The NMPA released the draft version of “Registration Guideline for Radio Frequency Aesthetic Devices” on August 26. 2022 for feedback. Opinions need to be submitted by September 18, 2022.
The RF aesthetic devices described in this guideline refer to products utilizing radio frequency current (usually around 200k-5MHz) or electric field (usually 13.56 or 40.68MHz) and other electrical energy of a specific frequency to act on human tissue to generate thermal effects to achieve skin laxity, reduce skin wrinkles, shrink pores, firm/lift skin tissue, or treat acne, scars, or reduce fat.
The devices can be hospital based or home use with their specific requirements. NMPA reclassified 16 cosmetic products, including RF aesthetics, as medical devices with an announcement on March 30, 2022. Read more about Cosmetic Medical Device NMPA guidelines.
Key Elements of the Radio Frequency Aesthetic Devices Guideline
Registration unit division
It shall meet the requirements of the “Guidelines for the Division of Medical Device Registration Units”, and based on the technical principle, structural composition, performance indicators and scope of application of the product.
Vertical/desktop RF cosmetic devices and handheld RF cosmetic devices should be divided into separate registration units:
For vertical/desktop RF beauty equipment, the main unit and accessories are usually declared as the same registration unit. For single-use radio frequency accessories, it can also be declared separately, but the information of the host must be clearly used. The neutral electrode can be declared as a product component or used in conjunction with a general neutral electrode.
Conductive pastes, independent coolants, cooling tanks and other products used in conjunction with radio frequency beauty equipment are not the same registration unit as radio frequency beauty equipment. Non-medical functional accessories such as skin stickers and markers used in the treatment process are usually not regarded as product components.
Performance index requirements
The operating frequency, rated load, rated power of each mode, and the output energy and energy density with all available therapy electrodes should be clearly defined. Clear all the adjustable parameters, and the mode with pulse output mode should specify the pulse frequency and pulse interval.
The area and size requirements of the therapy electrodes should be specified. Dot matrix and microneedle electrodes should have clear electrode size and distribution spacing. The microneedle electrode should specify the length of the microneedle, and if it is adjustable, the adjustment range and adjustment method should also be specified.
If it contains a neutral electrode, it should meet the relevant microbial limit requirements.
If a foot switch is included, the foot switch shall meet the requirements of YY 1057.
If there is a temperature measurement function, the temperature measurement range and measurement accuracy should be specified. If it has a temperature control function, the temperature control range and control accuracy should be specified.
If it has a cooling function, the position of the cooling surface should be described in the product diagram, and the adjustment range and control accuracy of the cooling temperature should be specified.
If it has negative pressure function, the range and accuracy of negative pressure parameters should be clarified.
Electrical Safety Requirements
General safety should meet the requirements of GB 9706.1 standard. For equipment intended to be used in a home environment or other non-professional medical environment, it should meet the requirements of the YY 9706.111 standard.
For therapeutic products that use current effect to act on the human body, the special safety shall meet the requirements of the GB 9706.202 (GB 9706.4) standard. The treatment equipment that uses the electric field effect to act on the human body should consider the corresponding special safety requirements according to its design characteristics. For example, the frequency of 40.68MHz belongs to the ultra-short wave frequency range and should meet the requirements of the GB 9706.203 standard.
RF beauty equipment software is usually embodied as software components, and relevant software research reports should be provided in accordance with the relevant requirements for software components in the Guidelines for Registration and Review of Medical Device Software (Revised in 2022).
If the export of device data and treatment parameters is involved, cybersecurity-related research materials should be provided in accordance with the requirements of the Guidelines for the Review of Medical Device Cybersecurity Registration (Revised in 2022).
The biocompatibility of the parts in direct or indirect human contact with the finished product should be evaluated. The components expected to contact with the patient in the RF cosmetic device are mainly the therapy electrode and the neutral electrode.
The therapeutic electrode and neutral electrode used in non-invasive treatment are expected to be in short-term contact with the patient’s skin. According to the requirements of GB/T 16886.1, the biocompatibility evaluation should at least consider the following requirements: cytotoxicity, sensitization, and skin irritation.
Accessories for invasive treatments (including lattice and microneedle electrodes) are expected to contact with damaged skin or subcutaneous tissue, and biocompatibility evaluation should at least consider the following requirements: cytotoxicity, sensitization, and intradermal reactions. In addition, some microneedle electrodes need to be used with a specific protective casing.
The casing is expected to be in contact with the patient’s skin. However, because the microneedle electrode will pierce the skin during use, the casing may get contact with damaged skin or tissue. Therefore, the stimulation test Consider intradermal responses with reference to microneedle electrodes.
For hand-held devices, the device handle and treatment electrodes are expected to be in short-term contact with the patient’s skin, and biocompatibility evaluation should consider the cytotoxicity, sensitization, and skin irritation. When carrying out biocompatibility evaluation, the device can be considered as a whole, or it can be considered separately according to the handles and treatment electrodes that contact different parts of the human body.
Outline of the Guideline for Radio Frequency Aesthetic Devices
The guideline contains the following seven parts:
1. Regulatory information
a) Product name
b) Management categories
c) Registration unit division
d) Overseas listing certificate (imported products)
2. Summary information
b) Product Description
c) Scope of application and contraindications
3. Risk management information
4. Product technical requirements
a) Basic information
b) Performance index requirements
c) Functional Requirements
d) Electrical Safety Requirements
e) Electromagnetic Compatibility Requirements
5. Testing report
6. Research materials
a) Performance studies
b) Study on the mechanism of action
c) Dose-response relationship and energy safety studies
d) Software Research
e) Biology research
f) Cleaning, Disinfection, Sterilization Research
g) Stability studies
h) Animal testing
i) Use Environmental Research
j) Clinical Evaluation Requirements
7. Product specification and label sample
Along with the guideline are three indexes:
- The main risk points of RF Aesthetic Devices
- Electromagnetic compatibility emission performance requirements for RF Aesthetic Devices
- Applicable standards for RF Aesthetic Devices
For an English copy of the draft guideline with indexes, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.