW”) announced the 2025 Implementation Plan for the “National Health Insurance Comprehensive Plan,” which included directions for accelerating the market entry of innovative medical devices and improving the management system for medical materials. The key improvement measures and market entry considerations are summarized below.

1. Accelerated Market Entry of Innovative Medical Devices

- (By the first half of 2025) The scope of the Deferred nHTA System will be expanded from “non-invasive diagnostic technologies” to include “all non-invasive medical technologies.” Additionally, the deferral period will be extended from the current 2 years to a maximum of 4 years (2+2 years).

- (By the second half of 2025) Through regulatory reform, products approved by the Ministry of Food and Drug Safety (hereinafter “MFDS”) under the strengthened clinical evaluation track (e.g., Clinical Evaluation Reports, or CERs) will be granted immediate market entry (for 3 years), with the New Health Technology Assessment (nHTA) to be conducted at the time of reimbursement listing.

(Considerations) Although details of the relevant laws and administrative rules have yet to be released, the announced improvement to the Deferred nHTA System indicates that “all non-invasive medical technologies” classified as new health technologies, and supported by clinical trial data (meeting applicable criteria), may be used on a non-reimbursed basis for up to five years [= 2 years + 2-year extension + 1 year (nHTA period)].

Accordingly, for products incorporating digital technologies such as AI, it has become crucial to strategically generate clinical trial data that align with the Health Insurance Review and Assessment Service (hereinafter “HIRA”) standards for determining whether a technology is considered “existing or new.” This will increase the likelihood of being classified as a new health technology.

Furthermore, the MFDS announced that if any of the 140 product categories (to be designated) are approved through the strengthened clinical evaluation track (i.e., CER-based approval), a regulatory pathway will be provided for market entry without an nHTA for up to four years [= 3 years + 1-year nHTA period]. Therefore, for products that are ineligible for the Deferred nHTA System, utilizing this pathway may be a practical alternative for market entry.

However, unlike the Deferred nHTA System, for products that are newly designated as medical technologies and approved via the strengthened MFDS track, the government is expected to enforce usage and price controls.

2. Improvement of the Medical Materials Management System

- In response to rising production costs and challenges in securing a stable supply, the government plans to monitor the supply of medical materials required for severe and emergency medical care. For products identified as “in short supply,” the MOHW will revise the pricing system and establish response measures. For reference, eligible items will be limited to those designated by the MFDS as requiring production/import suspension reporting, or those classified as rare/essential materials upon request by medical societies or hospitals.

(Considerations) Due to reciprocal tariffs and the re-evaluation of medical materials, it is anticipated that for some reimbursed or selectively reimbursed materials imported from certain countries, company profit margins may decline under the current MRP (Maximum Reimbursement Price) structure, or supply shortages may occur.

As such, many companies are expected to consider forming task forces (TFs) under industry associations or cooperatives to address this issue. In particular, companies may seek to be designated as “items requiring production/import suspension reporting” or as “essential medical materials” in order to trigger price re-evaluation.

For reference, medical devices subject to production/import suspension reporting are defined as cases where the top three products account for 75% or more of the market, or a single product holds over 50% market share.

Additionally, in cases of rare or urgently needed imported medical devices, the MFDS-affiliated Korea Medical Device Safety Information Center may directly import/distribute products without prior marketing approval. In such cases, prices are determined not based on existing practice fees but instead reference the insurance or retail prices in the country of origin, in accordance with Table 4 of the MOHW Notification on the Determination and Adjustment Standards of Procedures/Materials.