KTC-CAREGEN Signs Technical Service Contract to Expand into the European Medical Device Market
Korea Testing Certification institute (KTC) has announced its collaboration through a technical service contract with CAREGEN Co., Ltd. (hereinafter referred to as CAREGEN) to support the expansion of medical device exports to Europe.
Under this agreement, KTC will assess the biological safety of tissue restoration biomaterials required for CareGen's European MDR certification. Tissue restoration biomaterials are biologically derived materials used in tissue replacement, restoration, and reconstruction procedures. KTC will conduct a total of 7 GLP (Good Laboratory Practice) tests, including cytotoxicity, irritation, intracutaneous reactivity, genotoxicity, pyrogenicity, subchronic toxicity, and implantation tests, and prepare a comprehensive Biological Evaluation Report (BER).
MDR is a certification required for exporting medical devices to Europe and is scheduled for implementation in May 2024. As of 2021, the European medical device market is valued at €150 billion, making it the world's second largest after North America. Additionally, it boasts the highest per capita medical device market size at an average of $196.7, reflecting a substantial reliance on medical device imports.
In light of this, domestic companies are seeking to expand into Europe through MDR certification. However, the acquisition costs and time required for MDR are higher than those of the existing medical device management guidelines (MDD), presenting challenges for exports.
KTC plans to establish a cooperative relationship with European MDR certification authorities to assist domestic companies in obtaining European medical device certifications and achieving smooth entry into overseas markets.
Meanwhile, KTC is designated as the testing and inspection agency for the majority of product categories by the Ministry of Food and Drug Safety, as well as the inspection agency for medical device manufacturing and quality management standards (GMP). Additionally, KTC has established the country's first advanced, integrated medical device-specific GLP testing center to contribute to national safety.
President Sungil Ahn stated, "As the European medical device regulatory system strengthens, related companies need to be thoroughly prepared," and he added, "Based on KTC's testing and evaluation capabilities, we will redouble our efforts to expand our companies' presence in the European medical device market."
▲ KTC Bio-Health Center Exterior View
