Precautions and Registration Preparations for Radio Frequency Beauty Products Transferred to Medical

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.

Registration review

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.