UPDATE : Thursday, June 4, 2020
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YB Soft's wheelchair scores FDA's nod aided by state agency
  • By Shim Hyun-tai
  • Published 2020.05.08 18:17
  • Updated 2020.05.08 18:17
  • comments 0

YB Soft's anti-falling wheelchair, GL-010, won approval in the United States, becoming the first made-in-Korea wheelchair to gain a permit, according to the Korea Health Industry Development Institute (KHIDI) on Monday.

YB Soft's wheelchair is a product that has been certified as a new excellent technology in recognition of its brake solution that prevents from falling. After obtaining a certificate, the product was selected as a pilot purchase project for technology-based products, and the company could supply the chairs to government agencies.

The company received help from an “ambassador,” a U.S. Food and Drug Administration (FDA) expert who supports startups in the health industry in finding markets for their products. Thanks to the ambassador's support, the FDA's approval of the wheelchair has opened the way to enter the $1.5 billion U.S. market.

YB Soft said it would also proceed to win the Conformite Europeen (CE) mark to advance to the European market.

"We could not find an expert to help us gain approval for the wheelchair when the company first decided to advance to the U.S. market," YB Soft CEO Yoo Young-bae said. "There was a lot of difficulty due to insignificant time consumption, but the trouble was solved through the ambassador, through the efforts of the KHIDI.”

Ambassador Jeong In-sung at FDA Asia LLC, a regulatory consulting firm, stressed the importance of shortening the period through a professional agent, saying that domestic startups either have little understanding of the procedures of the FDA or have high financial burdens.

According to Eom Bo-young, a director of the KHIDI, there are many Korean startups armed with excellent technology in the health industry but suffer from lack of sales network and marketing experience.

The KHIDI will continue to support the ambassador's activities to help the products of startups can effectively enter overseas health markets, Eom added.

shim531@docdocdoc.co.kr

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