Chonnam National University Biomaterial R&BD Center Establishes a Bridgehead to Accelerate Global Market Entry for Korean Medical Devices
Global Certifications
7 cases — FDA 5, CE MDR 1, CE MDD 1
Expected Revenue
29 Billion KRW — Export 22B, Domestic 7B
The Chonnam National University Biomaterial R&BD Center (Director Kang Sung-soo) announced that it has established a foundation for overseas expansion by helping Korean medical device manufacturers obtain 7 global certifications—including the U.S. FDA and Europe's CE—through the "Medical Device Commercialization Promotion Project" (supported by the Ministry of Trade, Industry and Energy and the Korea Testing Laboratory, KTL).
The project involves various organizations including CNU BMC, Wonju Medical Device Techno Valley, Seoul National University R&DB Foundation, Korea Medical Device Industrial Cooperative Association, and Korea Smart Medical Device Industry Promotion Foundation. It aims to strengthen the export competitiveness of domestic medical devices and increase market share in the global high-value market.
Support Provided to TDM, BioOptics, DRGEM, and Noanix
- Technical document consulting & documentation
- Medical device testing, analysis, and evaluation
- Overseas licensing audit support (FDA, CE MDR/MDD)
"This achievement proves that the technological prowess of Korean medical devices is competitive in the global market. We will continue to actively support companies to ensure their sustainable growth internationally." — Director Kang Sung-soo