Questions about FDA registration

Export enterprise registration concerns

What issues do foreign export companies generally need to pay attention to when registering? The following is part of the contents organized by China Unicom for your reference:

Question 1: Which agency issued the FDA certificate?

Answer: There is no certificate for FDA registration. By registering the product with FDA, the registration number will be obtained. FDA will give the applicant a reply letter (signed by the FDA Chief Executive), but there is no FDA certificate.

FDA issued such a notice at this time is a strong reminder! Due to the recent development of the epidemic in the United States, the demand for medical anti-epidemic products to export to the United States has increased significantly, and the demand for export registration has also increased. However, there are some companies who pretend to be FDA and issue certificates to manufacturers. Some distributors obtain the "FDA" "Certificate" may also be counterfeit.

Question 2: Does the FDA need a designated certification laboratory for testing?

A: The FDA is an enforcement agency, not a service agency. If someone says that they are FDA-certified laboratories, he is at least misleading consumers, because FDA has neither a service-oriented certification body and laboratory for the public nor a so-called "designated laboratory."

As a federal law enforcement agency, the FDA cannot engage in such a matter of being a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue qualified certificates, but will not "designate" or recommend a specific company or companies to the public.

Question 3: Does the FDA registration require a US agent?

A: Yes, companies must designate an American citizen (company/society) as their agent when registering with the FDA. The agent is responsible for the process services in the United States and is the medium for contacting FDA and the applicant.

Common misunderstandings of FDA registration

1. The FDA registration is different from the CE certification. The certification model is different from the CE certification product testing + report certificate model. The FDA registration actually uses the integrity declaration model, that is: you are responsible for your products complying with relevant standards and safety requirements. , And registered on the US Federal website, if the product is in trouble, then it must bear corresponding responsibilities. Therefore, for most products, FDA registration does not exist for sending samples for testing and issuing certificates.

2. FDA registration validity period: FDA registration validity period is one year, if more than one year, you need to resubmit the registration, and the annual fee involved also needs to be repaid.

3. Is there a certificate for FDA registration?

In fact, FDA registration does not have a certificate. By registering the product with FDA, the registration number will be obtained. FDA will give the applicant a reply (signed by the FDA chief executive), but there is no FDA certificate. The certificate we usually see is issued to the manufacturer by an intermediary agency (registered agent) to prove that it helped the manufacturer complete the "Production Facilities Registration and Product Type Registration" (EstablishmentRegistration and DeviceListing) required by the US FDA. The completed mark is to help the manufacturer Obtained FDA registration number.

China Recognizance Testing Technology Co., Ltd. provides customers with CE certifications such as personal protective masks, N95 masks, FDA certifications, domestic quality inspection reports, and professional engineers to answer online for you. If you have questions or are unclear, you can contact Contact our company, companies in need can directly contact China Recognition for consulting related business.

Consultation hotline: 400-880-1556