recently，The Medical Device Standards Management Center of the State Food and Drug Administration issued a notice on its official website on soliciting opinions on the "Guiding Principles for the Classification and Definition of Radio Frequency Beauty Products" (Draft for Solicitation of Comments)，In the relevant draft，Clarify that RF beauty products should be managed as medical devices。
Southern Metropolis reporter noticed，The draft for comments also stipulates，According to the risk level of RF beauty products，Its management category should not be lower than Class Ⅱ。There are also products that need to be managed in accordance with Class III medical devices，The highest category for the relevant departments to manage medical devices according to the degree of risk from low to high。
An insider said in an interview with a reporter from Nandu，At present, a major trend in the country is that the control of medical devices is becoming more and more stringent.，Including hospital radio frequency equipment，Household RF beauty products, etc.。In addition，Some medical and aesthetic institutions do not have a qualification certificate，Not rigorous operation，Irregularities cause all kinds of problems。Regularization of supervision is also a protection for patients。
Release of relevant drafts for comments
Nandu Big Data Research Institute、At a beauty salon think tank held by the Southern Metropolis Appraisal and Evaluation Laboratory，Su Liang, attending physician at Guangzhou Huamei Medical Beauty Hospital, said，Before，The State Food and Drug Administration puts home beauty instruments under the management of non-medical devices，This is what we usually call "life beauty" products，Skin care appliances under the category of small appliances under supervision。
"Because home beauty equipment is a part between medical beauty equipment and ordinary small appliances，So roughly with medical beauty equipment，That is to ask for medical equipment or for ordinary electrical appliances，May not be so suitable。"This also means，Home beauty products were once in a "grey area" between non-medical devices and medical device supervision。
at the same time，Beauty instrument products are getting more and more attention and acceptance by the public，A poll recently released by the Southern Metropolis Appraisal and Evaluation Laboratory shows，Only 18.8% of the respondents said that they have never used or planned to buy a beauty instrument。And when choosing the type of beauty instrument to buy or plan to buy，8.91% of the respondents chose "RF Beauty Apparatus"。
The Medical Device Standards Management Center of the State Food and Drug Administration pointed out on its official website，In addition to the current applications of radio frequency technology in the medical field，Also widely used in other fields such as daily life，Simultaneously，Wide variety of RF beauty products，Different structures and uses，A clear basis is needed for the determination and classification of its management attributes。
Currently，This situation is expected to improve。According to the "Guiding Principles for the Classification and Definition of Radio Frequency Beauty Products (Draft for Soliciting Comments)" (hereinafter referred to as "Draft for Soliciting Comments")，Radio frequency beauty products that comply with the meaning of medical devices in the Regulations on the Supervision and Administration of Medical Devices,Should be in accordance with medical device management。
This principle can be used to regulate the classification and definition of radio frequency beauty products in the field of medical devices，And provide technical guidance on registration and approval for industry and regulatory authorities。
RF beauty products to achieve local superficial and gentle heating purposes
Should be in accordance with the medical device management
The physical therapy device professional group of the Medical Device Classification Technical Committee is combing the status of registered products of radio frequency beauty medical devices at home and abroad，And on the basis of domestic and foreign classification policies on RF beauty products，According to the technical characteristics of radio frequency and the degree of risk of its products，In accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Medical Device Classification Rules" (Order No. 15 of the State Food and Drug Administration), "Medical Device Classification Catalog", etc., the "Principles of Classification and Definition of Radio Frequency Beauty Products" were compiled。
The principles for defining specific attributes are as follows：
(1) The expected use of radio frequency energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue, etc.)，Achieve local superficial mild heating、RF beauty products for improving blood circulation and other purposes，Should be in accordance with medical device management；
(2) The expected use of radio frequency energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue, etc.)，Make human tissue、Pathological/physiological changes in cells，And may cause potential impact or damage to the human body (such as edema、erythema、scald、Micro scar、Subcutaneous fat necrosis collapse and other clinical diseases) radio frequency beauty products，Should be in accordance with medical device management；
(3) Directly used for (including but not limited to) fat dissolving、Shaping、Scar treatment、Clearly change skin texture and other clear medical treatment behaviors，And may cause potential impact or damage to the human body (such as immediate tissue contraction response)、Tissue degeneration、Apoptosis, etc.) radio frequency beauty products，Should be in accordance with medical device management。
Industry insider Li Youzun said in an interview with Nandu reporter，At present, the treatment principle of most home beauty instruments on the market is low-energy radio frequency laser，To put it bluntly, it is a reduced version of thermage、Zelati，Will play a role in firming and lifting，But it will be effective if you insist on using it。But it’s not that low-energy radio frequency lasers and beauty devices can be equal，Because there are some beauty instruments that use the principle of traditional physical massage，Requires micro-current to operate。
Management categories according to the degree of risk
Not lower than class Ⅱ
The "Draft for Comments" also pointed out，According to the risk level of RF beauty products，Its management category should not be lower than Class Ⅱ。For specific products，Should be based on "Medical Device Classification Rules" and "Medical Device Classification Catalogue"，And according to its intended purpose、Comprehensively determine its management category based on factors such as use mode。
Southern Metropolis reporter noticed，This time there are products managed in accordance with Class II medical devices，Refers to the use of radio frequency energy to reach only the dermis，Achieve local superficial mild heating、The purpose of improving blood circulation，Does not damage the tissues below the dermis，Does not cause immediate tissue contraction response、Tissue/cell degeneration、RF beauty products with irreversible thermal injury reaction (scald reaction above degree I)。
And there are products that need to be managed in accordance with Class III medical devices。The first is to use radio frequency energy to act below the dermis、Cavity、Mucosa，Or use traumatic treatment (the treatment process and after treatment may cause skin breakage)，Make human tissue、Pathological/physiological changes in cells，And may cause potential impact or damage to the human body，Such as edema、Damage to skin barrier function (dry skin、sensitive)、Obvious pain、Scald reaction above first degree (obvious erythema reaction)、Pigmentation、Scar formation、RF beauty products such as blister formation。
Secondly, it is directly used (including but not limited to) to dissolve fat、Shaping、Scar treatment、Clearly change skin texture and other clear medical treatment behaviors，And may cause potential impact or damage to the human body，Immediate tissue contraction、Tissue degeneration、Apoptosis、High-energy radio frequency beauty products for irreversible physiological phenomena such as ablation and coagulation。
According to the Order of the State Food and Drug Administration (No. 15)，Medical device risk level，Is based on the intended purpose of the medical device，Through structural features、Use form、status of use、Comprehensive determination of whether it is in contact with the human body or other factors。Medical devices according to the degree of risk from low to high，Management categories are divided into the first category、Type 2 and Type 3。
Li Youzun said，At present, a major trend in the country is that the control of medical devices including radio frequency beauty equipment is becoming more and more stringent.，Radio frequency beauty includes radio frequency equipment in hospitals，Like Hot Maggie，Relati。Also includes home radio frequency beauty products，Like a beauty instrument，Hair growth instrument，Eye beauty equipment, etc.。The control of this piece of the country is gradually becoming more formalized，Because some medical institutions，No beauty salon has a qualification certificate，Not rigorous operation，Irregular，Cause all kinds of problems。And after formalization, it is also a kind of protection for patients。
53 days ago
You can send the "Consultation Form"
Notification indication，According to the requirements of the State Drug Administration，Leaded by the Medical Device Standards Management Center of the State Drug Administration，In conjunction with the Physiotherapy Device Professional Group of the Medical Device Classification Technical Committee, researched and compiled the "Guidelines for the Definition of Radio Frequency Beauty Products Classification"，Formation of the draft and preparation instructions。Open for comments。
Picture source "Medical Device Standards Management Center of the State Drug Administration" official website。
Relevant units or individuals can send the "Consultation Form" to the email flmsc@nifdc.org.cn before May 3, 2021。Please indicate the name of the feedback unit or individual in the subject of the email。
