The Food and Drug Administration is set to conduct a focused collection and inspection of home medical devices ahead of the Chuseok holiday. This initiative aims to proactively check the quality of medical devices that are expected to see increased use during the holiday period, thereby enhancing safety management.
On August 5, the agency announced that it will carry out the third quarter collection and inspection of medical devices in collaboration with six regional food and drug safety offices.
This collection and inspection are designed to preemptively assess medical devices that are likely to be used as gifts or for family health management during the holiday, reinforcing quality management for devices frequently used by the public.
The inspection will target 43 categories and 173 products, including low-level light therapy devices and limb compression circulation devices, which are expected to be in high demand during the holiday, as well as electronic thermometers, automatic electronic blood pressure monitors, and electric medical suction devices.
Additionally, the agency plans to re-inspect adhesive transparent wound dressings and direct drug injection devices, which had previously failed quality standards during last year's collection and inspection, to enhance the effectiveness of quality management for products in circulation.
Unapproved medical devices not only lack verified quality but also do not guarantee safety and efficacy, necessitating caution. The agency will conduct comprehensive checks on collected products, including biological safety tests such as sterility tests, as well as electrical and mechanical safety and major performance tests based on the characteristics of each item.
Products that do not meet inspection standards will be immediately removed from sale and recalled or disposed of, with administrative actions taken against the respective companies in accordance with relevant laws. The results of these actions will be made available to consumers through the Medical Device Safety Information Center.
The agency stated, "We will continue to manage the distribution of safe medical devices through proactive collection and inspections that consider seasonal and usage environments, and we will consistently verify the safety and performance of products, from everyday items to specialized medical devices in healthcare settings."
* This article has been translated by AI.
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