Core Insights - The first domestic radiofrequency microneedle device, known as "Haidao Reverse Time," has received the Class III medical device registration certificate in China, marking a significant regulatory milestone for the company [1][2] - This device is the first in China to obtain both NMPA and FDA certifications, aligning with regulatory trends for radiofrequency products [2] - The approval of "Haidao Reverse Time" is expected to accelerate the expansion of domestic radiofrequency products, as companies aim to meet the upgraded regulatory standards [3] Regulatory Developments - The approval of the Class III medical device certificate aligns with the regulatory direction for radiofrequency products, as outlined in the announcement by the drug administration in July 2024 [2] - Starting from April 1, 2026, radiofrequency treatment devices will need to upgrade from Class II to Class III medical device registration, prompting companies to adapt quickly [2][3] Product Features and Market Impact - "Haidao Reverse Time" integrates monopolar, bipolar, and combined modes of radiofrequency microneedling, enhancing treatment efficiency and patient comfort [2] - The device is primarily used for treating acne and offers significant time savings and reduced discomfort compared to traditional methods [2] - The regulatory upgrade is expected to filter out less capable companies, fostering a shift from quantity expansion to quality competition in the domestic radiofrequency product market [3]

Core Insights - Viora Ltd., a wholly-owned subsidiary of Huadong Medicine, received acceptance for its V30 optical radiofrequency therapy device registration application from the National Medical Products Administration (NMPA) [1] - The V30 device integrates multiple energy sources including RF, IPL, and Nd:YAG laser, providing versatile treatment options for various skin issues [1] - The medical aesthetic energy device market is experiencing rapid growth, with significant consumer interest in energy-based treatments [4][3] Company Developments - Viora was acquired by Huadong Medicine's UK subsidiary Sinclair in February 2022, marking a strategic expansion into the medical aesthetics sector [1] - The V30 device has already received FDA and EU CE certifications, indicating its compliance with international standards [3] - The acceptance of the V30 registration application will enhance Huadong Medicine's product portfolio in the domestic medical aesthetics market [10] Market Overview - The Chinese medical aesthetics market for optical devices reached a scale of 35.674 billion yuan in 2022, with an estimated market size of 13.503 billion yuan in 2023 [5] - The market for medical aesthetic energy devices is projected to grow to 19.289 billion yuan by 2028 [6] - There is a notable increase in high-end consumer willingness to spend on medical aesthetics, with 26% of surveyed individuals indicating annual spending over 50,000 yuan in 2023 [7] Competitive Landscape - Despite the growth in the domestic market, high-end optical device manufacturers in China are still in the development phase, with foreign companies dominating the mid-to-high-end market [8] - There is a pressing need for more diverse and high-quality compliant medical aesthetic energy devices in the domestic market [9] - Huadong Medicine is actively working to introduce high-end energy source products to the domestic market, having already launched several products [9]