FDA registration and approval guide for Indian pharmaceutical, food, and medical device exporters. Process, documentation, fees, and compliance requirements explained.
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US FDA (Food and Drug Administration) Registration & Approval is a mandatory regulatory requirement for Indian manufacturers and exporters seeking to export food, pharmaceuticals, medical devices, and cosmetics to the United States. The FDA, operating under the Federal Food, Drug, and Cosmetic (FD&C) Act, requires foreign manufacturers to register their facilities and obtain product-specific approvals or clearances before their goods can enter US commerce. For Indian EXIM entities, this process involves submitting detailed facility and product information to the FDA's established systems, including the Food Facility Registration (FFR) for food items and the Drug Establishment Registration (DER) for pharmaceuticals.
Unlike the Indian regulatory framework governed by the FTDR Act and FSSAI Act, FDA registration is a US-centric requirement that operates independently. Indian exporters must navigate the FDA's digital platforms, comply with Current Good Manufacturing Practice (CGMP) standards, and maintain meticulous documentation. Registration is distinct from approval—while registration establishes the facility's legitimacy, product approval (particularly for pharmaceuticals and medical devices) requires additional clinical or safety data submission and FDA evaluation.
| पैकेज | कीमत | विवरण |
|---|---|---|
| Standard | On request | Including document prep |
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