Guidelines For The Classification And Definition Of RF Products In Cosmetic Dermatology
2021-08-12
The development of “beauty economy” has brought unprecedented benefits to the boom of cosmetic medicine industry. Cosmetic instrument, in particular radio frequency (RF) products in cosmetic dermatology like thermage, is becoming popular among young consumers with an expanding market.
For the better development and supervision of RF products in cosmetic dermatology, NMPA issued a notice to collect comments on the Guidelines for the Classification and Definition of RF Products in Cosmetic Dermatology. Based on the draft Guidelines, the following three kinds of RF products will be regulated as medical devices.
RF products in cosmetic dermatology are expected to use RF energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue), achieve local superficial mild heating and improve blood circulation;
RF products in cosmetic dermatology are expected to use RF energy to act on human body (including but not limited to skin tissue and deep subcutaneous soft tissue), cause pathological / physiological changes in human tissues and cells, and may cause potential impact or damage to human body (such as edema, erythema, scald, micro scar, subcutaneous fat necrosis and collapse and other clinical diseases);
RF products in cosmetic dermatology are directly used (including but not limited to) to dissolve fat, shape, scar treatment, significantly change skin texture and other clear medical treatment behaviors, and may cause potential impact or damage to human body (such as immediate tissue contraction reaction, tissue degeneration, cell apoptosis, etc.).
According to the risk degree of RF products in cosmetic dermatology, their management category in China shall not be lower than Class II.
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