The Biohealth Innovation Committee under the prime minister held its eighth meeting at the Seoul Government Complex on the 30th and said it would overhaul five "killer regulations" that block the development of the biohealth industry. The improvements were selected from among 337 tasks identified at the Regulatory Reform Plaza after review by relevant ministries.
First, it will ease the reporting obligations and implementation requirements of the early-entry system for innovative medical technologies (medical devices). The early-entry system for innovative medical technologies allows market entry and clinical use in the field for advanced technologies with potential value even before they undergo the new medical technology assessment.
Previously, many noted that the reporting obligations and implementation requirements were so strict that it was hard to use the system. The government partially accepted these views and plans to relax the requirements so new technologies can be applied more widely in clinical settings.
For example, going forward, corporations will be required to submit less in their reports to the Ministry of Health and Welfare, and the reporting interval will be lengthened. Reflecting actual use in hospitals, the system's conditions will be lowered to the minimum. The mandatory pre-use notification procedure will be eliminated, and the submission materials will be reduced, with the aim of finalizing the system improvement plan by Oct.
The procedure for changing patient consent forms under the early-entry system for innovative medical technologies will also be streamlined. Up to now, even minor edits to the standard form required renewed approval. Going forward, only major changes will need prior approval, reducing unnecessary administrative burdens in clinical settings.
The reasons for extending the grace period for the new medical technology assessment will be disclosed. The committee said that because the criteria for extension decisions have been opaque, corporations have found it hard to plan clinical studies, but going forward it will disclose the calculation grounds to improve predictability.
Inspections and checks under the grace system for the new medical technology assessment will also be strengthened. As corporations subject to the system have repeatedly engaged in promotion or sales outside the rules, the government will expand on-site inspections and sanctions to enhance patient safety and trust in the system.
The format for entering addresses on English-language certificates required for exporting medical devices will also be improved. Because the address listed on the Ministry of Food and Drug Safety license has differed from addresses on overseas approval documents, exporters have faced difficulties; going forward, the headquarters address will be clearly stated to streamline overseas certification procedures.
Vice Chair Kim Young-tae (Seoul National University Hospital director) said, "We will overhaul the regulations that have been the heaviest burden in the field so that corporations can apply innovative technologies to patients more quickly," and added, "We will transparently disclose regulatory reform outcomes and continue to drive institutional innovation across new industries such as AI, data, and R&D."
Launched in Dec. 2023, the Biohealth Innovation Committee has held eight meetings in total so far. In Apr. last year, it set up the Regulatory Reform Plaza under the committee and, through roundtables with associations and groups and the Regulatory Reform Task Force (on-site corporate consultations), identified 337 regulatory improvement tasks; excluding simple civil petitions and overlaps, it accepted 282 tasks, designated 222 as management tasks, and has been continuously checking on improvements.