FDA registration

What is FDA registration

FDA registration can also be called FDA registration, which means that products such as cosmetics, medical equipment, food, lasers, LED lamps and other products exported to the United States must be registered with the US Federal Food and Drug Administration and ensure that the products comply with relevant US standards and health and safety requirements In order to successfully register some products, relevant inspections must be issued.

For example, clinical Class II and Class III medical products must provide 510K documents before they can be registered with the FDA.

Common misunderstandings of FDA registration:

  1. FDA registration is different from CE certification. The model of his certification is different from the product inspection + report certificate model of CE certification. FDA registration actually uses the integrity declaration model, that is: you are responsible for your products complying with relevant standards and safety requirements , And register on the US federal website, if the product has an accident, then you must bear the corresponding responsibility.

Therefore, for most products, FDA registration does not include sending samples for testing and issuing certificates. Therefore, there is a lot of publicity on the Internet. Wahaha obtained FDA certification and Quanjian products obtained FDA certification to show the safety of their products. Misunderstanding, there is no such thing as a high-end FDA.

  1. FDA registration validity period:

The FDA registration is valid for one year. If it exceeds one year, you need to resubmit the registration and the annual fee involved also needs to be repaid.

  1. Is there a certificate for FDA registration?

In fact, all actions of FDA registration are registered online, and there is no certificate. So what is the FDA certificate circulating on the market? In fact, it is a declarative document issued by the agency to prove that the product has been registered with the FDA. like:

What is the difference between FDA registration, FDA testing, and FDA certification can be understood in this way. FDA testing generally targets these types of products:

  1. Class II and III medical devices;
  2. Cosmetics, daily necessities;
  3. Food contact materials;

FDA registration is generally divided into:

  1. Cosmetics FDA registration
  2. FDA registration for LED and laser products
  3. FDA registration of medical devices
  4. Food fda registration
  5. Drug FDA registration

FDA certification is the collective term for FDA testing and FDA registration. Both can be called FDA certification. FDA certification is just a colloquial term.

New Trends in FDA Registration

Recently, LED lights will be included in the scope of FDA supervision. It is understood that after the implementation of this rule, LED light products may face a double “checkpoint” review. In addition to customs clearance, FDA clearance may also be required for customs clearance. However, this change only involves the LED lamp itself, and does not involve products that use the LED lamp (such as lamps without the LED lamp itself).

According to industry insiders, LED lights are included in the scope of FDA supervision, and the requirements for the export logistics industry will be more stringent. When receiving customer goods, they need to understand the manufacturer and refuse to accept irregular products. At the same time, when providing customs clearance materials, the information of the manufacturer of the LED light must be provided together, including the manufacturer’s name, address and contact number, so as to avoid delays in customs clearance.

It is reported that if you only use LED lights but do not have LED lights, please clearly mark it clearly in the customs clearance materials.

How to charge for FDA certification:

Generally, registration is free, but there will still be agent fees, because it is impossible for an American agent to help a Chinese company as an agent for free, that is, a third-party contact person. How much does it cost to do fda certification for a product, presumably a lot Everyone wants to know, but the price should be quoted according to the product to be made and the type of certification, depending on the product. For detailed quotation, please consult the TCT testing engineer!

FDA certification process:

  1. The applicant signs the “FDA Registration Quotation Contract” and fills in the “FDA Registration Application Form”;
  2. The applicant will send the application form and contract back to us after being stamped;
  3. TCT sends payment notification;
  4. The applicant pays the registration fee;
  5. TCT applies for registration with FDA;
  6. The applicant receives FDA registration related materials (FDA registration number, password, PIN code and other related information)
  7. Acceptance of application for preliminary technical review
  8. DMF data review
  9. FDA inspection
  10. FDA issues “Letter of Approval”