Ministry of Health and Welfare Announces Amendment to 'Regulations on New Health Technology Assessment'
Establishes Criteria and Procedures for 'Immediate Market Entry Medical Technology'
Technologies with High Patient Need or Cost Burden Subject to Mandatory Assessment and Insurance Listing
New medical devices that incorporate advanced technologies?such as digital therapeutics, artificial intelligence (AI)-powered diagnostic support devices, in vitro diagnostic devices, and medical robots?will soon be able to be used directly in clinical settings without undergoing the 'New Health Technology Assessment.' This measure reflects concerns that the time required for market entry has been excessively long compared to the rapid pace of technological advancement in medical devices.
Foreign buyers are examining medical devices at the '2024 MediExpo Korea,' which opened on June 21 last year at EXCO in Buk-gu, Daegu. Photo by Yonhap News
The Ministry of Health and Welfare announced on April 30 that it will pre-announce a partial amendment to the 'Regulations on New Health Technology Assessment' until June 9, which will allow new medical devices to enter the market immediately without a separate assessment.
The New Health Technology Assessment is a mandatory procedure for new medical technologies to enter the market. New technologies must be verified for safety and efficacy before they can be used in clinical practice. Although measures such as the deferral system for new health technology assessment have been introduced to vitalize the medical device industry and enable early market entry of outstanding technologies, the procedures have remained complex and time-consuming, making it difficult to utilize excellent medical technologies at an early stage.
In response, the Ministry of Health and Welfare, together with the Ministry of Food and Drug Safety, announced the introduction of the 'Immediate Market Entry Medical Technology' system in November last year. The ministries have prepared institutional improvements so that medical technologies using new medical devices, which have undergone internationally strengthened clinical evaluations at the approval stage by the Ministry of Food and Drug Safety, can be used immediately without a separate new health technology assessment.
This amendment first defines the scope of medical technologies eligible for immediate market entry (those subject to assessment deferral). It applies to medical technologies that use new devices officially announced as new items through consultation between the Ministry of Food and Drug Safety and the Ministry of Health and Welfare at the approval stage, and that have undergone enhanced clinical evaluation.
Applicants seeking to defer the new health technology assessment must confirm with the Health Insurance Review and Assessment Service whether the medical technology already exists. If it is confirmed as a new technology, it can be used in clinical settings as a non-reimbursed service for three years without a separate assessment process. Afterward, the technology will be considered for inclusion in health insurance coverage, taking into account its clinical necessity and cost-effectiveness.
To prevent the abuse of non-reimbursed services and reduce patient burden during the use of immediately introduced medical technologies, the Minister of Health and Welfare may, if necessary, conduct a new health technology assessment and determine health insurance coverage status even during the immediate use period.
To address safety concerns arising from shortened market entry procedures, the government will strengthen the approval process by the Ministry of Food and Drug Safety, requiring internationally recognized clinical evaluations at the time of approval and specifying the target users and intended purposes. Technologies that present risks of adverse effects or patient accidents will be eliminated from use through a removal mechanism.
Along with the Ministry of Health and Welfare's amendment, the Ministry of Food and Drug Safety will also revise the 'Regulations on Medical Device Approval, Notification, and Review,' specifying the procedures for announcing medical devices eligible for immediate market entry and establishing detailed standards for clinical evaluations to strengthen safety verification.
Kim Kukil, Director of Health and Medical Policy at the Ministry of Health and Welfare, stated, "We have introduced the 'Immediate Market Entry Medical Technology System' to simplify the market entry procedures for new medical devices, thereby supporting industry revitalization and the early adoption of outstanding medical devices. We will continue to cooperate with relevant agencies to ensure that technologies with safety issues are removed from the market, monitor the use of non-reimbursed services to alleviate patient burden, and ensure that the new system is stably established and operated in clinical settings."
Opinions regarding the amendment can be submitted to the Medical Resources Policy Division of the Ministry of Health and Welfare until June 9. Detailed information is available on the Ministry of Health and Welfare website → Information → Laws and Regulations → Legislative and Administrative Notice Electronic Public Hearing.
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