HTDK and Sofwave Advance into Commercialization Following NMPA Class III Approval in China

The approval represents an important milestone for Sofwave Medical in mainland China and marks the transition of the HTDK–Sofwave partnership from regulatory market entry to commercial execution. With the registration process completed, the two companies will now move forward with product launch preparation and broader market development in China.

“We are very pleased to reach this important milestone with Sofwave and congratulate both teams on the sustained effort behind this achievement. For global innovative medical technology companies, securing regulatory approval is a critical step. The next priority is to connect global innovation with strong local market capabilities. In the next phase, we will focus on commercial execution, leveraging HTDK’s capabilities across channels, supply chain and market operations to accelerate Sofwave’s development in China.”

— Teresa Chen, Chief Executive Officer, HTDK

“China is an important market for non-invasive aesthetic treatments, and this approval enables Sofwave’s clinically proven technology to further enter the Chinese market. HTDK has been an important partner throughout the regulatory approval process. We are now focused on steadily advancing the commercial launch and expanding our presence in China.”

— Louis Scafuri, Chief Executive Officer, Sofwave Medical

As China’s medical aesthetics sector continues to evolve, the market is placing increasing emphasis on regulatory compliance, clinical evidence, technology quality and long-term value.
For innovative medical aesthetics technologies, clear clinical value and a compliant pathway to market are becoming increasingly important to building long-term trust and sustainable market development.