Indian spices, ready-to-eat foods, Ayurvedic and personal-care products, medical devices and generics are in demand in the US. They all pass through the U.S. Food and Drug Administration. An unregistered facility, a missing US Agent or a non-compliant label is enough to get a shipment detained. PCN sets up your FDA registration, listings and renewals and keeps them current.
| Food, spices, beverages, supplements | Food facility registration (renewed every even-numbered year, 1 Oct–31 Dec); US Agent; Prior Notice before each shipment; US-format labels |
|---|---|
| Medical devices & IVDs | Annual establishment registration and device listing with user fee; US Agent; 510(k)/De Novo/PMA where required; QMSR aligned with ISO 13485 |
| Cosmetics & personal care | MoCRA facility registration and product listing; safety substantiation; labelling |
| Drugs & APIs | Drug establishment registration, NDC listing, DUNS, US Agent, cGMP readiness |
Food facility registrations must be renewed between 1 October and 31 December 2026. Registrations not renewed in that window are treated as expired, and shipments can be refused. PCN can renew yours or check its status.
No. FDA doesn’t issue registration certificates, so be wary of anyone selling “FDA certificates”. You receive a registration number, and product approval applies only to certain devices and drugs.
Yes, if they are physically in the US and agree to act as your point of contact with FDA. Professional US Agent services are also available.
They show regulatory maturity, but they don’t replace FDA registration or US labelling and quality-system requirements.
Facility registration can be completed within days once documents are ready. A 510(k) takes months.
Requirements, portals and fees change often. PCN confirms the applicable rules for each product before quoting. Certificates are issued by the relevant authority, accredited certification body or notified body.
Send your product name, HS code and destination. Our Delhi team will confirm the route, testing and timeline within 48 hours.
📞 +91 80109 05029 · ✉️ bdm@pcnindiaglobal.com
Related: USA Certification · FCC · CDSCO (India) · Legal Metrology LMPC (India) · EU Certification
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