How to get USFDA Import License – how do you get a fda license – regpro.us

Obtaining a USFDA (U.S. Food and Drug Administration) import license involves several steps to ensure that products meet the regulatory requirements of the United States. Click here to proceed

1. Determine the Product Category

Different products are regulated differently. Common categories include:

Food and beverages
Dietary supplements
Drugs and pharmaceuticals
Medical devices
Cosmetics
Tobacco products

2. Register Your Facility

Depending on the product, our USFDA agent will register your manufacturing facility with the FDA:

Food Facilities: Register under the Food Safety Modernization Act (FSMA).
Drug and Device Facilities: Register under the Drug Registration and Listing System (DRLS) and the Device Registration and Listing System (DRLS).

3. Comply with FDA Regulations

Our team ensures your product complies with all applicable FDA regulations:

Labeling Requirements: Ensure labels meet FDA requirements.
Good Manufacturing Practices (GMP): Follow GMP guidelines for production.
Product Approval: Some products, such as drugs and medical devices, require pre-market approval or clearance.

4. File Required Documents

Our USFDA agent ask for the necessary documentation for submitting to the FDA:

Prior Notice for Food Shipments: Submit prior notice before food is imported.
Entry Documents: Provide entry documents to U.S. Customs and Border Protection (CBP).

5. Work with a Customs Broker

Our team engages a customs broker to assist with the import process, including:

Preparing and submitting import documentation.
Facilitating communication with the FDA and CBP.

6. Conduct a Compliance Review

Our team ensures your products meet U.S. safety and labeling standards:

Inspection: Be prepared for potential inspections by the FDA.
Testing: Ensure products are tested as required.

7. Follow Up on Your Application

After submission, our USFDA agent monitors the status of your application and responds promptly to any FDA inquiries.

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