This resource is the “Guidelines for Registration Review of Radiofrequency Beauty Equipment” issued by the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA). It is an important technical basis for registering RF beauty products as Class III medical devices in China.
The guidelines are intended to guide registration applicants in preparing and writing registration documents for RF beauty equipment, and to provide a reference for technical reviewers when reviewing registration applications.
About this document
Under the relevant NMPA announcements, RF therapy devices and RF skin therapy devices are regulated as Class III medical devices. The guidelines set out the specific requirements for registration documents for these products, including product description, performance specifications, electrical safety and EMC, software, animal studies and clinical evaluation.
Applicable products and users
- RF beauty equipment such as RF therapy devices and RF skin therapy devices
- Manufacturers or import agents planning to apply for Class III medical device registration in China
Main contents
- Requirements for describing scope of application and structure and composition
- Key performance specifications (output power, temperature control, etc.)
- Non-clinical study and clinical evaluation requirements
- Special requirements for instructions for use and labelling
Obtaining the original text
The original text is available on the website of the NMPA Center for Medical Device Evaluation, or you can contact us for a copy.
Related articles
- A Complete Guide to Registering RF Beauty Equipment in China
- Functional Verification of Beauty Devices
- China Medical Device Registration (NMPA) Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.