射频微针首张国产“械三证”花落半岛医疗

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]