The Ministry of Food and Drug Safety Leading 'Digital Healthcare Innovation'... Discussing Regulatory Improvement Directions Through Workshop

The Ministry of Food and Drug Safety announced that it will hold the ‘Digital Medical Products Regulatory Innovation Workshop’ on the 17th at SpaceShare Samsung COEX Center in Gangnam-gu, Seoul, with companies and associations (cooperatives) related to the digital medical products sector, including medical devices, pharmaceuticals, and wellness products.

Food and Drug Safety Ministry building exterior [Image source=Yonhap News]

This workshop is the first event to mark the full-scale activities of the ‘Digital Medical Products Regulatory Innovation Public-Private Joint Task Force,’ which was jointly formed by the Ministry of Food and Drug Safety and private organizations on the 31st of last month. In addition to the eight private organizations participating in the task force, including the Korea Medical Devices Industry Association, Korea Medical Devices Cooperative, Korea Venture Business Association, Korea Smart Healthcare Association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Digital Wellness Association, Korea Industrial Intelligence Association, and Korea Bio-Pharmaceutical Association, the event was prepared as a venue to explore regulatory innovation measures together with the Korea Medical Device Safety Information Center and the Advanced Medical Products Approval and Demonstration Research Institute.

At this event, attendees will share information on digital medical product-related legislation being promoted jointly by the National Assembly and the government, domestic and international regulatory systems, and corporate difficulties, and freely discuss directions for regulatory improvements to ensure the safety of digital medical products and the development of the industry. Specifically, in-depth discussions will be held on topics such as ▲classification of digital medical products ▲clinical trials and real-world evaluation ▲approval, quality management, excellent company certification, and cybersecurity of digital medical devices ▲professional software, labeling/advertising, and sales exceptions ▲clinical trials and approval of digital convergence pharmaceuticals ▲performance certification of digital medical and health support devices ▲support for the development of digital medical products.

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, encouraged the task force’s full-scale activities, stating, “In a rapidly changing environment such as technological advancement, the task force plays a significant role in improving public health through proactive regulatory innovation and creating an environment for the development of new-concept products that will lead the global market.” She added, “We will listen to the various opinions discussed at the workshop and work together with the public and private sectors to establish reasonable regulatory measures that can proactively respond to the changing times.”

This content was produced with the assistance of AI translation services.