Authority certification slogan

Talk? FDA certification? Many consumers will be familiar with it, but they don't know its details. FDA (American Food and Drug Administration) is a government department that supervises and manages American food, drugs, cosmetics and medical devices according to relevant laws and regulations. According to the medical use and possible harm to human body, FDA classifies medical devices into I, II and III. The higher the category, the more supervision.

It has been introduced in the article from the media that only products with the highest risk level above Class III that are not exempted from 5 10K can apply for FDA registration? Has the FDA approved it? . Three-pole stop product, namely rf beauty instrument, should belong to the second kind of medical devices, what should be obtained? Marketing license (FDA approval)? Instead of. Certification? , then is there? False propaganda? Suspected.

Nanjing Jaguar explained that if it is a brand-new technology, it has not been recognized or approved by the FDA before. If it is proved to be safe and effective in pre-marketing clinical trials, it will be approved by the FDA. If other products use the same technology, it will be approved by FDA after proving to FDA that the composition, technology, parameters and other factors of the product are as safe and effective as those approved by FDA.

Therefore, Nanjing Jaguar believes that TriPollar Stop is a kind of RF technology used in products, which has been approved by FDA in previous products, so it will be used in the description of this series of products. Has the Food and Drug Administration approved it? Call it acquisition? Technical certification? No problem. The company believes that the fuzziness of relevant descriptions is a problem of academic debate and translation, and it is not intended to distort the facts.

In recent years, the demand for beauty instruments in China has increased by spurt. Due to the characteristics of products, it is conceivable that businesses attach importance to various test reports, qualifications and certifications. In all kinds of dazzling advertisements, there will inevitably be controversial voices.

In fact, what about the market? FDA certification? The statement has been concerned by professionals before. On June 5438+ 10 this year, Dongwei Chengdu Law Firm issued a document to interpret this.

According to the article of the Institute of Law, most of the FDA certification of household beauty instruments advertised in the market now means that they become Class II medical devices through the marketing license obtained by 5 10K. The domestic beauty instrument passed the FDA's second-class medical device certification with the path of 5 10(k), which only means that the instrument is consistent with the existing instruments in terms of safety and effectiveness, and constitutes substantial equivalence, so it is allowed to be sold as a medical device in the US market.

That is to say, the market access permit (FDA Cleared) passed by the FDA through the 5 10(k) route can only be stated in the public notice? Compared with the existing instruments, is this instrument consistent in safety and effectiveness? And then what? It is allowed to be sold in the American market. . ? Therefore, if the promotion of products in FDA certification exceeds the above explanation, and the promotion language is inconsistent with the records in the application materials submitted to FDA, it is suspected of false promotion. ? Dongwei Chengdu Law Firm said.

So, what about the three-pole related products on the Tmall platform? Its products have obtained FDA 13 technical certification? Is the slogan suspected of exceeding the above explanation?

In this regard, China Economic Weekly called 65438 Nanjing Jaguar on the afternoon of February 28th and sent an interview letter. As of press time, no response was received from the other party.

What about Nanjing Jaguar? FDA certification? What measures can consumers take if they are officially identified as exaggerating propaganda?

Article 8 of China's Consumer Protection Law stipulates? Consumers have the right to know the real situation of the goods they buy or use or the services they receive; Article 55, paragraph 1? If an operator commits fraud in providing goods or services, it shall increase the compensation for the losses suffered by consumers as required, and the compensation amount shall be three times the price of the goods purchased by consumers or the cost of receiving services; If the amount of additional compensation is less than that of 500 yuan, it shall be 500 yuan. Where there are other provisions in the law, those provisions shall prevail. ?

According to the above provisions, if? Exaggerate propaganda? Established, the consumer bought TriPollar StopVx at the price of 4482 yuan on Tmall 65438+February 30th, and the merchant should not only refund 4482 yuan to the consumer, but also compensate the consumer 13446 yuan.