Today's medical devices have evolved beyond mere hospital equipment and instruments to become a sturdy pillar safeguarding the healthy daily lives of citizens. They have also established themselves as a next-generation core driver of Korea's future growth. While medicine in the past focused on "post-event response," concentrating on treatment after disease occurred, today's paradigm is shifting toward "human-centered customized care" that predicts and prevents disease based on cutting-edge technology. At the center of this transformation stand innovative medical devices.
Recently, as advanced digital technologies such as artificial intelligence (AI), virtual reality (VR), and big data have organically converged with medical devices, our daily lives are also changing. Health management that was previously possible only at hospitals is now possible through the use of digital medical devices in everyday life. Digital medical devices have made continuous health management possible anytime, anywhere, filling gaps in medical care and helping patients take the initiative in managing their lives and diseases.
Digital medical devices are already deeply embedded in our daily lives. A representative example is software that analyzes blood glucose values collected through continuous glucose monitors using AI algorithms to predict future levels and assist with customized management. Diabetes patients, who once had to endure the pain of pricking their fingertips with needles several times a day, now need only use a single patch. Through the patch, they can check real-time blood glucose changes and enjoy a "free daily life" by adjusting their diets on their own. Software medical devices that analyze heart rate information collected through smartwatches to provide advance warnings of potential hypertension, or that improve depressive symptoms through VR-based cognitive behavioral therapy, are likewise transforming everyday life.
Innovation is also taking place in clinical settings. Medical imaging interpretation assistance systems utilizing AI technology enhance physicians' diagnostic accuracy and reduce reading time, helping patients receive treatment as quickly as possible. Rehabilitation devices using VR support patients in continuing rehabilitation training on their own at home, freed from the burdens of hospital stays. In this way, digital medical devices effectively reduce the workload of medical staff and serve as valuable enablers in realizing patient-centered customized healthcare.
Backed by these innovative technologies, Korea's medical device industry is achieving remarkable growth in the global market. Last year, Korea's medical device production reached 12.3558 trillion won, with exports of 7.6395 trillion won. Imports stood at 7.1606 trillion won, achieving a trade surplus of 478.9 billion won. This marks a record of "five consecutive years of surplus." This is a valuable achievement made possible by Korean companies' relentless research and development (R&D). K-medical devices have now moved beyond simple price competitiveness to be proudly recognized as "first movers" even in the world's leading medical countries, taking the lead in setting global medical standards.
To accelerate the development of this medical device industry and dramatically expand citizens' treatment opportunities, the government plans to begin full implementation of approval and review innovation measures starting next month. Departing from the previous practice of sequentially reviewing vast amounts of data with limited personnel, specialized review teams in each field will now conduct parallel reviews simultaneously. This is expected to verify safety even more meticulously while raising review speeds to world-class levels. Through this, the time for innovative products to enter the market will be significantly shortened. The government also plans to operate channels for close communication with companies before and after approval applications to further enhance the predictability of approval reviews and reduce trial and error in the field.
The 29th of this month also marks the 19th "Medical Device Day." This year is the second anniversary since the day was officially designated as a national commemorative day. It is all the more meaningful that the industry, academia, and government can together envision the future of Korea's medical devices, which are growing rapidly in convergence with cutting-edge technology. The ultimate future that K-medical devices will create is a world in which citizens enjoy "healthier and happier lives." So that K-medical devices may warmly safeguard the daily lives of citizens and further lead the global market, the Ministry of Food and Drug Safety plans to pursue a major transformation into a regulatory service agency. Through this, it will always be the most reliable supporter of the people. At the same time, we will tear down regulatory barriers in the field so that our medical device industry can continue tireless and sustainable growth. We will fulfill our responsibility to the end so that all citizens can fully enjoy the benefits of cutting-edge medical devices whose safety has been verified.
