Korea adopts immediate market entry system for innovative DTx, medical robots

The government will introduce the “Immediate Market Entry Medical Technology System” to reinvigorate innovative medical devices.

Under the system, medical devices that enter the market immediately will be evaluated after three years of use to determine whether they will receive health insurance benefits.

On Thursday, the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and the Office for Government Policy Coordination discussed ways to improve the market entry process for new medical devices and decided to introduce the system.

Safety and efficacy evaluations must be passed through the new medical technology evaluation system for new medical technology to enter the market. Therefore, even medical technologies using licensed medical devices could not be used before passing the evaluation process if they were not included in the existing health insurance list.

So, the Health and Welfare Ministry and the Food and Drug Safety Ministry have prepared the Immediate Market Entry Medical Technology System to support the rapid entry of new medical devices into the market while ensuring safety and reducing the burden on patients by improving the system that encompasses the entire process of medical device approval, new medical technology evaluation, and health insurance registration.

Under the new system, medical technologies that use medical devices eligible for immediate entry can be used immediately in the market for three years after medical device approval, with only a confirmation of the existing technology. They can enter the market within 80 to 140 days after approval.

The government plans to prioritize new and innovative medical devices with high independent use of medical devices in medical technology as medical devices eligible for immediate entry. In addition, the government plans to gradually expand the applicable items by reflecting the opinions of the industry while operating the system.

The government reviews more than 140 items, including seven digital therapeutics (DTx) devices, 37 in vitro diagnostic medical devices, 93 artificial intelligence diagnostic aids, and three medical robots.

To alleviate uncertainty and facilitate the immediate entry of technologies due to institutional improvements, the government will also provide preliminary consulting to help companies determine whether they have existing or new technologies and design clinical trials.

In addition, the procedures for medical device approval by the Ministry of Food and Drug Safety and confirmation of existing and new technologies by the Health Insurance Review and Assessment Service (HIRA) will be conducted simultaneously, if desired, to shorten the market entry period and simplify the process.

‘Enter the market first and withdraw later if problems are found’

Along with allowing immediate entry, safety verification will also be strengthened. At the approval stage, clinical evaluation will be improved by comprehensively analyzing clinical trials, experience, and literature in line with international standards, and approval will be granted by specifying the target disease and method of use.

The Ministry of Health and Welfare will also ensure the safety of the medical field use process. For instance, it will continuously monitor adverse events and accidents to ensure that companies and user organizations are required to report any problems, strengthen safety management by seeking patient consent before use, and enable patients to report adverse events directly.

If a technology item is judged to have a high level of risk through this process, it will be discontinued and removed from the market.

For technologies that have entered the market immediately through this process, a new medical technology evaluation will be conducted after three years. The comprehensive value of the technology will be categorized into grades, and the best technologies will be covered by health insurance.

The unreimbursed use of immediate entry technologies will be monitored semi-annually to identify and manage items of great clinical importance or high-cost burden.

If the monitoring results show that reducing patient burden is necessary, the ministry will conduct an early evaluation of new medical technologies and decide whether to cover them for health insurance even during the three-year immediate entry period, either by company application or ex officio.

“We will revise laws and guidelines as soon as possible and continue to collaborate with related organizations to implement improvement plans smoothly,” said Kim Kook-il, a healthcare policy officer at the Ministry of Health and Welfare.