CGBio Medtech Obtains MDSAP Certification, Accelerating Global Expansion

Meets Quality Standards of Four Countries: United States, Japan, Australia, and Brazil

On March 13, CGBio Medtech, a company specializing in the research and manufacturing of internal implants, announced that it has obtained MDSAP (Medical Device Single Audit Program) certification, laying the groundwork for expanding its global reach.

MDSAP is an international medical device single audit program participated in by regulatory authorities from five countries: the United States, Canada, Japan, Australia, and Brazil. This program allows companies seeking to sell medical devices in multiple countries to have their compliance with each country’s quality management standards assessed through a single audit. It evaluates both common quality requirements and country-specific additional criteria. Through this certification, CGBio Medtech has been recognized for meeting the quality standards required by four of the five participating countries: the United States, Japan, Australia, and Brazil.

With this certification, CGBio Medtech’s quality management system throughout the entire production process—covering product groups such as orthopedic and spinal products, surgical catheters, and electrosurgical devices included within the certification scope—has been acknowledged as compliant with global regulatory standards. The company expects this will have a positive impact on addressing overseas regulatory approvals and expanding global partnerships going forward. In addition, it anticipates that this will serve as a solid foundation for the expansion of its Contract Development and Manufacturing Organization (CDMO) business.

Hyunseung Yoo, CEO of CGBio Medtech, stated, "Obtaining MDSAP certification is a significant achievement that officially recognizes CGBio Medtech’s quality management system as meeting the standards demanded by the global market. We will continue to enhance our quality competitiveness, strengthen the foundation for overseas regulatory approvals and export expansion, and grow as a trusted medical device company in the global market."

This content was produced with the assistance of AI translation services.