FDA REGISTRATION

WHAT IS THE FDA?

The Food and Drug Administration (FDA) is a regulatory agency of the U.S. Department of Health and Human Services (HHS) responsible for overseeing and regulating food, pharmaceuticals, cosmetics, medical devices, and other health-related products in the United States.

The primary mission of the FDA is to protect and promote public health by ensuring that products marketed in the United States meet established standards of safety, quality, and effectiveness. The FDA ensures that these products are properly researched, developed, manufactured, and used in a manner that safeguards consumer health and well-being.

The FDA also plays a critical role in the evaluation, regulation, and monitoring of the manufacturing, importation, distribution, and use of medical products and food products within the United States.

WHICH PRODUCTS ARE REQUIRED TO REGISTER WITH THE FDA?

When exporting goods to the United States, the following categories of products are generally required to complete FDA registration or comply with applicable FDA regulatory requirements:

1. Food products
2. Pharmaceuticals (drugs)
3. Medical devices
4. Radiation-emitting products
5. Vaccines, blood products, and biological products (biologics)
6. Animal feed and pet food
7. Cosmetics
8. Tobacco products

FDA REGISTRATION SERVICE AT KMR VIETNAM

Sample of an FDA Certificate

The U.S. Food and Drug Administration (FDA) does not issue certificates for food, pharmaceutical, cosmetic, or medical device facilities. Instead, the FDA assigns registration numbers through its electronic registration systems. The purpose of these FDA registration numbers is to identify and manage registered establishments, not to certify the quality or standards of the facility or the registered products.

In practice, an FDA Registration Certificate may be issued by U.S. agents or consulting organizations to confirm that a company has successfully completed registration within the FDA system.

A sample FDA Registration Certificate issued by our U.S. FDA agent is provided as follows:

FDA Registration Process

1. The company provides FDA registration information to KMR Vietnam (according to the registration form).
2. Preparation and review of required documentation.
3. KMR coordinates with an authorized U.S. FDA Agent.
4. Submission of registration to the FDA electronic registration system.
5. Confirmation of registration and issuance of the FDA registration certificate.

FDA Registration Timeline

The registration timeline depends on the type of product and whether the company has prepared all required documentation and information:

• FDA registration for food facilities: 2–3 days
• FDA registration for cosmetics: approximately 30 days
• FDA registration for medical devices: approximately 90 days

After Successful FDA Registration, the Company Will Receive

The FDA Registration Package includes:

• 01 FDA Registration Certificate
• 01 FDA-issued facility registration number
• 01 electronic account for managing the registration on the FDA official system