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Just as Chinese foreign trade export companies were busy studying and cooperating with the destination country to prepare various certifications, an official statement from the U.S. Food and Drug Administration (FDA) shocked all foreign trade logistics companies planning to export epidemic prevention materials to the United States!
All “FDA registration certificates” on the market are fake! All are forged!
Three pieces of information were revealed to us in the official FDA announcement:
1. FDA will not issue registration certificates to medical device companies;
2. FDA does not certify the registration and listing information (listed products) of companies that have been registered and listed;
3. The company’s registered and listed products do not mean that the company or its equipment has been approved.
We can get a-few news from this announcement:
1. Most people say that foreign trade companies that can help you apply for FDA registration are cheating you;
2. Most of the so-called companies with FDA certification are unreliable (I will talk about the reason later);
So what are the FDA’s points that need our attention?
1. FDA has no certificate;
Answer: If your product has been certified and registered with the FDA in the United States, then you will get a certification registration code given to you by the FDA. This registration code is signed and authorized by the chief executive instead of giving you an FDA certificate to hang on the company.
2. FDA is not a service agency, but a law enforcement agency;
Answer: FDA is an enforcement agency, not a service agency. If someone says that they are a certified laboratory under the FDA, they must be lying to you.
Because the FDA has neither public-facing service certification agencies and laboratories nor so-called “designated laboratories.”
As a federal law enforcement agency in the United States, the FDA cannot engage in such things as both a referee and an athlete. The FDA will only recognize the GMP quality of service testing laboratories, and issue certificates of conformity if they are qualified, but will not “designate” or recommend a specific one or several to the public.
3. Americans must certify FDA certification;
Answer: If you want to do FDA certification, then your agent must be an American. People from other countries are not recognized. In other words, if a company tells you, they do it themselves FDA certification, and if he is not an American, then he must be lying to you.
It should be noted that the American must be a U.S. citizen or company because their existence is to help you communicate with the FDA, which is equivalent to an intermediary and must pass through this intermediary.
4. How to check whether the FDA certification is authentic;
Answer: Go to the FDA official website and enter the relevant information for inquiry.
https://www.fda.gov/ (FDA official website)