GFC Life Science (GFC, Co-CEOs Kang Hee-cheol and Pyo Hyeong-bae), a company specializing in plant-based bio-raw materials, announced on the 13th that it had obtained a medical device manufacturing license from the Ministry of Food and Drug Safety (hereinafter referred to as the MFDS) .
GFC Life Science is entering the new medical device business based on the R&D capabilities it has accumulated through its plant-based bio-raw material business. It established a medical device manufacturing plant in its Dongtan headquarters in Hwaseong-si, Gyeonggi-do in May, and plans to launch its medical device business in earnest based on this manufacturing permit. The company is also preparing to obtain medical device manufacturing and quality management standards (KGMP) and ISO13485 (international quality management standard) certification.
GFC Life Sciences' strategy is to quickly enter the medical device market with non-sterile medical gel products and gradually introduce advanced products, such as commercializing topical hydrogel wound dressings within the year.
Non-sterile medical gel is a gel used in hospital ultrasound diagnosis to remove air between the human body and the medical probe and increase conductivity. As a class 1 medical device with almost no potential risk, it can be manufactured and sold after going through the reporting process, so sales are expected to occur within the first half of the year, the company explained.
Topical hydrogel wound dressing is a cream applied to areas with damaged skin barriers, such as minor first-degree burns or dry skin, for the purpose of protecting the skin. It is a class 2 medical device with low potential risk, and the goal is to receive approval from the Ministry of Food and Drug Safety and manufacture and sell it within the year.
Kang Hee-chul, CEO of GFC Life Science, said, “Based on our capabilities in developing cosmetics-specific biomaterials, we will showcase differentiated quality and technological prowess in the medical device market as well,” and added, “We plan to continuously expand our product lineup related to therapeutic medical devices, starting with non-sterile medical gels and topical hydrogel wound dressings.”
Founded in 2002, GFC Life Science is a bio-linked beauty tech company with differentiated competitiveness in ▲skin microbiome technology ▲skin flora change technology ▲exosome separation, retention, and mass production technology. Based on this, the company supplies approximately 1,000 types of plant-based bio-raw materials to famous domestic and foreign cosmetic brands, and is solidifying its position in the bio-beauty market.
Meanwhile, GFC Life Science is in the process of pursuing a KOSDAQ technology transfer listing. In August, it received an A grade from one of the specialized evaluation agencies designated by the Korea Exchange, passed the technology evaluation, and applied for a preliminary review for a KOSDAQ transfer listing to the Korea Exchange in December. As a profitable company, GFC Life Science will receive benefits such as a shortened review period and exemption from corporate continuity review through the fast-track listing system as it meets the sales and profit requirements. Daishin Securities was in charge of the listing.
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