Starting from April 1st, there will be changes in the management of such medical device products!

Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices (No. 30 of 2022, hereinafter referred to as Announcement No. 30) clarifies that the subcategory 09 Physical Therapy Devices” and the Class I product category 07 High Frequency Treatment Equipment” in the Classification Catalogue of Medical Devices, as well as the Class II product category “02 Radio Frequency Treatment (Non ablation) Equipment”, are managed as the Class III  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.

 Recently, the Standard Management Center has made the following interpretation on the management attributes and category classification of this type of product:

1、 Not all RF products belong to medical devices. For whether a product is managed as a medical device, a comprehensive judgment should be made based on Article 103 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739) on the definition of medical devices, and the management category of the product should be determined based on the Classification Rules for Medical Devices, the Classification Catalogue of Medical Devices, and other criteria.

2、 According to Announcement No. 30, the working principle of radiofrequency therapy devices and radiofrequency skin therapy devices under medical device management is generally “to apply radiofrequency energy to human skin and subcutaneous tissue through treatment electrodes, causing pathological/physiological changes in human tissue and cells”; Expected to be used to treat skin laxity, reduce skin wrinkles, shrink pores, tighten and elevate skin tissue, or treat acne, scars, or reduce fat (softening or decomposition of fat). Products that comply with the provisions of Announcement No. 30 shall be managed as Class III medical devices.

For example, radiofrequency beauty products expected to be used to lighten wrinkles (such as lifting wrinkles, crow’s feet, etc.), reduce fine lines, remove wrinkles around the eyes, improve sagging and sagging, enhance apple skin, lift facial contours, tighten contours, tighten skin, lift and shape, and shrink pores should be managed as Class III medical devices.

For radiofrequency therapeutic devices and radiofrequency skin therapeutic devices that are managed as medical devices, if the product also has other functions (such as microcurrent stimulation, ultrasound therapy, strong pulse light therapy, cold compress, etc.), according to Article 6 (1) of the Medical Device Classification Rules,if the same medical device is applicable to two or more classifications, the classification with the highest risk level should be adopted”, and the product should be managed as a Class III medical device.

For example, if a product has two working mechanisms: radiofrequency skin treatment and strong pulse light hair removal, and the function of radiofrequency skin treatment is a Class III medical device, and the function of strong pulse light hair removal is a Class II medical device, then the product should be managed as a Class III medical device as a whole.

3、 RF products that do not meet the definition of medical devices are not managed as medical devices. For example, if the intended use does not involve the situation specified in Announcement 30, but is only used for “non-invasive skin penetration promotion of essence (not for drug and medical device penetration promotion), promoting essence absorption, skin surface cleaning, warm massage, physical massage, skin relaxation, exfoliation” or similar uses of RF products, then they do not meet the definition of medical devices and are not managed as medical devices.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com