The Ministery of Food and Drug Safety said on Feb. 6 that, under this year's basic plan for manufacturing and distribution management of medical devices, it will conduct first-quarter collection and testing jointly with six regional Ministery of Food and Drug Safety offices to check the quality and safety of medical devices currently distributed on the market.
The Ministery of Food and Drug Safety conducts collection and testing each quarter every year on manufactured or imported medical devices that have received approval or certification. In the first quarter of this year, by analyzing products widely sold in free trial rooms, online shopping mall purchase reviews, and complaint cases, 52 items, including personal heating devices, personal low-frequency stimulators, and electric breast pumps, were included as targets.
Products subject to collection will be secured by purchasing them directly at distribution sites and online stores. For the secured products, testing and inspection will focus on electrical and mechanical safety, electromagnetic safety, and key performance items by product.
Products that do not meet the testing standards will immediately face sales suspension and recall and disposal measures, and related companies will be subject to administrative action under the law. The results of the measures will be disclosed on the Medical Device Safety Store website.
The Ministery of Food and Drug Safety noted that quality control needs to be carried out throughout the entire process from manufacturing to distribution and post-management. It said it will continue inspections to reduce consumer harm caused by underperforming or poor-quality products.