[Edaily Reporter YU JIN-HEE ] HLB Life Science(067630)has obtained certification under the International Medical Device Single Audit Program (MDSAP), accelerating its entry into the global medical device market, including North America. HLB Life Science announced on the 25th that it has obtained MDSAP certification to expand its presence in the global medical device market.

MDSAP is a single quality management system (QMS) certification program jointly recognized by regulatory authorities in five countries: the United States, Canada, Australia, Japan, and Brazil. Since it rigorously verifies the quality management systems of manufacturing facilities in participating countries through a single audit, obtaining this certification alone demonstrates that the company possesses quality management capabilities and regulatory compliance systems that meet international standards.

This MDSAP certification covers HLB Life Science’s major syringe product lines, including disposable syringes, disposable needles, membrane filter syringes, and cleaning syringes. The entire process—from the design and development of these products through manufacturing and sales—is included in the scope of certification, thereby securing international recognition for the reliability of quality management across the entire product lifecycle.

The company anticipates that this certification will significantly reduce the burden of duplicate on-site inspections previously conducted separately by each country. Consequently, not only will this shorten overseas approval times and reduce costs, but it will also streamline quality verification procedures when entering into new contracts with global buyers and overseas partners, making future export negotiations and business development much smoother.

Following its entry into the U.S. medical device market, HLB Life Science plans to use this certification as a springboard to fully enter the Canadian market. Canada mandates MDSAP certification as a prerequisite for importing and selling medical devices. This achievement is seen as clearing the biggest hurdle to entering the local market. HLB Life Science is accelerating its ongoing export preparations while actively pursuing the expansion of local partnerships. Furthermore, the company plans to expand its reach into major developed markets, such as Australia, to solidify its position in the global medical device market.

Baek Yun-ki, CEO of HLB Life Science, emphasized, “This MDSAP certification is a significant achievement that officially recognizes our company’s quality management system for syringes as meeting the highest global standards.” He added, “Building on this, we will expand our presence in major overseas markets, including Canada, and continue to strengthen the competitiveness of our products in the global medical device market.”