According to an announcement issued by the National Medical Products Administration in March 2022, the product management class of radiofrequency therapy devices and radiofrequency skin treatment devices in radiofrequency treatment (non-ablation) device have been adjusted from Class II to Class III. Starting from April 1, 2024, radiofrequency therapy devices and radiofrequency skin therapy products may not be produced, imported, or sold without obtaining a medical device registration certificate in accordance with the law.
Regarding the registration application for radiofrequency beauty equipment, the Center for Medical Device Evaluation of NMPA issued the “Guiding Principles for Registration and Review of Radiofrequency Beauty Equipment” in April 2023. These include its application scope, regulatory information, product description, risk management information, product technical requirements, inspection reports, research information and clinical evaluation requirements, etc. Common radiofrequency beauty device and treatment accessories are shown in Figure 1-4. (Pictures all come from: “Guiding Principles for Registration and Review of Radiofrequency Beauty Devices”)
