How to export items subject to FDA to the U.S.

 

How to export items subject to FDA to the U.S.

---

 

FDA

 

If you are planning to sell your products to the U.S. market, and if you are informed that the products are subject to FDA review or need to be FDA certified, you will take time to find out how you can export to the U.S. market.

FDA is..   

First of all, the FDA stands for The United States Food and Drug Administration (U.S.). Like any Ministry of Food and Drug Safety in your country, certain products must be certified by the FDA for the safety of the American people to export to the United States.

Required Information

First of all, you need the information below to export the products subject to FDA review to the United States.

1) Manufacturer (DEV), Korean exporter (DFE), and FDA registration # of the U.S. importer

2) Device Listing Number (LST)

3) Premarket (510K) #, Good Manufacturing Practices (GMP), Quality System Regulation (QSR) - If necessary, the reference here is to be renewed in one year for Registration #. If you do not renew it, it will be deleted from the FDA Medical Device Registration and Listing website.

FDA Registration

In order to register a company or product with the FDA, the information will be sent via online. For example, I'll explain it to you with a medical device. There are two procedures for registering a medical device.

1. Paying for one year's registration

2. You have to go through the registration process.

The official registration will be done by the FDA Online Account Administration (OAA).

If you go to the site, you can see the screen above and if it's your first time registering, you can register with New User as "Create New Account."

How to verify if a drug and a company is listed on FDA

If your company has received FDA registration# and listing# for the product, let's see how to verify that the FDA has been properly listed.

First, go to the https://www.fda.gov/medical-devices site and scroll down, and you'll find links to search for a variety of things:

If you want to verify that your company's FDA registration # is properly registered, go to the site below.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Then you'll see the site above, and you can search by writing your own English company on the Establishment or Trade Name here and clicking the Search button.

You need to know for sure and prepare thoroughly...

Whatever happens, it's embarrassing and time consuming at first, but once you go through it, it's really nothing. It's a very difficult time around the world, and I hope the information above will be beneficial to many self-employed/business owners.

That's all for today.

---

Relevant Post [Please click the link below]

- [USA/Business] - Establishment of Corporation in the U.S. 

2020/10/29 - [USA/Business] - Establishment of Corporation in the U.S.

- [USA/Business] - The Way to Get a Free DUNS Number

2020/10/29 - [USA/Business] - The Way to Get a Free DUNS Number

- [USA/Business] - How to Complete W-8BEN-E Form

 

[USA] How to Complete W-8BEN-E Form

 

 

 

 

 

 

 

---