Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Apostille for Israel
FDA Apostille for Israel
Israel has accepted apostilles since 14 August 1978. An FDA export certificate for Israel's Ministry of Health, an Israeli importer or a health fund needs a single U.S. Department of State apostille, with no Israeli consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 14 August 1978
- Apostilledocument route
- Hebrewofficial language
- 9 daysstandard processing
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time 9 business days
- No document shipping is required.
- You may update your own FedEx AWB or create a new one.
- Expedited processing times are offered.
- Credit card payments are accepted.
- The U.S. Department of State fee is already included.
- No separate U.S. Department of State form is needed.
- Track your order history and expenditures online.
Exp. Service fee$68 / Doc.
US Dept. of State fee$20 / Doc.
Total:$88 / Doc.
Why Israel Asks for an Apostilled FDA Certificate
Israel's regulators lean heavily on approvals from a small group of recognized jurisdictions, and the United States is one of them. Medical devices are a clear example. AMAR, the Ministry of Health's medical device unit, bases registration on prior approval in the U.S., Europe, Canada or Australia. A U.S. file typically includes the 510(k) clearance or PMA approval, an ISO 13485 certificate, and a Certificate to a Foreign Government or Certificate of Free Sale.
That makes the FDA certificate central to an Israeli submission, and the apostille is what lets Israeli authorities rely on it. Since the FDA is a federal agency, only the U.S. Department of State can apostille its certificates. We handle that step and ship the result to you or straight to your Israeli registration holder.
Which FDA Certificate Does Your Israeli Importer Need?
Match your product to the Israeli authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Israeli authority | FDA certificate |
|---|---|---|
| Medicines | Ministry of Health, Pharmaceutical Division | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | Ministry of Health, Medical Device Division (AMAR) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | Ministry of Health, National Food Service | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | Ministry of Health, National Food Service | Certificate of Free Sale (CFS) |
| Cosmetics & toiletries | Ministry of Health | Certificate for Cosmetics |
All of these product groups fall under Israel's Ministry of Health, each through its own division and procedure. Your Israeli registration holder will confirm which FDA certificate the relevant division expects for your product.
How the FDA Apostille for Israel Works
The Hague Apostille Convention has been in force for Israel since 14 August 1978, so a single apostille from the U.S. Department of State makes your FDA certificate valid there. There is no embassy visit, consular stamp or second legalization step.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Israel as the destination.
We review it
We check that the certificate is complete, FDA-signed and ready for the State Department.
State Department apostille
We submit it to the Office of Authentications and track it until the apostille is issued.
FedEx delivery
The apostilled certificate ships to you, your importer or your agent in Tel Aviv or anywhere else.
Exporting to Israel: What to Prepare
A local registration holder
Foreign manufacturers must appoint an Israeli representative to file with the Ministry of Health and hold the registration. Make sure the manufacturer and product names on your FDA certificate match the details your representative submits.
Health funds and hospitals
Being registered isn't the end of the process. Israeli hospitals and clinics order through the country's four health funds (Kupot Holim), and a fund may ask for samples or extra evidence before listing your device. An apostilled FDA certificate helps here too.
Electrical device testing
Some electro-medical devices also need validation by the Standards Institution of Israel (SII), which may ask for a sample and existing test reports. Plan this in parallel with the apostille, so neither holds up the other.
Hebrew and English
Hebrew is the official language, but Israeli regulators and companies routinely work with English documents. An FDA certificate in English is usually accepted as it is. Labels and patient information may still need Hebrew, so check with your representative.
FDA Apostille Cost for Israel
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88/ doc. | Standard processing: 9 business days. Expedited options available. |
FDA Apostille for Israel: FAQs
Is Israel a member of the Hague Apostille Convention?
Yes. Israel joined by accession, and the Convention has applied there since 14 August 1978. A U.S. Department of State apostille is enough, so no Israeli embassy or consulate legalization is needed.
Does AMAR accept U.S. FDA clearance for device registration?
Yes. AMAR bases medical device registration on prior approval in recognized jurisdictions, including the United States. A typical U.S. file includes the 510(k) or PMA letter, an ISO 13485 certificate, and a CFG or Certificate of Free Sale.
Which FDA certificate should I get for Israel?
A CFG or Certificate of Free Sale for medical devices, a CPP for medicines, a Certificate of Free Sale for dietary supplements, and a Certificate for Cosmetics for cosmetic products. Your Israeli registration holder will confirm the exact type.
Does my FDA certificate need a Hebrew translation?
Usually not. Israeli authorities commonly accept English documents. Product labels and patient information, however, may need Hebrew.
Do I need an Israeli representative?
Yes. Foreign manufacturers appoint a local representative to file with the Ministry of Health and hold the registration. We can ship the apostilled certificate directly to them.
How long does an FDA apostille for Israel take and what does it cost?
Standard processing takes 9 business days and costs $88per document: our $68 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
FDA Certificates We Apostille for Israel
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Apostilled for Israel
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
9 business days
- We accept credit card payments.
- Track your order history and expenses online.
- The U.S. Department of State fee is already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee
US Dept. of State fee
Total:
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