From April 1, 2024, some cosmetic devices shall not be produced, imported, or sold without obtaining a medical device registration certificate, which include radiofrequency (RF) equipment. For the list of devices, please click HERE
NMPA released the final version of “Registration Guideline for Radiofrequency Aesthetic Devices” on April 12, 2023.
The radiofrequency (RF) aesthetic equipment, a Class III device, refers to products that use electrical energy such as radio frequency current (usually 200kHz or more) or electric field (usually 13.56 or 40.68MHz) to act on human tissues to produce thermal effects to treat skin sagging, reduce skin wrinkles, shrink pores, firm/lift skin tissue, or treat acne, scarring, or reduce fat (fat softening or breakdown). They include standing, desktop, and handheld devices.
Big players in the RF aesthetic market include Alma Lasers, Cymedics Cynosure, Beco Medical, EndyMed, Inmode, Lumenis, Lutronic, Ibramed INDIBA, SharpLight Technologies, Venus Concept, Candela, and Solta Medical, some of which already entered China.
Review Focus Areas
The 29-page RF equipment guideline elaborates the review focus areas. The key elements are described as following:
- 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 aesthetic 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 aesthetic equipment are not the same registration unit as radio frequency aesthetic 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.
- Functional Requirements
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.
- Software Research
RF aesthetic 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).
- Biological research
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.
To get the three vital parts of biocompatibility evaluation that NMPA mentioned in the guideline, please email us at info@ChinaMedDevice.com
Outline of the Guideline
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
a) Overview
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 r RF Aesthetic Devices
- Electromagnetic compatibility emission performance requirements for RF Aesthetic Devices
- Applicable standards for RF Aesthetic Devices
For an English copy of the guideline with indexes, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.
Manufacturers face much stricter requirements in their product life cycle management. Please click HERE to read more.
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- Source: https://chinameddevice.com/rf-equipment-nmpa/
