Food and Drug Administration: Omni-directional Strengthen Beauty Cosmetic Supervision

Strengthen source management

Most of the medical devices used by beauty agencies are high-risk medical devices, such as implantable devices, disposable devices, and large-scale imported medical devices. These types of devices are key regulatory types. The food and drug supervision departments must increase the management of production, import, sales, and use of products, eliminate the flow of unlicensed products to the market, and put the “suspected products” supervised. There are still many “suspected” cosmetic medical devices similar to “Beauty Gold Wire” on the market. Food and drug regulatory authorities are required to actively intervene in this kind of certificate of not obtaining medical device registration. Their functions are covered by the definition of medical devices, but It also does not include the supervision of products in the current medical device catalog. In addition, it is necessary to strictly require that production, sales, and use units have quality management personnel with certain qualifications, strengthen the management of posts and training of such personnel, so that relevant units fully recognize the high risk of cosmetic medical device products, and regulate their Quality Control.

Highlight day-to-day management

First, enterprises are strictly required to legally produce, purchase, and use medical devices in accordance with the "Regulations on the Supervision and Administration of Medical Devices," and must not produce, sell, or use medical devices that have no product registration certificate, no certification, expiration, expiration, or elimination. Secondly, operators must strictly implement the medical device purchase acceptance system, truthfully record the details of production, sales, purchase, and use of medical device names, specifications, manufacturers, and production dates, and save the purchase invoices as required. To match the bills. Third, we must establish high-risk medical device use files. Operators must establish client files for the use of high-risk cosmetic instruments such as hyaluronic acid injections, botulinum toxins, hyaluronic acid and collagen, syringes for silicone (breast fillings), artificial chin prostheses, etc. Into the material management requirements, a detailed record of each implanted material in the surgical process and user information, etc., and keep relevant evidence for future reference to ensure that the source. Fourth, we must strengthen the use and management of large-scale medical equipment. It is necessary to increase the supervision and inspection of the use and management of cosmetic large-scale medical equipment, such as special suction machines for liposuction surgery, light quantum generators, etc., and to inspect the quality of products and the quality of supporting products, strictly implement the procedures for cleaning and maintenance, and ensure the legality of consumers. rights and interests.

Establish a safety tracing mechanism

Safeguarding consumers' safe use of medical devices is the starting point for regulatory work. From the cases of cosmetic medical devices such as “Aomeiding” and “Beauty Gold Silk,” it can be seen that only by establishing a medical device adverse event monitoring system and emergency response mechanism can a timely warning message be issued to the society to prevent more victims from appearing. . Therefore, we must strengthen the monitoring of cosmetic medical device key varieties, and focus on the collection, analysis, and evaluation of information on adverse events in implantable high-risk medical devices so that appropriate control measures can be taken to avoid adverse events. Second, we must strictly implement the recall management regulations. For early warning information fed back by the market, effective measures shall be taken in time, information collection and analysis shall be strengthened through various means, and correct administrative decisions shall be made after comprehensive evaluation. For products that need to be recalled, it is necessary to take decisive measures and issue recall announcements to reduce the risk of harm. Third, it is necessary to play the role of reporting complaints, increase laws and regulations, improve the reporting system, report complaints to the public, implement reporting incentives, mobilize consumers to participate in supervision, strengthen case investigation, and strengthen cosmetic medical devices. Supervision.

Always maintain high pressure

Increase supervision and inspection efforts. In strict accordance with the requirements of relevant laws and regulations for medical devices, efforts are made to strengthen the supervision of cosmetic medical device products, increase the sampling of cosmetic medical device products and exposure of counterfeit and inferior products, and severely investigate and deal with violations according to law.

To carry out special rectification work. Beauty-related medical devices involve a wide range of features, are complex in performance, and have a strong concealment of the use of objects. It is not possible to obtain control effects through one or two special inspections. Therefore, only by regularly carrying out special rectification work for such products, and always maintaining a high pressure of cracking down on bad governance, can we promote further improvement in the cosmetic medical device market and promote the healthy and orderly development of the entire industry.

Strengthen the construction of credit system. Gradually establish the evaluation system of beauty institutions' credibility, form the beauty and quality of medical devices, and regularly publish the information on corporate integrity and product sampling to the public through the media, increase the company’s untrustworthy costs, and guide social rational consumption.