The Korean government has begun directly inspecting intravenous (IV) set production facilities as concerns grow over medical supply disruptions following the Middle East conflict. Industry players raised difficulties regarding raw material procurement, low reimbursement rates, and regulatory burdens.
The Ministry of Food and Drug Safety (MFDS) announced Wednesday that it visited IV set manufacturers jointly with the Ministry of Health and Welfare, Ministry of Trade, Industry and Energy, and Ministry of SMEs and Startups to review production and supply conditions and held an industry roundtable.
The measure comes amid concerns that geopolitical risks in the Middle East could disrupt petrochemical raw material supplies, potentially affecting overall medical product manufacturing. IV sets are among the most essential treatment materials used in hospitals, and any supply disruption could lead to significant chaos in medical settings.
Four IV set manufacturers with top market shares in Korea participated in the roundtable, sharing their production status and challenges. The industry presented key issues including stable raw material procurement, simplified approval procedures for component and material changes, and appropriate reimbursement rates reflecting cost increases.
IV sets are highly dependent on petrochemical-based raw materials such as naphtha, meaning supply instability directly translates into production disruptions. Additionally, as low-priced consumable medical devices, cost increases are difficult to reflect immediately in pricing, further contributing to supply concerns.
The government plans to respond by focusing on raw material supply and regulatory improvements. The MFDS will expedite medical device change approval procedures and work with the Ministry of Trade, Industry and Energy to pursue priority supply of naphtha, a key raw material.
This site inspection goes beyond simple supply verification, serving as a comprehensive review of the entire production-distribution-pricing structure. The move is interpreted as the government strengthening its cross-ministerial response system by viewing the medical product supply chain as essential infrastructure.
"IV sets are essential medical devices for patient treatment, and we will respond preemptively to prevent any supply instability," MFDS Commissioner Oh Yu-kyung said. "We will maintain a stable supply system through cooperation with relevant ministries."