SugenTech Obtains MFDS Export Approval for COVID-19 Rapid Diagnostic Kit

[Asia Economy Reporter Eunmo Koo] SuzenTech has received export approval from the Ministry of Food and Drug Safety (MFDS) for its rapid diagnostic kit for COVID-19, and is set to begin full-scale supply to the global market.

On the 25th, SuzenTech announced that its COVID-19 antibody rapid diagnostic kit, ‘SGTi-flex COVID-19 IgG/IgM,’ has obtained export approval from the Korean MFDS, completing all necessary authorization procedures for export.

Currently, SuzenTech’s COVID-19 rapid diagnostic kits have confirmed export contracts with six countries across Europe and Asia, including Italy, Germany, Austria, the Philippines, and Thailand, and the first batch of mass production is underway. With this export approval, all mass-produced units will be exported without any issues.

To export diagnostic kits produced in Korea, export approval from the Korean MFDS and authorization from the importing countries are required. SuzenTech has already completed the European CE certification, which is recognized by most countries in Europe, Asia, the Middle East, South America, and Africa. According to the company, this MFDS export approval effectively enables SuzenTech to export to most countries worldwide.

A SuzenTech official stated, “The ‘SGTi-flex COVID-19 IgG/IgM’ kit simultaneously diagnoses IgG and IgM antibodies. By simply dropping one drop of fingertip blood or whole blood onto the kit without a ‘plasma separation’ process, it can rapidly determine COVID-19 infection status within 10 minutes. This feature has drawn significant attention, causing our website to crash due to high demand, and overseas supply requests have surged.” The official added, “Although we are focusing all efforts on increasing mass production, we are currently unable to meet the rapidly growing demand.”

Son Mijin, CEO of SuzenTech, said, “We are pleased that the performance of our COVID-19 antibody rapid diagnostic kit has been recognized, having received both the European CE certification and MFDS export approval. Thanks to the proactive support of MFDS officials, we were able to obtain export approval quickly, allowing us to proceed with the export of the first production batch to six countries, including Italy, as planned by the end of March.” She added, “There is also high demand from the United States, and we plan to apply for the U.S. FDA’s Emergency Use Authorization (EUA) in the future.”