FDA is the abbreviation of U.S. Food and drug administration, which belongs to the U.S. Department of health, education and welfare. It is responsible for the management of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies. FDA is a government health regulatory monitoring agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists, statisticians and other professionals committed to protecting, promoting and improving national health. Food, drug, cosmetics and medical devices certified by FDA are safe and effective for human body. In nearly 100 countries such as the United States, only FDA approved materials, devices and technologies can be used commercially
Common problem
Question 1: which agency issued the FDA certificate?
A: there is no certificate for FDA registration. If the product is registered in FDA, the registration number will be obtained. FDA will give the applicant a reply (signed by FDA Chief Executive), but there is no FDA certificate.
Question 2: does FDA need a designated certified Laboratory for testing?
A: the FDA is a law enforcement agency, not a service agency. If someone says that they are FDA's Certification Laboratories, he is at least misleading consumers, because the FDA has neither public service certification bodies and laboratories, nor so-called "designated laboratories". As a federal law enforcement agency, FDA is not allowed to engage in such matters as both referee and athlete. FDA will only recognize the GMP quality of service testing laboratories, and issue certificates of compliance, but will not "designate" or recommend a specific one or several to the public.
Question 3: does FDA registration require an American agent?
A: Yes, the Chinese applicant must appoint a U.S. citizen (company / Society) as its agent when registering with the FDA. The agent is responsible for the process service located in the U.S. and is the media to contact the FDA and the applicant.
The import procedure is as follows
Within 5 working days after the arrival of the goods at the port of entry, the importer or agency shall fill in the entry documents with the U.S. customs service.
When FDA receives the entry notification, it will review the importer's customs declaration unit to determine whether physical inspection (terminal inspection, sampling inspection) should be carried out. If FDA decides not to take samples, it will send them to the U.S. Customs, the case and the importer respectively (renewal notification). At this time, this batch of goods will be released at FDA. Note that "can be continued without inspection" does not mean that the product meets the requirements. It only means that FDA does not inspect the product when it enters the country. If the product is found to be in violation of laws and regulations in the future, corresponding legal measures (such as confiscation, etc.) will be initiated according to the nature of the violation. If the FDA decides to take samples, it will send "sampling notice" to the U.S. Customs, the case and the importer respectively. The original samples of the goods must be kept for further notice, and the FDA will take samples from the goods.
Since its establishment, the company has been constantly improving the strength of the enterprise, and the industry qualification obtained is also among the best. If you need to apply for FDA registration for related products, you are welcome to call our staff at any time to obtain detailed cost quotation, cycle and other information. Shenzhen xunke technology testing agency has been engaged in testing and certification industry for many years, helping you to solve more testing and certification problems!