On March 30, 2022, China National Medical Products Administration (NMPA) issued an announcement on adjusting Medical Device Classification Catalog. 1 According to the announcement, radio frequency (RF) beauty devices will be managed as Class III medical devices and subject to registration with NMPA. Starting from April 1, 2024, RF beauty devices without medical device registration certificate shall not be produced, imported or sold in China.
On April 12, 2023, NMPA's Center for Medical Device Evaluation issued Guidelines for Review of Registration of Radio Frequency Beauty Devices (Guidelines) to assist enterprises in preparing registration application documents and technical review department under the supervision authority in reviewing documents. 2 Key points are summarized as follows.
Application Scope
According to the Guidelines, radio frequency beauty devices refer to "products that use RF electric currents at specific frequencies (usually above 200kHz) or electric fields (usually 13.56 or 40.68MHz) or other electrical energy to produce thermal effects on human tissue, in order to achieve the treatment of skin laxity, the reduction of wrinkles, pore shrinkage, skin tissue tightening/lifting, the treatment of acne or scars, or the reduction of fat (softening or breakdown of fat).”
The RF beauty devices applicable to this Guidelines include vertical/desktop (large) devices and also handheld (small) devices.
Noteworthy Points
According to the Guidelines, documents that companies need to provide when applying for the registration of RF beauty devices include:
1) Overview information2) Risk management information
3) Technical requirements for the product
4) Testing reports
5) Research information
6) Clinical evaluation requirements
7) Product instruction and label sample
When preparing the above documents, noteworthy points mentioned in the Guidelines include:
In the application scope information, the expected usage environment, operators of the product, application site and use purpose should be clearly stated. Depending on the intended use, enterprises are recommended to use the following standard expressions: "for the reduction of (body, facial) skin wrinkles", "for the treatment of acne", "for the treatment of (body, facial) atrophic scars", "for the reduction of subcutaneous fat (abdomen, flank)", etc. For special areas such as the eyes, cheeks, and neck, the available and prohibited areas should be indicated through image;
For imported products, if they are not managed as medical devices in the country of origin, corresponding regulatory basis and supporting documents that prove those products’ market entry in the country of origin should be provided;
RF beauty devices are not exempted from clinical evaluation and should follow the recommended clinical evaluation path for "Physical Therapy Devices" under subcategory 09 of the Medical Device Classification Catalog. This means that RF beauty devices must undergo clinical evaluation before entering the market;
According to Qingyan, leading beauty device brands like Flossom, YA-MAN, and OGP have already applied for the filing of clinical evaluation projects for their RF devices, ushering in a new era in the industry. 3
Seven common standards applicable to RF beauty devices are clarified.
Standard No. | Standard Name |
GB 9706.1 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance |
YY 9706.102 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility - Requirements and Tests |
YY 9706.111 | Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment |
GB 9706.202 | Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories |
GB 9706.203 | Medical Electrical Equipment - Part 2-3: Particular Requirements for the Basic Safety and Essential Performance of Short-wave Therapy Equipment |
YY/T 1057 | General Specifications for Medical Foot Switch |
GB/T 16886.1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process |
Industry Comments
In the future, RF beauty devices will be classified as Class III medical devices, requiring companies to increase investment in R&D, experiments, clinical evaluations, and production processes. This will lead to the elimination of low-end brands without core technology and R&D capabilities from the market. During the grace period, brands that do not intend or lack the necessary conditions to apply for registration certificates may clear their inventory.
The beauty device industry is set to experience a major reshuffle as brands compete fiercely on core technology, R&D capabilities, medical qualifications, product quality, and sales channels. This will lead market share further concentrates among leading companies that are compliant with regulations.
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