Navigating the Classification of RF Therapy Devices: A Comprehensive Analysis
Published on March 27, 2024, the National Medical Products Administration (NMPA) has issued a critical clarification regarding the classification of Radiofrequency (RF) Therapy Devices and RF Skin Therapy Devices. This clarification comes as part of the adjustments made to the Medical Device Classification Catalogue, specifically under Announcement No. 30 (2022). The announcement places RF therapy devices, including those for skin treatment that do not involve ablation, under the management of Class III medical devices within the "09 Physical Therapy Equipment" subcategory, and "07 High-Frequency Therapy Equipment" primary category.
The implementation of Announcement No. 30 has significant implications for the management and classification of RF products used for cosmetic purposes. Under the guidance of the NMPA, the Device Standard Management Center has provided an interpretation to better guide and standardize the classification of RF therapy and skin therapy devices.
Firstly, it's critical to understand that not all RF products qualify as medical devices. The determination of whether a product is managed as a medical device is based on a comprehensive judgment according to the Medical Device Supervision and Management Regulations and the Medical Device Classification Catalogue.
According to Announcement No. 30, RF therapy devices managed as medical devices generally operate by applying RF energy to the skin and subcutaneous tissue through treatment electrodes, inducing pathological/physiological changes in tissue and cells. These devices are intended for treatments such as skin tightening, wrinkle reduction, pore shrinking, skin lifting, acne and scar treatment, or fat reduction (softening or dissolving), and thus, are classified as Class III medical devices.
For instance, RF beauty products designed for reducing wrinkles (e.g., forehead lines, crow's feet), fine lines, eye wrinkles, improving sagging skin, lifting facial contours, tightening skin, and shrinking pores are managed as Class III medical devices.
If an RF therapy device possesses additional functions (e.g., microcurrent stimulation, ultrasound therapy, intense pulsed light therapy, cryotherapy), it is classified according to the highest risk level involved, typically as a Class III device. For example, a product combining RF skin treatment and intense pulsed light hair removal functions would be managed as a Class III medical device, given that the RF skin treatment function falls under Class III, while the hair removal function is a Class II medical device.
Lastly, RF products that do not meet the definition of a medical device, such as those intended solely for non-invasive skin permeation enhancement, essence absorption, skin surface cleaning, or similar purposes, are not regulated as medical devices.
This announcement by the NMPA and its interpretation by the Device Standard Management Center marks a significant step in the regulation and classification of RF therapy devices, ensuring a clear and standardized approach to their management.
If you have any questions or need further clarification regarding the classification and regulation of RF therapy devices, or any other medical device-related inquiries, please do not hesitate to contact TX Medical at contact@txcro.com. TX Medical is committed to providing comprehensive support and guidance in navigating the complexities of medical device regulations and ensuring compliance with the latest standards and requirements.