FDA Certification & Registration
FDA compliance is mandatory for exporting regulated products to the United States. Xportise helps Indian exporters, manufacturers, and brands complete FDA registration, product listing, and compliance correctly — without false claims or legal risk.
What is FDA Certification?
US regulatory compliance, not a license
FDA (U.S. Food and Drug Administration) regulates products entering the United States, including food, cosmetics, medical devices, drugs, and dietary supplements.
FDA does not issue certificates or licenses in most cases. Compliance involves registration, product listing, facility approval, and adherence to US regulations.
Who Needs FDA Compliance?
Applies to specific product categories
Food & Beverages
Packaged food, beverages, nutraceuticals, and dietary supplements.
Medical Devices
Class I, II & III devices requiring registration or clearance.
Cosmetics & Drugs
Cosmetics, OTC drugs, and pharmaceutical products.
Documents Required for FDA Registration
Varies by product category
Business & Facility
- Company & manufacturing details
- Facility address & ownership
- US Agent details (mandatory)
Product Information
- Product composition & labeling
- Intended use & category
- Compliance declarations
FDA Registration Process
US FDA-compliant workflow
FDA does not “approve” or “certify” most products before sale. Misrepresenting FDA certification can result in shipment detention, warning letters, import refusal, or permanent bans. Always follow category-specific FDA regulations before exporting.
FDA Certification & Registration Fees
FDA compliance cost depends on product category, facility type, and U.S. regulatory requirements.
FDA Applicability & Compliance Assessment
- ✔ Identify FDA-regulated product category
- ✔ Check FDA registration vs approval requirement
- ✔ Facility & product compliance review
- ✔ Determine U.S. Agent requirement
- ✔ Estimated FDA cost & timelines
- ✔ Expert guidance before registration
FDA Registration – End-to-End Support
Complete FDA compliance support for U.S. market entry.
- ✔ FDA establishment registration
- ✔ Product listing (where applicable)
- ✔ U.S. Agent coordination
- ✔ Labeling & compliance checklist
- ✔ Prior Notice guidance (for food exports)
- ✔ Annual renewal & compliance reminders
- ✔ Export & customs readiness support
Do You Really Need FDA Certification?
FDA registration or approval is required only for specific products entering the United States market.
FDA is Required If You:
- ✔ Export food or beverages to the USA
- ✔ Export medical devices, cosmetics, or drugs
- ✔ Manufacture FDA-regulated products
- ✔ Sell FDA-regulated goods in the US
FDA is NOT Required If You:
- • Export non-regulated industrial goods
- • Sell only within India
- • Export to non-US countries
- • Send samples (case-specific)
After FDA Registration — What Happens?
Your product becomes eligible for legal entry into the US market.
FDA Facility Registration
Registration of manufacturing or processing facility with FDA.
Product Listing / Approval
Product listing or pre-market approval as per FDA category.
US Customs & FDA Clearance
FDA entry filing, customs review & shipment release.
FDA Certification / FDA Registration is mandatory for manufacturers and exporters supplying FDA-regulated products to the United States market. Businesses searching for FDA certification in Bangalore or FDA registration in India are typically exporters, manufacturers, food processors, cosmetic brands, medical device companies, and pharmaceutical suppliers planning to sell products in the USA. FDA compliance ensures that products meet US safety, quality, and regulatory requirements.
Xportise provides FDA certification and registration support in Bangalore (Bengaluru), Karnataka, and across India by assisting businesses with FDA facility registration, product listing or approval, US Agent coordination, labeling compliance, prior notice filing, and FDA readiness for US customs clearance. We support Indian exporters supplying food products, cosmetics, medical devices, dietary supplements, and FDA-regulated goods to the USA.
