Korea's Ministry of Food and Drug Safety (MFDS) is launching intensive inspections on key medical devices including contact lenses, whose usage increases during summer, as well as automated external defibrillators. The agency explained it is taking preemptive measures to strengthen safety management, reflecting seasonal usage patterns and medical field demand.
MFDS announced Tuesday that it will conduct second-quarter medical device collection and inspection this year jointly with six regional food and drug safety offices nationwide. As part of its regular quarterly inspections, the agency has selected inspection targets focusing on products with increased summer usage and items that have had recent quality issues.
Key inspection targets include a total of 34 product categories: daily-wear soft contact lenses, whose demand increases with outdoor activities and water recreation; wound dressings, which have had frequent quality non-compliance cases; and automated external defibrillators, which draw high interest in medical settings. The inspection also covers daily-use medical devices such as medical laser irradiators and personal heating devices.
MFDS plans to conduct comprehensive testing on collected products, including biological safety tests such as sterility testing, as well as electrical and mechanical safety and key performance criteria. The agency will particularly strengthen safety verification for devices that directly contact the human body or are directly linked to life.
Products found non-compliant with standards will immediately face sales suspension along with recall and disposal measures. Administrative penalties will also be imposed on related companies. Additionally, the results of these measures will be disclosed through the "Medical Device Safety Bookstore" platform so consumers can verify them directly.
"We will swiftly block quality non-compliant products through preemptive collection, inspection, and follow-up management of medical devices in distribution," an MFDS official said. "We will create a safe usage environment by thoroughly verifying everything from medical devices closely related to daily life to specialized medical equipment."
