HLB Life Science (067630.KQ) said Tuesday it has obtained certification under the Medical Device Single Audit Program (MDSAP) to expand its presence in the global medical device market. With the certification, the company now meets standards including quality management capabilities jointly recognized by regulatory authorities in five countries, including the United States and Canada.
The MDSAP certification covers major syringe product lines, including disposable syringes, disposable needles, membrane filter syringes, and irrigation syringes. The entire process of design and development, manufacturing, and sales of these products falls within the scope of the certification.
The certification is also expected to reduce the burden of duplicate inspections previously conducted on a country-by-country basis, enabling shorter overseas approval periods and cost savings. In addition, as quality verification procedures are simplified in the process of signing new contracts with global buyers and overseas partners, export negotiations and business operations are expected to proceed more smoothly.
HLB Life Science plans to begin its full-fledged entry into the Canadian market based on this MDSAP certification. Canada requires MDSAP certification as an essential condition for importing and selling medical devices, and the company has secured a key requirement for entering the local market through this certification.
"This MDSAP certification is a meaningful achievement that officially recognizes that the company's syringe quality management system meets global standards," said Baek Yoon-ki, CEO of HLB Life Science. "Based on this, we will expand our entry into major overseas markets, including Canada, and continue to strengthen our competitiveness in the global medical device market."
The MDSAP is a single quality management system (QMS) certification program jointly recognized by regulatory authorities in five countries, including the United States, Canada, Australia, Japan, and Brazil. It verifies the quality management system of manufacturing facilities through a single audit. Companies that obtain the certification are recognized as having quality management capabilities and regulatory compliance systems that meet international standards.
