National Medical Products Administration: Radiofrequency therapy equipment and radiofrequency skin therapy equipment are not allowed to be produced, imported, or sold without obtaining a medical device registration certificate in accordance with the law

On March 30th, 2022, the National Medical Products Administration issued a notice on adjusting some of the contents of the Classification Catalogue of Medical Devices, which clarified that radiofrequency therapy devices and radiofrequency skin therapy devices are managed according to the third category of medical devices. Starting from April 1, 2024, products such as radiofrequency therapy devices and radiofrequency skin therapy devices shall not be produced, imported, or sold without obtaining a medical device registration certificate in accordance with the law; Starting from April 1, 2024, enterprises that have not obtained a medical device production and operation license (filing) are not allowed to engage in the production and sales of related products. At the same time, Announcement No. 30 requires registrants and manufacturing enterprises related to radiofrequency therapy devices and radiofrequency skin therapy devices to effectively fulfill their main responsibility for product quality and safety, comprehensively strengthen product quality management throughout the entire lifecycle, ensure the safety and effectiveness of marketed products, and proactively report relevant situations to the provincial drug regulatory department in the location (where imported products are agents).