WSI, EasyMedibot and Beijing HTKD Medical Secure Global Regulatory Approvals

WSI has begun efforts to obtain global regulatory approvals for its surgical robot ‘Ubots’ and to enter the Chinese market.

Jang Ling, CEO of HTKD Medical, and Yoon Seok Lee, CEO of WSI. WSI

On April 21, WSI announced that its subsidiary, EasyMedibot, has signed a strategic partnership agreement with Beijing HTKD Medical.

The two companies unveiled a collaboration plan that includes cooperation on supplying Ubots consumables, joint development of the second-generation uterine elevator, collaboration for Ubots registration and marketing in the Chinese market, and support for obtaining approvals from the U.S. Food and Drug Administration (FDA) and the European Medical Device Regulation (CE).

HTKD Medical is a Chinese government-certified high-tech company established in 1993. It is a specialized medical device manufacturer holding ISO 13485, CE, and U.S. FDA certifications, operating a production facility of approximately 4,000 square meters in Tongzhou District, Beijing. Of this, 625 square meters are designed as a clean room that meets Good Manufacturing Practice (GMP) standards, allowing for strict process control. With more than 20 proprietary patented products in fields such as general surgery, obstetrics and gynecology, cardiac surgery, and minimally invasive surgical devices, the company supplies products to global markets including the United States, Europe, and South America.

The core of this agreement is cooperation for Ubots’ entry into the Chinese market and the acquisition of global regulatory approvals. The two companies will utilize HTKD Medical’s obstetrics and gynecology distribution network in China to advance Ubots into the Chinese market. In addition, they have agreed to explore ways to collaborate in the approval process for the U.S. and European markets by leveraging HTKD Medical’s experience in obtaining FDA and CE certifications.

A WSI representative commented, “This partnership is a comprehensive collaboration that encompasses global regulatory strategies and local market entry,” adding, “HTKD Medical’s experience with FDA and CE certifications and its proven manufacturing capabilities will make a substantial contribution to enhancing Ubots’ quality stability and accelerating its overseas expansion.”

This content was produced with the assistance of AI translation services.