Israel & the U.S. Market — Why FDA Compliance Matters
Israel has one of the world's highest concentrations of FDA-registered facilities per capita. Israeli pharmaceutical, biotech, and medical device companies are deeply integrated into the U.S. market — Israel is a top-10 source of FDA-regulated pharmaceutical imports to the United States by value.
Despite Israel's sophisticated regulatory environment and MOH/AMAR oversight, Israeli manufacturers must register separately with the FDA and designate a U.S. Agent. Israeli regulatory approvals do not substitute for FDA registration requirements.
Important: Israeli MOH (Ministry of Health) and AMAR (Medical Device & Cosmetics Division) approvals do not fulfil U.S. FDA requirements. Israeli pharmaceutical companies and medical device manufacturers must register separately with the FDA regardless of Israeli regulatory status.
Which Israel Products Require FDA Registration
The following Sri Lankan export categories require FDA registration and a designated U.S. Agent:
Pharmaceuticals, Generics & Biologics
Israel is a world leader in generic pharmaceutical manufacturing. Israeli drug manufacturers require annual CDER drug establishment registration, NDC Labeler Code, and U.S. Agent designation. Drug Master File (DMF) submission is commonly required for Israeli API and drug product manufacturers supplying U.S. companies.
Medical Devices & Diagnostics
Israel has a thriving medical device and in vitro diagnostic (IVD) sector. Israeli device manufacturers require annual CDRH establishment registration, device listing, and U.S. Agent designation. Many Israeli startups commercialising devices in the U.S. need FDA registration before their first sale.
Food, Kosher Products & Supplements
Israeli food manufacturers, kosher certified processors, and dietary supplement companies exporting to the U.S. require FDA Food Facility Registration and U.S. Agent designation. Israeli food and supplement products have a significant U.S. consumer base.
Cosmetics & Dead Sea Products
Israeli cosmetics — particularly Dead Sea mineral products and natural skincare — are popular in the U.S. market. Under MoCRA (2023), Israeli cosmetics manufacturers must register their facility with the FDA, list all products, and designate a U.S.-based Responsible Person.
The U.S. Agent Requirement for Sri Lankan Exporters
Every Israel facility registering with the FDA must designate a U.S. Agent — a person or company physically located in the United States. This is a legal requirement under 21 CFR; without a valid U.S. Agent your FDA registration will be rejected.
The U.S. Agent acts as the FDA's domestic point of contact for your Sri Lankan facility. They receive all official FDA communications on your behalf, assist with inspection coordination, and ensure critical notices reach you in time. Choosing the wrong U.S. Agent is one of the most common and costly mistakes Sri Lankan exporters make.
Regovant LLC is a trusted FDA U.S. Agent for Israel exporters, physically based in Casper, Wyoming USA. Learn about our U.S. Agent services →
How to Get FDA Registered as a Sri Lankan Exporter
Identify Your Product Category
Confirm whether your products fall under food, dietary supplement, medical device, drug, or cosmetics — each has different registration requirements and renewal timelines.
Designate a U.S. Agent
Select a physically U.S.-incorporated regulatory firm as your U.S. Agent. This is required before registration can proceed. Ensure they cover your specific product category.
Register in FDA's FURLS System
Your U.S. Agent submits your facility registration through the FDA Unified Registration and Listing System (FURLS). For food facilities, this includes your D-U-N-S number, facility details, and product categories.
Receive Your FEI Number & Certificate
Upon successful registration, the FDA issues your FDA Establishment Identifier (FEI) number. Your U.S. Agent delivers your official Certificate of Registration — the document your U.S. importers will request.
Maintain Compliance & Renew
Food facilities renew every 2 years (odd-numbered years: 2025, 2027). Medical devices, drugs, and cosmetics renew annually. Your U.S. Agent handles renewal reminders and submissions.
FDA Registration Costs for Sri Lankan Companies
The FDA itself charges no government fee for food facility registration, medical device establishment registration, or MoCRA cosmetics registration. The cost you pay goes entirely to your service provider for handling the registration on your behalf.
Regovant's fixed pricing for Sri Lankan exporters:
- Food Facility Registration + U.S. Agent + Certificate: $300/year
- Medical Device Establishment + U.S. Agent + Certificate: $550/year
- Drug Establishment + NDC + U.S. Agent + Certificate: $550/year
- Cosmetic Facility Registration (MoCRA) + Certificate: $650/year
- Additional food facility (same owner): $150/year
Note for Israel exporters: Many Israel facilities export multiple FDA-regulated product types. Each distinct product category may require separate registration. Regovant can assess your full product range and advise which registrations are actually required.
Why Israel Exporters Choose Regovant
Regovant LLC serves Israel exporters across multiple FDA product categories. We understand the specific compliance challenges Israel manufacturers face when entering the U.S. market.
FDA Registration for Israeli Manufacturers — From $300/Year
Regovant handles FDA registration for Israeli pharmaceutical companies, medical device manufacturers, food exporters, and cosmetics brands. MOH and AMAR approvals do not replace FDA registration — Regovant handles the complete U.S.-specific process.