Dental Regulatory Free Zone Demonstration Preparation Meeting Held

On the 7th, the Ministry of SMEs and Startups announced that it held a preparatory meeting to commence the demonstration for the full-scale implementation of the 'Daegu Inno-Dental Regulatory Free Zone (Daegu Special Zone),' designated this year with the goal of creating an advanced dental industry ecosystem, at Kyungpook National University Dental Hospital in Daegu.

This meeting was held to establish a 'demonstration roadmap,' including demonstration goals, schedule, and safety verification plans, ahead of the full-scale demonstration. Participants included the Ministry of Environment, the regulatory authority; Korea Testing & Research Institute (KTR) and Korea Testing Laboratory (KTL), which support medical device clinical trials; the Office for Government Policy Coordination; and the Special Zone Ombudsman, to discuss effective regulatory relief measures.

The Daegu Special Zone plans to recycle medical waste under the Waste Management Act exemption, receiving about 3,000 donated teeth annually. These teeth will undergo processes to remove unnecessary organic matter and viruses, followed by production of bone graft material raw materials and medical device clinical trials. To ensure ethical recycling of teeth, business agreements have been signed with five dental hospitals, including Hanbit Dental Hospital in Ulsan. The dental hospitals will legally donate extracted teeth, and the Special Zone operators will establish a computerized system to manage de-identified donor information and tooth distribution volumes. Furthermore, in cooperation with the Ministry of Environment, the tooth recycling status will be managed in connection with the government waste management system.

Additionally, to ensure the safe recycling of teeth, the plan is to collaborate with Korea Testing & Research Institute, which possesses virus removal evaluation technology, as well as Korea Testing Laboratory and others, to conduct safety evaluations of the donated teeth and medical device clinical trials.

Ryu Sun-mi, Director of the Special Zone Operation Division at the Ministry of SMEs and Startups, stated, “Since tooth recycling is a world-first project, we will operate a public-private cooperation system throughout the entire demonstration process to ensure its successful implementation.”