Ministry of Food and Drug Safety begins Chuseok medical-device checks

The Ministry of Food and Drug Safety said on Aug. 4 it will inspect 173 medical-device products across 43 categories before the Chuseok holiday, focusing on safety and performance.

The third-quarter operation will be carried out jointly with six regional Food and Drug Safety administrations and will examine products circulating in the market, the ministry said. It is intended to assess devices likely to see increased use as gifts or for family health care, alongside frequently used products requiring ongoing quality control.

Products covered include low-level light therapy devices and limb compression circulation devices, expected to see stronger holiday demand, as well as electronic thermometers, automatic blood pressure monitors and powered medical suction devices. A second round of inspections will target adhesive transparent wound dressings and direct drug injection devices, product categories that failed to meet quality standards during last year's collection and inspections.

The ministry will conduct biological safety tests, including sterility tests, along with electrical, mechanical and key performance tests tailored to each device category. Products that fail to meet standards will be subject to immediate sales suspension, recall and disposal; the ministry will also pursue administrative action against relevant companies.

Results and follow-up measures will be published on the ministry's medical-device information website so consumers can check them directly, it said. The agency operates a system to collect, analyze and evaluate safety information identified during the handling and use of medical devices, then establish appropriate safety measures.