Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for Taiwan
FDA Embassy Legalization for Taiwan
Taiwan is not a party to the Hague Apostille Convention, and it has no embassy in the United States. FDA certificates bound for Taiwan's Food and Drug Administration are instead authenticated by TECRO, the Taipei Economic and Cultural Representative Office, after state and U.S. Department of State certification. We handle the whole chain and FedEx the finished document to you or your Taiwan agent in about 18 business days.
- Not in Hagueembassy legalization needed
- Four-step legalizationdocument route
- Mandarin Chinese (Traditional characters)official language
- 18 daysstandard processing
Begin the Taiwan Legalization Process Online
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 18 business days
- We accept credit card payments.
- Track your order history and expenses online.
- State certificate, State Department and TECRO fees are 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$120 / Doc.
DC State Certificate$70 / Doc.
MD State Certificate$50 / Doc.
U.S. Department of State fee$20 / Doc.
TECRO (Taiwan) authentication fee$23 / Doc.
Total:$283 / Doc.
After completion, the finalized document is returned by FedEx.
See expedited options →Why Taiwan Asks for a Legalized FDA Certificate
Because Taiwan cannot join the Apostille Convention, U.S. public documents for use there are authenticated through Taiwan's representative offices rather than by apostille. In Washington, that office is TECRO, which performs the consular functions an embassy would. For an FDA certificate, the chain runs through District of Columbia and Maryland certification, U.S. Department of State authentication and finally TECRO, and we coordinate every step from your uploaded file.
On the regulatory side, one agency covers nearly every product a U.S. health exporter ships to Taiwan. The Taiwan Food and Drug Administration (TFDA), under the Ministry of Health and Welfare, registers medicines and medical devices, oversees cosmetics notification and inspects imported food. Foreign manufacturers work through a Taiwan agent or license holder, and their dossiers typically include proof that the product is approved and sold in the country of origin, which for U.S. goods means an FDA certificate.
Which FDA Certificate Does Your Taiwanese Importer Need?
Match your product to the Taiwanese authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Taiwanese authority | FDA certificate |
|---|---|---|
| Medicines & biologics | Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | TFDA, under the Medical Devices Act | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | TFDA, border inspection of imported food | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & health foods | TFDA, as food or health food depending on claims | Certificate of Free Sale (CFS) |
| Cosmetics | TFDA, under the Cosmetic Hygiene and Safety Act | Certificate for Cosmetics |
TFDA regulates medicines, devices, food and cosmetics, but each product type has its own registration or notification system. Your Taiwan agent or license holder will confirm which FDA certificate the file needs and whether it must be authenticated by TECRO.
How FDA Embassy Legalization for Taiwan Works
Taiwan is not a party to the Hague Apostille Convention, so an apostille is not accepted. Instead, your FDA certificate passes through District of Columbia and Maryland state certification, U.S. Department of State authentication and finally authentication by TECRO, the Taipei Economic and Cultural Representative Office, which acts for Taiwan in the United States.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Taiwan as the destination.
State certification
We obtain the District of Columbia and Maryland state certificates, about 1 business day each.
U.S. Department of State
The State Department authenticates the document in about 9 business days.
TECRO authentication
TECRO authenticates the document in about 7 business days, and we ship it by FedEx to you or your agent in Taipei.
Exporting to Taiwan: What to Prepare
Devices under their own law
Taiwan's Medical Devices Act took effect on 1 May 2021, replacing the older pharmaceutical rules for devices. Class II and III devices need approval in their country of origin before TFDA registration, and a free sale certificate issued within the last two years is part of the file. Device licenses run for five years.
Cosmetics notification and PIF
Under the Cosmetic Hygiene and Safety Act, general cosmetics have needed online product notification since 1 July 2021, and from 1 July 2026 they also need a product information file and GMP compliance. Notifications are valid for three years, so plan for recurring paperwork.
Local agent required
Foreign manufacturers cannot hold Taiwan registrations themselves. A Taiwan agent or license holder files with TFDA and usually holds the product license, so make sure company names on your FDA certificate match the agent's file exactly.
Traditional Chinese documents
TFDA works in Traditional Chinese, and labels must be in Chinese. English-language FDA certificates are commonly used in registration files, but some submissions need a Chinese translation, which should be made after TECRO authentication.
FDA Embassy Legalization Cost for Taiwan
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $120 / doc. | Review, submission, tracking and FedEx dispatch |
| DC State Certificate | $70 / doc. | District of Columbia certification, about 1 business day. Paid by us on your behalf |
| MD State Certificate | $50 / doc. | Maryland certification, about 1 business day. Paid by us on your behalf |
| U.S. Department of State fee | $20 / doc. | State Department authentication, about 9 business days |
| TECRO (Taiwan) authentication fee | $23 / doc. | Taipei Economic and Cultural Representative Office, about 7 business days. Paid by us on your behalf |
| Total | $283/ doc. | Standard processing: 18 business days. Expedited options available. |
FDA Embassy Legalization for Taiwan: FAQs
Can I apostille an FDA certificate for Taiwan?
No. Taiwan is not a party to the Hague Apostille Convention, so FDA certificates are authenticated through state certification, the U.S. Department of State and TECRO, Taiwan's representative office in the United States.
What is TECRO?
The Taipei Economic and Cultural Representative Office represents Taiwan in the United States and handles the document authentication that an embassy would normally perform.
How long does FDA legalization for Taiwan take?
About 18 business days: roughly 1 day each for District of Columbia and Maryland certification, 9 at the State Department and 7 at TECRO, then FedEx delivery.
How much does it cost?
$283per document: our $120 service fee, $70 for the DC state certificate, $50 for the Maryland state certificate, the $20 State Department fee and the $23 TECRO fee.
Who regulates medicines and devices in Taiwan?
The Taiwan Food and Drug Administration (TFDA), under the Ministry of Health and Welfare. It also oversees cosmetics and imported food.
Which FDA certificate does Taiwan need?
Typically a CPP for medicines, a CFG for devices and foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.
FDA Certificates We Legalize for Taiwan
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 Legalized for Taiwan
Upload your FDA certificate today and receive it legalized by FedEx in 18 business days, for $283per document with all state, State Department and TECRO fees included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
18 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
Embassy of Taiwan fee
DC State Certificate
MD State Certificate
Total:
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