HLB Life Science Secures FDA 510K Approval for ‘Sofject’ Syringe

HLB Life Science’s “Sofject” disposable syringes (HLB Life Science)

HLB Life Science announced on Jan. 2 that its disposable syringe “Sofject” has received pre-market approval (510K) from the U.S. Food and Drug Administration (FDA). This approval marks a significant milestone for the company as it plans to export human-use syringes to the U.S. through Allison Medical starting this month.

The disposable syringe has been developed specifically for human use and has received the 510K pre-market approval from the FDA. This regulatory process allows for quicker market entry by comparing and evaluating the performance and equivalence of existing marketed medical devices. The approval includes both the syringe and the needle, ensuring that the product meets the stringent safety and efficacy standards set by the FDA.

To meet the anticipated demand, HLB Life Science is increasing the operational rates of its Cheonan and Anseong 2 factories to prepare for the shipment of export quantities to the U.S. The annual demand for disposable syringes in the U.S. market is expected to rise to approximately 240 million units, presenting a significant opportunity for HLB Life Science.

Lee Kwang-hee, vice president of HLB Life Science’s Medical Device Division, expressed optimism about the company’s future prospects. “With this product approval, we can fully enter the U.S. market,” he stated. “In the short term, we aim to turn a profit through exports, and in the mid to long term, we aim to become the number one company in the domestic syringe industry.”

In addition to the FDA approval, HLB Life Science plans to obtain certification for the Medical Device Single Audit Program (MDSAP) within this year. MDSAP is a single audit program for medical devices conducted by the U.S., Canada, Japan, Australia, and Brazil. Obtaining this certification will result in full or partial exemption from medical device audits in these five countries, further streamlining the regulatory process and facilitating market entry.

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