The US Food and Drug Administration (FDA) has granted pre-market approval (510K) to HLB Life Science’s Sofject disposable syringe, reported BusinessKorea.
This clearance is pivotal for the company’s strategy to ‘export’ human-use syringes to the country via Allison Medical, beginning this month.
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The FDA’s pre-market approval process allows for quicker entry into the market through the comparison of new devices to those already on the market.
This approval covers the syringe and the needle, guaranteeing that the product adheres to the US regulator’s stringent efficacy and safety requirements.
To address the expected increase in demand, the company is also ramping up production at its Cheonan and Anseong 2 plants.
The US market’s annual demand for disposable syringes is projected to reach around 240 million units, signifying a considerable market opportunity for the company.
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By GlobalDataAdditionally, the company is aiming to secure the Medical Device Single Audit Program (MDSAP) certification by this year.
The MDSAP allows for a unified audit process across the US, Japan, Canada, Australia, and Brazil, potentially exempting the company from multiple medical device audits in these countries, thus expediting market access.
HLB Life Science medical device division vice-president Lee Kwang-hee said: “With this product approval, we can fully enter the US market. 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.”
Specialising in pharmaceuticals and biotechnology, South Korea-based HLB Life Science is at the forefront of new drug development through its research and development capabilities and collaborations with international partners.
