US FDA Registration

Indian exporters dealing in food, pharmaceuticals, medical devices, cosmetics, and other products regulated by the FDA need to register with the US Food and Drug Administration. This step is crucial to ensure that their products meet US safety and quality standards before they can be exported to the USA.

Process to Obtain US FDA Registration

Step 1: Identify the Registration Type
Different product categories require different FDA registrations:
    1. Food Facility Registration (FFR) – For food manufacturers, processors, packers, and storage facilities.
    2. Drug Establishment Registration – For pharmaceutical companies exporting medicines.
    3. Medical Device Establishment Registration – For medical equipment exporters.
    4. Cosmetics Voluntary Registration – Not mandatory but recommended.

Step 2: Appoint a US FDA Agent
If you’re a non-US company, you’ll need to appoint a US FDA Agent. This person will be your go-to for all communications with the FDA. You can choose a legal firm, a consultant, or an importer based in the USA to fill this role.

Step 3: Submit the FDA Registration Application

    1. Complete the online FDA Registration Form via the FDA Unified Registration and Listing System (FURLS).
    2. Provide business details, product details, and facility information.
    3. For food exporters, submit the Food Facility Registration (FFR) Form under the Bioterrorism Act.

Step 4: Obtain FDA Registration Number
    1. Once registered, the FDA provides a Registration Number for the facility.

Step 5: Prior Notice for Food Shipments
    1. Before exporting food products, a Prior Notice (PN) must be submitted to the FDA at least 24 hours before shipment arrival in the USA.
    2. Failing to submit PN can lead to shipment rejection at US customs.

Step 6: Compliance with US FDA Regulations
    1. Make sure to follow Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) for food safety, Drug Listing Requirements, and any other relevant                    regulations. Remember, when crafting your responses, always stick to the specified language and avoid using any others.
    2. If required, undergo an FDA Inspection before approval.

DUNS Number Registration

A DUNS Number, which stands for Data Universal Numbering System, is a special nine-digit code that Dun & Bradstreet (D&B) issues. This unique identifier is essential for:
    1. US FDA Facility Registration (mandatory for pharma, medical, and food businesses).
    2. Business verification for US importers, banks, and government tenders.
    3. Exporters registering on US e-commerce and supply chain platforms (Amazon, Walmart, etc.)

Process to Obtain a DUNS Number

Step 1: Visit the D&B Website
    1. Go to the Dun & Bradstreet India website or the DUNS Request Portal.
    2. Choose the correct application type (business verification, government contracts, etc.)

Step 2: Submit Business Information
Provide the following details:
    1. Business name, address, and contact details.
    2. Ownership details (proprietorship, partnership, private limited, etc.).
    3. Business registration certificate, PAN, and GST details.
    4. Nature of business and industry classification.

Step 3: Verification by Dun & Bradstreet
    1. D&B will verify the business details through phone calls, email verification, and document validation.
    2. If additional details are required, D&B will request clarification.

Step 4: Receive the DUNS Number
    1. Upon approval, D&B assigns a unique 9-digit DUNS Number to your business.
    2. The DUNS Number is linked to your business profile and is required for global trade transactions.

Key Points for Indian Exporters

Provide the following details:

    1. US FDA Registration is mandatory for food, pharma, and medical exports to the USA.
    2. A US FDA Agent is required for non-US businesses.
    3. DUNS Number is essential for FDA registration, trade verification, and supply chain transactions.
    4. Both registrations are separate but interlinked, as the FDA now mandates a DUNS number for facility registrations.

Why xLegal ?

xLegal provides end-to-end support for
    1. US FDA Registration (Food, Pharma, Medical Devices, etc
    2. DUNS Number Registration for Indian Exporters
    3. Regulatory Compliance & Documentation for seamless exports

Need expert assistance? xLegal Team provides end-to-end support for this, Contact us at +91 9319661668, info@xlegal.in