Overview
This report summarises the 2025 October MFDS medical device clinical trial approvals. The Ministry of Food and Drug Safety (MFDS) is a government agency responsible for public health in South Korea, ensuring the safety and effectiveness of foods, pharmaceuticals, medical devices and cosmetics. The agency was upgraded from an administration to a ministry in 2013 and established a dedicated Medical Device Management Division in 2004. In 2022 the MFDS approved 711 Investigational New Drug (IND) applications, of which 49 percent were global, 35.3 percent domestic and 16 percent investigator‑initiated. The IND system simplifies dossiers and follows a five‑step process—submission, consultation, review, result notification and supplementation or final decision—with a target review time of 30 working days.
In this environment, three clinical‑trial medical devices received MFDS approval in October 2025. They are outlined below along with translations of the original Korean data. The full data are provided in an attached Excel file on our website.
Optical dental caries diagnostic device
Qraycam Pro study
The first device approved is an optical dental caries diagnostic system. The investigator‑initiated exploratory trial, titled “Observation of fluorescence expression characteristics using Qraycam Pro on lesions and normal mucosa of patients with oral potentially malignant disorders (OPMDs)”, will monitor fluorescence patterns in patients’ lesions and normal mucosa. Qraycam Pro uses quantitative light‑induced fluorescence (QLF) technology to detect red fluorescence from porphyrin metabolites secreted by oral bacteria. The intensity of red fluorescence increases as halitosis‑inducing Gram‑negative bacteria increase, enabling visual assessment of bacterial activity and dental plaque. This non‑invasive, radiation‑free approach may help detect early caries and oral precancerous lesions.
Biomaterial for tissue repair
Hyaluronic acid filler comparison trial
The second approval concerns a biomaterial for tissue repair (hyaluronic acid filler). The trial, titled “Single‑center, randomized, independent evaluator/subject‑blinded, active‑controlled, paired, non‑inferiority confirmatory clinical trial comparing the efficacy and safety of DHP5243 and DHP5243R in adults requiring temporary improvement of moderate to deep nasolabial folds”, aims to determine whether the new filler is non‑inferior to the control. Hyaluronic acid‑based fillers are increasingly popular for minimally invasive wrinkle correction; a prospective randomized study found that a new monophasic HA filler significantly improved nasolabial folds and showed a safety profile comparable to Juvederm®, with only mild, transient local reactions. Participants were satisfied with the cosmetic improvement. The upcoming trial will assess wrinkle reduction, skin elasticity and safety, potentially enhancing the competitiveness of domestic fillers in the aesthetic market.
General electrosurgical device
Skin elasticity improvement trial
The third approval is a general electrosurgical device for temporary improvement of facial skin elasticity. Electrosurgical units typically use high‑frequency current for cutting and coagulation, but they can also deliver radiofrequency or neuromuscular electrical stimulation to stimulate dermal collagen and improve skin firmness. Home beauty devices using radiofrequency, LED and microcurrent have gained popularity for skin tightening, although research is limited and reported adverse effects are usually transient redness and swelling. An eight‑week prospective split‑face study using high‑frequency neuromuscular electrical stimulation (fNMES) reported significant improvements in skin elasticity, wrinkle depth, jawline and cheek volume, along with increased blood flow, demonstrating the promise of non‑invasive electrical stimulation for facial rejuvenation.
The approved trial is prospective, single‑center, randomized, evaluator‑blinded and superiority‑designed. Researchers will compare outcomes between treated and control areas to assess improvements in skin elasticity and monitor adverse events. By exploiting the adjustable energy delivery of electrosurgical units, the study aims to induce dermal collagen remodeling without significant downtime. The results could broaden the aesthetic applications of electrosurgical technology and stimulate innovation in the medical‑device industry.
Conclusion
In October 2025 the MFDS approved only three clinical‑trial medical devices—an optical caries diagnostic device, a hyaluronic acid filler and a general electrosurgical unit. Each represents a distinct area of innovation: non‑invasive fluorescence‑based diagnostics, next‑generation dermal fillers and electrical stimulation for skin rejuvenation. South Korea’s transparent and efficient regulatory system continues to attract global and domestic developers, positioning the country as a hub for advanced medical‑device research.
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