Leads the Taiwan Medical Device Industry as the First MDSAP Certified Company

Dr. Tim Hsu, G.M. of HMD BioMedical Inc. (left), is awarded by Mr. Bill Lin (right), G.M. of TÜV SÜD Taiwan.

HMD BioMedical Inc. has been developing medical device products, including blood glucose monitoring systems, since 2000. The company’s quality management system received rigorous review and approval from TÜV SÜD, resulting in Taiwan’s first MDSAP certificate. Leading the industry to meet the requirements of international quality management standards, HMD BioMedical enhances the competitiveness of Taiwan’s medical device industry in the international market.

By implementing MDSAP system management, the company ensures supply chain stability and strengthens risk assessment. MDSAP, proposed by the International Medical Device Regulators Forum (IMDRF), enables manufacturers to satisfy the regulatory requirements of multiple jurisdictions through a single audit process, reducing compliance timelines and costs.

Five regulatory authorities currently participate: the Australian TGA, Brazilian ANVISA, Health Canada, the U.S. FDA, and Japan’s MHLW/PMDA. TÜV SÜD provides comprehensive verification covering ISO 13485 standards and jurisdiction-specific requirements.