Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for Canada
FDA Apostille for Canada
Canada joined the Hague Apostille Convention on 11 January 2024. An FDA export certificate for a Canadian distributor, buyer or regulator now needs a single U.S. Department of State apostille, with no Canadian consulate step and no French translation for the certificate itself. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 11 January 2024
- Apostilledocument route
- English & Frenchofficial 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$65 / Doc.
US Dept. of State fee$20 / Doc.
Total:$85 / Doc.
Why Canada Asks for an Apostilled FDA Certificate
Until 2024, Canada was one of the few major trading partners of the U.S. that did not accept apostilles, so documents for Canada needed a longer authentication process. That changed on 11 January 2024. Today, when a Canadian distributor, hospital buyer, provincial agency or regulatory consultant asks for proof that your product is legally sold in the United States, an apostilled FDA certificate is all it takes.
Canada has its own regulators, and FDA approval doesn't give automatic access to the Canadian market. Health Canada licenses drugs and medical devices, reviews natural health products and receives cosmetic notifications, and the Canadian Food Inspection Agency (CFIA) oversees food imports. FDA certificates support those files and the buyer requirements around them. The FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We handle that and ship the result to you or your Canadian partner.
Which FDA Certificate Does Your Canadian Importer Need?
Match your product to the Canadian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Canadian authority | FDA certificate |
|---|---|---|
| Medicines | Health Canada, Health Products and Food Branch (Drug Identification Number) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | Health Canada (device licences for Class II–IV, MDEL for importers) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | Canadian Food Inspection Agency (CFIA), under the Safe Food for Canadians Regulations | Certificate to a Foreign Government (CFG), Health Certificate |
| Natural health products (supplements) | Health Canada, Natural and Non-prescription Health Products Directorate (NPN) | Certificate of Free Sale (CFS) |
| Cosmetics | Health Canada, Cosmetic Notification Form | Certificate for Cosmetics |
Canada runs its own approval and licensing systems, so an FDA certificate supports your file but never replaces a Health Canada licence or a CFIA requirement. Your Canadian importer or regulatory consultant will confirm what each recipient needs.
How the FDA Apostille for Canada Works
The Hague Apostille Convention has been in force for Canada since 11 January 2024, 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 Canada 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 Toronto or anywhere else.
Exporting to Canada: What to Prepare
Supplements are natural health products
Products sold as dietary supplements in the U.S. are generally regulated in Canada as natural health products. They need a product licence and an eight-digit Natural Product Number (NPN) before sale. An apostilled Certificate of Free Sale can support your evidence, but it doesn't replace the NPN.
Cosmetics: notify within 10 days
Cosmetics sold in Canada must be notified to Health Canada using the Cosmetic Notification Form within 10 days of first sale. Canadian buyers often ask for an apostilled FDA Certificate for Cosmetics as part of their supplier file.
Bilingual labels
Canadian labelling rules generally require English and French on consumer packaging. The FDA certificate itself doesn't need translating, but plan Canadian packaging alongside your apostille.
Importer licences
Food importers generally need a Safe Food for Canadians licence from the CFIA, and medical device importers and distributors need a Medical Device Establishment Licence (MDEL). Make sure the company names on your FDA certificate match your Canadian partner's licence.
FDA Apostille Cost for Canada
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $65 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $85/ doc. | Standard processing: 9 business days. Expedited options available. |
FDA Apostille for Canada: FAQs
Does Canada accept apostilles?
Yes, since 11 January 2024, when the Hague Apostille Convention entered into force for Canada. A U.S. Department of State apostille is now enough for FDA certificates used in Canada.
What did Canada require before 2024?
Before January 2024, Canada didn't accept apostilles, so U.S. documents went through a longer authentication and legalization process. That process is no longer needed for documents covered by the Convention.
Does FDA approval let me sell in Canada?
No. Canada has its own regulators. Drugs, devices and natural health products need Health Canada licences, cosmetics must be notified, and food imports follow CFIA rules. An apostilled FDA certificate supports these files and buyer requirements.
Does my FDA certificate need a French translation?
Usually not for the certificate itself. Canadian authorities and businesses work in English or French. Consumer packaging, however, generally needs both languages.
Which FDA certificate do Canadian buyers ask for?
A CPP for medicines, a CFG for medical devices and conventional foods, a Certificate of Free Sale for natural health products, and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.
How long does an FDA apostille for Canada take and what does it cost?
Standard processing takes 9 business days and costs $85per document: our $65 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
FDA Certificates We Apostille for Canada
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 Canada
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $85per 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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