The Korean government is taking action to address regulatory bottlenecks that have made it difficult for rapidly evolving medical technologies to reach clinical settings in a timely manner.
The Ministry of Health and Welfare (MOHW) announced Wednesday it will begin a legislative notice period through June 9 for a partial amendment to the Enforcement Rules on the Evaluation of New Medical Technologies. The revision outlines the procedures and criteria for the new "Immediate Market Entry Medical Technology" system.
The new system stems from a decision made during the Cabinet Meeting on State Affairs in November 2024, where officials agreed to establish a new regulatory pathway that would enable the early introduction of innovative medical technologies while maintaining safety and reducing patient burden.
All new medical technologies currently must undergo a formal evaluation process to verify their safety and efficacy before they can be used in clinical practice. Although the government has made efforts to ease these requirements through temporary evaluation deferrals, the industry has continued to raise concerns over the complexity and time required under the existing system.
To address these delays, the MOHW, in cooperation with the Ministry of Food and Drug Safety (MFDS), launched the Immediate Market Entry Medical Technology initiative in November 2024.
Under the initiative, technologies that use newly approved medical devices—already subject to internationally harmonized and strengthened clinical evaluations during the MFDS approval phase—can enter the market as an uninsured product without undergoing an additional assessment by the MOHW.
The proposed amendment clarifies that eligible technologies must involve devices officially designated as “new items” by the MFDS following consultation with the MOHW. These devices must also have undergone enhanced clinical evaluation procedures at the time of regulatory approval.
Applicants may submit a request to the Health Insurance Review and Assessment Service (HIRA) to determine whether their medical technology is based on an existing one. If it is deemed a novel technology, the product can enter the market immediately without further evaluation.
The reform also introduces a legal basis for the Minister of Health and Welfare to initiate a formal evaluation during the non-reimbursement period if concerns arise regarding safety risks or misuse of non-reimbursed services. The MOHW will be able to determine insurance coverage eligibility when deemed necessary to protect patients and control excessive medical costs.
The MOHW plans to initially apply the new system to highly innovative items that are used independently within medical procedures. It also aims to gradually expand the scope of eligible technologies.
After three years of implementation, the ministry will review the clinical necessity and cost-effectiveness of the technologies to determine their inclusion in the national health insurance reimbursement list.
To support the rollout, the MFDS will revise its “Regulations on Medical Device Licensing, Notification, and Review” to define procedures for announcing eligible medical devices and set detailed clinical evaluation criteria to reinforce safety verification.
“The introduction of the Immediate Market Entry Medical Technology system aims to revitalize the industry and facilitate earlier adoption of high-quality medical innovations by simplifying the regulatory process,” said Kim Guk-il, a senior official of the MOHW. “We will continue to work closely with relevant agencies to ensure that this new system is safely and effectively integrated into clinical practice, including the removal of technologies with safety issues and monitoring the use of non-reimbursed procedures to reduce patient burden.”