The Guidelines for Registration Review of Radio Frequency (RF) beauty devices in China is a consolidated document that guides registration applicants and technical review departments on how to prepare registration application materials for RF beauty devices.
These guidelines are meant specifically for RF beauty devices, which include devices used for skin treatment, fat reduction, and other cosmetic purposes; such devices use high-frequency current to act on the human body.
However, the guidelines are not applicable to high-frequency surgical equipment used in plastic surgery, as their effect on these devices is different from that on RF beauty devices.
This blog provides an overview of all the Regulatory information manufacturers intending to register and sell RF cosmetic devices in China require.
The “Regulatory information” section of the guidelines covers the following topics:
- Regulatory Basis
- Registration Requirements
- Summary Data
- Product Labeling
- Product Instructions
- Product Advertising
- Product Quality Management
- Product Recall Management
- Product Technical Documentation
- Product Registration Certificate
- Product Changes and Updates
- Product Transfer and Termination
- Product Supervision and Inspection
- Legal Liability and Dispute Resolution
Let us now look at each of the above topics in further detail:
- Scope: This set of guidelines is a general requirement for RF beauty devices, and the applicant should determine whether the content is applicable, based on the specific characteristics of the product. If it is not applicable, the applicant must explain in detail the reasons and the corresponding scientific basis, following which the content of the registration application materials shall be enriched and refined according to the specific characteristics of the product.
- Regulatory Basis: The product must have a corresponding Regulatory basis and the necessary certification documents that will allow the product to be marketed in the country of origin.
- Registration Requirements: The applicant must submit a complete registration application, as per the National Medicinal Products Administration (NMPA) medical device registration, including summary data, product labeling, product instructions, and product technical documentation. The technical review department will then evaluate the application, and if necessary, they may request for additional information or testing.
- Summary Data: The “summary data” section should include an overview of the product, along with its management category and classification code. The applicant should provide an outline of the declared product, including the general name of the product and the basis for its determination.
- Product Labeling: The label should include the product name, the manufacturer’s name and address, product model, and any other required information, as per NMPA China’s medical device regulations.
- Product Instructions: This section describes the requirements for product instructions, including the information that the applicant should include and the format and language in which they need to provide the instructions. It should include information on the product’s intended use, operating instructions, and safety precautions, as per NMPA’s medical device classification.
- Product Advertising: The advertising should be truthful and not misleading in any way; it should include information on the product’s intended use, limitations, and potential risks. The advertising should not make claims that are not supported by scientific evidence. Moreover, it should not imply that the product is approved or endorsed by the Regulatory authority. The manufacturer should maintain records of all advertising materials and must be prepared to provide them to the Regulatory authority upon the latter’s request.
- Product Quality Management: The manufacturer should establish a Quality Management System (QMS) that includes procedures for product design, production, testing, and inspection, as per China’s medical device regulations and the Centre for Medical Device Evaluation (CMDE). The manufacturer should also maintain records of all quality-related activities.
- Product Recall Management: The manufacturer should have a recall plan in place, which includes procedures for identifying and notifying affected customers, retrieving affected products, and reporting the recall to the Regulatory authority.
- Product Technical Documentation: The technical documentation should include information on the product’s design, manufacturing, testing, and performance; and the documentation should be organized in a clear, concise, and logical manner.
- Product Registration Certificate: The product registration certificate should be in accordance with China’s medical device registration process. The certificate must include information on the product’s name, model, and manufacturer, as well as its date of issuance and validity period.
- Product Changes and Updates: The manufacturer should notify the Regulatory authority of any changes or updates to the product that may affect its safety or efficacy. In addition, they need to maintain records of all such changes and updates.
- Product Transfer and Termination: The manufacturer should notify the Regulatory authority of any transfer or termination of the product registration; and they must maintain records of all such transfers and terminations.
- Product Supervision and Inspection: The Regulatory authority may conduct product inspections to ensure compliance with the Regulatory requirements, and the manufacturer should cooperate with the Regulatory authority during the inspection process. Moreover, the manufacturer must maintain records of all inspections and should be prepared to provide them to the Regulatory authority upon the latter’s request.
- Legal Liability and Dispute Resolution: The Regulatory authority may take enforcement action if they find the product to be non-compliant. Thus, the manufacturer should have procedures in place for handling complaints and disputes, and they should be prepared to cooperate with the Regulatory authority for resolving any issues that may arise. In the event of a dispute, the manufacturer may be required to provide evidence to support their position, and they could be subject to legal liability if the Regulatory authority finds the product to be defective or non-compliant. In such cases, the manufacturer should maintain records of all transfers and terminations.
In conclusion, the Guidelines for Registration Review of RF beauty devices in China encompasses a comprehensive set of Regulatory requirements for manufacturers intending to register and sell RF beauty devices in the country. The document covers various aspects of the registration process, including product naming, management categories, and classification codes. It also emphasizes the need for detailed research materials and verification to support the registration application. While the document is not enforced as a regulation, it does serve as a useful reference for registration applicants and technical review departments.
If you are looking to register your RF beauty devices in accordance with China’s medical device regulations, contact Freyr for expert Regulatory guidance and support. Stay informed! Stay compliant!