China radio frequency (RF) therapy devices classification has been clarified by the National Medical Products Administration (NMPA) following adjustments to certain sections of the Medical Device Classification Catalogue (Announcement No. 30 of 2022).
The implementation of Announcement No. 30 significantly impacted the classification and management attributes of RF devices used for cosmetic purposes. Therefore, in order to provide clarity and guidance on the classification of RF therapy devices, including RF treatment instruments and RF skin treatment devices, the Center for Medical Device Standardization Administration, under the guidance of the NMPA, has issued the following interpretations:
- Not all RF devices fall under medical device regulation. Determining whether a product falls under medical device management requires a comprehensive assessment based on the definition of medical devices as outlined in the Regulations on the Supervision and Administration of Medical Devices, along with classification rules and the Medical Device Classification Catalogue.
- In accordance with Announcement No. 30, RF therapy devices intended for medical use typically involve the application of RF energy to induce physiological changes in the skin and subcutaneous tissues. These devices are intended for various treatments such as skin tightening, wrinkle reduction, acne treatment, scar reduction, and fat reduction. As per the announcement, products meeting these criteria should be classified as Class III medical devices. For RF therapy devices falling under medical device regulation, if the product incorporates additional functionalities such as microcurrent stimulation, ultrasound therapy, intense pulsed light therapy, or cryotherapy, it should be classified based on the highest level of risk among its functionalities. For instance, a device offering both RF skin treatment and intense pulsed light hair removal functionalities would be classified as a Class III medical device.
- It’s essential to note that radiofrequency products not meeting the definition of medical devices, such as those intended solely for skincare, pore cleansing, or massage purposes, do not fall under medical device regulation.
Further information
Read the original NMPA interpretation on China RF Therapy Devices Classification Definition.
Read our previous blog post on Clinical evaluation of laser therapy devices – New guidelines issued.
Click here to know more about Medical Device Classification Catalogue Changes.
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