Innovative medical devices at an international level will be approved and made available for immediate use in the field. The time to enter the market is expected to be cut from a maximum of 490 days to a minimum of 80 days.
The Ministry of Health and Welfare and the Ministery of Food and Drug Safety said on the 26th they will implement a system allowing medical technologies to enter the market immediately. They revised the rules on the evaluation of new medical technologies and the notice on medical device approval, notification, and review.
Currently, medical devices with new technologies must obtain approval from the Ministery of Food and Drug Safety and undergo a new medical technology evaluation. Introduced in 2007, the system evaluates technological safety and effectiveness. While the new medical technology evaluation can be deferred, there have been opinions that the procedures are complex and the evaluation takes a long time.
Going forward, new medical devices that have undergone international-level clinical trials at the approval stage of the Ministery of Food and Drug Safety will be able to enter the market immediately. The time it took from authorization to use in the field will be shortened. Digital medical devices using artificial intelligence (AI), in vitro diagnostic medical devices, and medical robots are eligible.
Even if they enter the market immediately, when necessary, the Minister of the Ministry of Health and Welfare may, by authority, conduct a new medical technology evaluation to decide whether national health insurance coverage applies. This is to prevent overuse of noncovered services and ease the burden on patients. Unsafe medical technologies will be removed from the market.
Gwak Sun-heon, health care policy director at the Ministry of Health and Welfare, said, "We will streamline market entry procedures to revitalize the medical device industry." Lee Nam-hee, director general of medical device safety at the Ministery of Food and Drug Safety, said, "It will be possible to provide treatment opportunities to patients who need new medical technologies."