HLB Life Science is accelerating its global market strategy after obtaining the Medical Device Single Audit Program (MDSAP) certification, an international quality standard for medical devices.
On June 25, HLB Life Science announced that it has received MDSAP certification, which is jointly recognized by regulatory authorities in the United States, Canada, Australia, Japan, and Brazil. MDSAP evaluates the quality management systems (QMS) of medical device manufacturers through a single audit process. Achieving this certification signifies compliance with international quality management and regulatory standards.
The certification covers HLB Life Science's key syringe products, including disposable syringes, disposable needles, membrane filter syringes, and cleaning syringes. The certification encompasses the entire process from product design and development to manufacturing and sales, ensuring the reliability of its comprehensive quality management system.
The company stated, "With MDSAP certification, we expect to reduce the burden of duplicate audits in different countries, shorten the time and costs associated with overseas approvals, and streamline quality verification processes in contracts with global buyers and overseas partners, facilitating smoother export negotiations."
This certification particularly opens doors for entry into the Canadian market, which mandates MDSAP certification for the import and sale of medical devices. HLB Life Science plans to accelerate its local market entry preparations and expand partnerships to intensify its efforts in the North American market.
Baek Yoon-ki, CEO of HLB Life Science, remarked, "This MDSAP certification is an official recognition that our syringe quality management system meets global standards. We will continue to expand our presence in key overseas markets, including Canada, and enhance our competitiveness in the global medical device market."
In addition, HLB Life Science's research and development (R&D) subsidiary has recently been selected as a joint research institution for the Ministry of Health and Welfare's project on 'Structure-Based AI Discovery of Low-Molecular-Weight Drug Candidates.'
Following its recent selection for a project by the Ministry of Agriculture, Food and Rural Affairs, the company has demonstrated its exceptional non-clinical validation capabilities and competitive edge in bio-research by securing this major R&D project focused on discovering anti-cancer drug candidates.