Time : 2021-05-28
Source : CIRS
Author : CIRS
On April 16, 2021, the National Medical Products Administration released the "Guiding Principles for the Classification and Definition of Radio Frequency Beauty Products" for comments on the solicitation of "Guidelines for the Classification of Radio Frequency Beauty Products". According to the definition of the properties of the draft, it claims that radio frequency beauty can reduce spots and wrinkle. Such equipment is classified as medical device management. Medical device registration certificates must be provided when medical device products are sold on the platform, and registration certification documents must be provided on the product details page. If the product registration certificate has not been obtained after the official release of the classification definition guidelines, product sales may be affected. Therefore, manufacturers of radio frequency beauty instrument should start to formulate a registration plan now to prepare for the legal sale of subsequent products.
Which radio frequency beauty products belong to medical device management?
1) Radio frequency beauty products that are expected to use radio frequency energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue, etc.) to achieve local superficial gentle heating, improve blood circulation, etc., should be managed in accordance with medical devices;
2) It is expected that the use of radio frequency energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue, etc.) will cause pathological/physiological changes in human tissues and cells, and may cause potential impact or damage to the human body (such as edema, erythema) , Scalds, micro scars, subcutaneous fat necrosis and collapse and other clinical diseases) radio frequency beauty products should be managed in accordance with medical devices;
3) It is directly used for (including but not limited to) fat dissolving, shaping, scar treatment, obvious change of skin quality and other clear medical treatments, and may cause potential impact or damage to the human body (such as immediate tissue contraction response, tissue degeneration) , Cell apoptosis, etc.) radio frequency beauty products should be managed in accordance with medical devices.
Product management category of radio frequency beauty medical equipment
Medical device products comprehensively determine the management category of the product according to its intended purpose, product risk, etc. For radio frequency beauty equipment, the depth of energy reach, the damage and the intended use are the keys to distinguish the management category. The specific distinctions are as follows:
According to Class II equipment management: using radio frequency energy to reach only the dermis layer, achieving the purpose of local superficial gentle heating and improving blood circulation, without damaging the tissues below the dermis layer, without causing immediate tissue contraction, tissue/cell degeneration, and irreversibility Radio frequency beauty products for thermal injury reaction (scald reaction above degree I).
According to the management of Class III devices:
Use radio frequency energy to act below the dermis, cavity, mucous membrane, or use traumatic treatment (the treatment process and after treatment may cause skin damage), causing pathological/physiological changes in human tissues and cells, and may cause damage to the human body Potential impact or damage, such as edema, damage to the skin barrier function (dry, sensitive skin), obvious pain, burn reaction above first degree (obvious erythema reaction), pigmentation, scar formation, blister formation, etc. RF beauty products ；
It is directly used for (including but not limited to) fat-dissolving, shaping, scar treatment, obvious change of skin quality and other clear medical treatments, and may cause potential impact or damage to the human body, such as immediate tissue contraction response, tissue degeneration, cell High-energy radio frequency beauty products for irreversible physiological phenomena such as apoptosis, ablation and coagulation.
Class II products are reported to the Food and Drug Administration of the province where the manufacturer is located, and Class III products are reported to the State Food and Drug Administration.
regulatory differences between medical devices and ordinary home appliances
Medical devices have a complete regulatory system covering the entire product life cycle. It not only requires controllable quality at the production stage, but also has detailed management regulations for post-market sales, publicity, adverse events and recalls. Manufacturers should collect and learn about In accordance with relevant laws and regulations and notices, production and sales are organized. Special attention should be paid to the following points:
1. Supervision basis: You should understand the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Administration of Medical Device Registration", "Measures for the Supervision and Administration of Medical Device Production", "Measures for the Supervision and Administration of Medical Device Operation", "Administrative Measures for Medical Device Recalls", "Interim Measures for the Administration of Advertisement Review of Drugs, Medical Devices, Health Foods, Formulas for Special Medical Purposes" and other medical device-related laws and regulations.
2. Establishment of production quality management system: medical device manufacturers must meet the requirements of the GMP system, involving personnel, plant and facilities, equipment, documents, design and development, procurement, production management, quality control, sales and after-sales, control of unqualified products and defects Incident detection and other aspects. The GMP system requires companies to have at least 2 internal auditors (training required), manager representatives who are familiar with medical device laws and regulations and meet the educational requirements, and heads of technical, production, and quality management departments. They should have inspection equipment and should have Standardized personnel, training, operation records, and design and development documents should have traceable purchase, production, and inspection records, as well as the detection, analysis and improvement of adverse events. For specific assessment content, please refer to the "Medical Device Manufacturing Quality Management Specification Site Inspection guidelines. When registering a medical device product in China, the system verification is performed as part of the product registration inspection. The GMP certificate is not issued separately. If the product is approved for registration, it means that it complies with GMP management regulations; if the product is expected to be exported overseas, it is generally required to perform ISO13485 or GMP certification.
3. Advertising: The instructions for medical devices are prepared in accordance with the "Medical Device Instructions and Label Management Regulations". There should be no exaggerated and absolute descriptions in the instructions and labels. The functions such as light spot and wrinkle removal listed in the instructions should be used in the registration application. Submit the corresponding clinical trial report to prove the efficacy of the product, and the product should not have functions beyond the intended use. Medical device advertisements need to be filed, and the contents of the advertisements can be used for market promotion after approval, and false promotion is not allowed. The product registration certificate must be provided when medical devices are sold on the online platform and displayed on the detail page. Therefore, after the official draft of the guideline is issued, the sales of unlicensed radio frequency beauty instrument products on the platform may be restricted.
registration procedures and preparations for radio frequency beauty medical devices
1 technical documents
The product must formulate the technical requirements, instructions and labels for medical devices. The terms of the technical requirements are the full performance test items of the product, and the colleagues are also the attachments of the medical device registration certificate.
2 registration test
Product registration requires the submission of product test reports, which are mainly divided into performance testing, electrical safety testing and biological testing. The part of the material that is in direct contact with the human body should be subjected to biological testing. The testing items are evaluated according to 16886.1, generally three biological basic items; product performance and electrical safety testing items are the terms of the second part of the product technical requirements, and the testing should be sent to Qualified testing structure (with CMA, CNAS certification), pay special attention to electromagnetic compatibility and electrical safety must be tested in the same testing agency, otherwise the report is invalid.
3 clinical evaluation
According to the "Technical Guidelines for Clinical Evaluation of Medical Devices", products in the clinical exempt catalog can be exempted from clinical practice. Although Class II radio frequency beauty instrument can meet the requirements of 09-07-02, it is not in the clinical exemption catalog. Class III equipment is not in the medical equipment catalog, let alone the clinical exemption. Therefore, radio frequency beauty products are not in the clinical exempt catalog. In, clinical evaluation is inevitable. There are inevitably two paths for clinical evaluation of clinical products: comparison of the same species and clinical trials. To carry out clinical trials, it must be approved by the ethics committee and carried out in accordance with the clinical protocol to verify the clinical effects of the product's claimed functions such as lightening, wrinkle removal and solute, and finally submit a complete clinical trial report. Same-variety comparison refers to an evaluation method that proves the clinical effect of the product by comparing it with similar products that have been marketed and undergoing clinical trials. When applying for the same-variety evaluation, clinical trials are not required for the declared product, but the completeness of the comparison product must be submitted. Clinical trial report, and comparative analysis of declared products and similar products. Obtaining the clinical evaluation report of the comparative product requires the authorization of the other party, so the evaluation path of the same product is mainly applicable to the same group company.
The product registration application shall submit complete information in accordance with the requirements of the annex of Order No. 43 (Announcement of Medical Device Registration Application Information and Approval Document Format). In addition to the above-mentioned technical requirements specification, test report and clinical evaluation, it also includes various designs. And process verification, performance research data, risk evaluation data, etc. For details, please refer to the annex to Order 43.
For the registration of Class III medical devices, an electronic CA certificate is required, and the electronic registration materials shall be submitted to the State Food and Drug Administration for review by the National Instrument Inspection Center. Dossier review will take 5 working days. Dossier review will be formally accepted, and the review will begin after payment. The review will take 90 working days. The supplementary information sheet will be issued based on the completeness of the submitted materials. The company should supplement the release sheet within one year. If you do not supplement the information within the specified time limit, you need to re-apply and submit. For Type II products, submit paper or electronic application materials to the provincial Food and Drug Administration where the company is located. The review cycle is 60 working days. The specific procedures are slightly different according to the procedures of each province, but the basic requirements are the same.
Up to now, the registered radio frequency beauty medical devices are mainly large-scale equipment used in hospitals or beauty salons. Home beauty devices have not yet been approved for registration. The registrants are mainly overseas products, and there are few domestic registrants. The registered name of the product is mainly "Radio Frequency Therapeutic Apparatus" and "Easy for Radio Frequency Skin Treatment", and the intended use is indicated for facial or skin treatment.