MFDS Leads Digital Medical Regulation Innovation... Holds Meeting with Association and Organization Heads

On the 27th, the Ministry of Food and Drug Safety announced that it held a meeting on major policies in the medical device sector, including the enactment of laws related to the 'Digital Medical Products Act,' together with organizations involved in medical device manufacturing, import, distribution, and technical document review.

At the meeting of heads of medical device associations for regulatory innovation of digital medical products held on the 27th, participants are taking a commemorative photo. [Photo by Ministry of Food and Drug Safety]

At this meeting held with the Venture Business Association, Korea Medical Devices Industry Association, Korea Medical Devices Distribution Association, Korea Conformity Laboratories, and others, the Ministry of Food and Drug Safety explained the necessity of enacting the Digital Medical Products Act and shared the recognition with related organizations that prompt legislation of related laws is needed in the digital era.

Yu Cheol-wook, President of the Korea Medical Devices Industry Association, stated, “Digital medical devices such as software have limitations under the traditional medical device regulatory system, so it is necessary to establish a safety management and regulatory support system specialized for digital medical products.” He added, “The industry is very encouraged and has high expectations that the Ministry of Food and Drug Safety is promoting the enactment of related laws to understand new product development trends and implement scientific regulation.”

Song Seung-jae, Chairman of the Digital Healthcare Policy Committee of the Venture Business Association, also said, “The regulatory innovation by the Ministry of Food and Drug Safety helps the industry by proactively presenting evaluation criteria for the safety and performance of digital medical devices under development, facilitating rapid market entry and greatly contributing to strengthening international competitiveness.” He emphasized, “In particular, the prompt establishment of a management system for digital medical products and the urgent enactment of the Digital Medical Products Act currently underway are essential to revitalize domestic digital medical devices and expand exports.” He added, “The government and major medical device organizations will collaborate actively to support the enactment of the law and the securing of practical infrastructure accordingly.”

Furthermore, related organizations also actively welcomed Regulatory Reform 2.0. Meanwhile, regarding the task of reporting supply details focused on high-risk medical devices and health insurance-covered therapeutic materials, Shin Dong-jin, President of the Korea Medical Devices Distribution Association, said, “We will actively participate by conducting education and promotion targeting member companies to ensure the system can be stably and quickly established.”

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