GeneJet Biotech Co., Ltd. is dedicated to research and development, manufacturing and sales of cyanoacrylate polymer bio-adhesive medical equipment. In 2014, it has successfully developed the first medical device in Taiwan that can replace skin sutures. And it has continuously obtained the product certification of EU CE and Taiwan TFDA. The product quality is comparable to the well-known European and American manufacturer and has been adopted by many medical centers in Taiwan. TissueAid Tissue Adhesive has currently been marketed to South Korea, Singapore, Saudi Arabia, Turkey, Brazil, UK, Greece, the Philippines, Italy and Southeast Asia, just to name a few.
Thanks to the successful experience of “TissueAid Tissue Adhesive”, GeneJet Biotech is preparing to invest in the development of the Class III of medical devices. Charles Chu, the chairman of GeneJet Biotech, said that the company had spent considerable efforts to build a manufacturing plant that complies with international certifications ISO 13485 and GMP in the early days of its establishment; and under the guidance of the Ministry of Health and Welfare, it successfully obtained Taiwan and international certifications
Although developing Class III medical devices requires more stringent certification requirements, with the successful experience of “TissueAid Tissue Adhesive”, GeneJet Biotech can save a lot of unnecessary exploration and cost. In addition, its established international sales networks significantly shorten the time to market.
Charles Chu further said that because Class III medical devices have a very high entry barrier, they can also bring higher profits to the company. At present, the company's R&D team for the Class III medical devices has entered the final evaluation and preparation stage. Charles Chu planned to invest in R&D force in the fourth quarter of 2017. GeneJet Biotech is expected to take 2 years to obtain CE certification and Taiwan FDA and use the existing international sales channels to market the world with its own brand.