Need to use official FDA documents in China or overseas?
FDA Certificates to Foreign Government, Certificates of Pharmaceutical Product, Certificates of Exportability, and other qualifying official FDA / HHS documents are considered U.S. federal documents. For use in Hague Convention member countries, first verify if the document meets the criteria for a federal Apostille, then follow the U.S. Department of State's Federal Apostille process.
Official FDA documents are not California Secretary of State documents
The U.S. Food and Drug Administration is part of the U.S. federal government system, and its official export attestations and related certificates are classified as federal documents.
The U.S. Department of State explicitly lists Certificates to Foreign Government, Certificates of Pharmaceutical Product, and export-related certificates issued by HHS as examples of documents eligible for federal authentication.
Therefore, qualifying official FDA / HHS documents must be processed through the U.S. Department of State · Office of Authentications via the Federal Apostille route, rather than the California Secretary of State.
Common FDA export certificates
There is more than one type of "FDA document." Different product categories, FDA Centers, and export purposes may correspond to different certificates.
Often used to certify that products can be legally sold in the U.S. and to support product exports to other countries.
Common for drugs, biological products, or related regulatory affairs, used for overseas pharmaceutical regulation or registration procedures.
Depending on the specific product and regulatory circumstances, the FDA may provide a corresponding Certificate of Exportability.
If you have a different type of certificate, please provide the full document. We will confirm the authentication path based on the issuing authority and signature style.
Where might these be used in cross-border transactions?
Official FDA export certificates are primarily for product export, overseas registration, and regulatory affairs; they are fundamentally different from standard personal Apostille documents.
Overseas Product Registration
Foreign regulatory agencies may require official FDA documents for product registration, filing, or market access.
Medical Device & Pharmaceutical Exports
Medical devices, pharmaceuticals, biologicals, or other FDA-regulated products may use corresponding certificates during export.
Verification by Foreign Regulators
Foreign government agencies may require proof that the documents were indeed officially issued by the U.S. FDA / HHS.
The correct Apostille path for official FDA documents
Genuine official FDA / HHS documents are federal documents. If the document meets Department of State requirements, it must follow the federal document authentication route directly.
Whether a client's company is in California does not turn an FDA Federal Document into a California state document. The level of authentication is determined by the issuing authority, not by the state where the applicant is located.
What document elements does a Federal Apostille check?
The U.S. Department of State currently requires federal documents to be originals or certified copies, bearing identifiable official signatures and agency information.
Original / Certified Copy
The document must be a compliant original or a certified copy, not a standard photocopy.
Federal Official Signature
The signing official's signature, printed name, and title must be identifiable.
Agency Seal · Date · Letterhead
The document must also include the appropriate federal agency seal, issue date, and agency letterhead.
Processing Steps
The most important part of FDA documentation is confirming that it is a formal FDA / HHS federal document and that the version meets current Federal Apostille requirements.
Place your order online
Complete the order on this page, and inform us of the country where the document will be used.
Verify FDA document
We confirm the document type, FDA / HHS issuance details, official signature, seal, and document version.
Process Federal Apostille
Once the document meets requirements, we proceed via the U.S. Department of State's federal authentication path.
Delivery
After the Apostille is complete, we will send or deliver the originals as specified in your order.
What do you need to prepare?
Provide the Certificate to Foreign Government, CPP, Certificate of Exportability, or other official FDA documents requiring authentication.
Please include the agency letterhead, issue date, official signature, printed name, title, and agency seal.
Tell us the destination country for the document. If it is for China, just let us know.
Do not notarize official FDA originals
For qualifying federal documents, the U.S. Department of State explicitly requires: Do not add a standard notary acknowledgement to the original federal document in order to obtain a Federal Apostille.
What requires authentication are the signatures and seals of the FDA / HHS federal officials and the agency itself, not the signature of a California Notary.
Therefore, if old pages suggest "Notary visit → California Secretary of State" as the standard path for official FDA documents, they should be deleted entirely.
Company FDA-related documents are not official FDA documents
A document containing terms like "FDA Registration," "510(k)," or "FDA compliant" does not mean it is an FDA Federal Document.
If the document is actually a company-generated statement, Distributor Letter, Manufacturer Statement, or internal compliance document, it is still considered a private business document and should be analyzed under private document signing, notarization, and state-level Apostille paths.
Thus, the first step on this page is always identifying who issued the document , not just looking for the letters "FDA" on the page.
What is a Certificate to Foreign Government?
According to the FDA, the Certificate to Foreign Government is commonly used to export products that can be legally sold in the U.S.
For example, foreign regulators may require this certificate during the registration or import of certain medical devices, biological products, or other FDA-regulated products.
However, different FDA Centers have different application methods and certificate types available. If you do not have an FDA certificate yet, you should first obtain the official document through the appropriate FDA export certification system or procedure; the Apostille is a subsequent step.
An Apostille does not re-certify a product as "FDA Approved"
The purpose of a Federal Apostille is to certify the signature, identity, and agency seal of the relevant federal official.
It does not re-examine the product, factory, 510(k), PMA, registration, listing, or other FDA regulatory status.
The regulatory facts expressed in the FDA document itself should be taken as they are; the Apostille only handles the cross-border authentication of that federal document.
What if Chinese institutions require a translation?
Official FDA documents are usually issued in English. Whether a Chinese translation is required depends on the requirements of the final receiving institution.
If a translation is needed, you can prepare a complete Chinese translation with a translator's certification, and confirm based on actual usage whether notarization of the translation is required.
The original FDA Federal Document and the translated document are two different levels of documentation; you should not replace the correct Federal Apostille by adding a standard notary to the FDA original.
Why choose Landz?
Confirming official FDA status first
We distinguish between FDA / HHS Federal Documents and business documents made by companies, ensuring you don't start with the wrong level of authentication.
Do not send federal documents to the Secretary of State
Eligible official FDA documents are processed via the Federal Apostille route and are not mechanically subjected to a California Apostille.
From document inspection to final delivery
We first verify the certificate type and document version; once eligibility is confirmed, we proceed with federal authentication and finally deliver the original document with the Apostille completed.
Frequently Asked Questions
Why is an FDA document not a California Apostille?
Because the FDA is a U.S. federal agency. Official documents genuinely issued by FDA/HHS federal officials should be processed according to the authentication hierarchy for federal documents.
Who provides the Apostille for official FDA documents?
For eligible FDA/HHS federal documents, the Apostille is issued by the U.S. Department of State's Office of Authentications following the federal document pathway.
What is a Certificate to Foreign Government?
It is a type of export certificate provided by the FDA, commonly used to support the export of products legally marketed in the U.S. and for related regulatory affairs in other countries.
What is a CPP?
CPP stands for Certificate of Pharmaceutical Product, commonly used for pharmaceuticals, biological products, or related overseas regulatory affairs.
What is a Certificate of Exportability?
It is another type of export-related certificate that the FDA can provide. Whether it is applicable to your product depends on the product type and its FDA regulatory status.
Can an FDA Registration Certificate be processed with this service?
We must first check who issued the document. Some so-called "FDA Registration Certificates" on the market are actually created by companies or third parties themselves and are not federal documents issued by the FDA. Such documents cannot be treated as official FDA certificates based solely on their title.
Does having an FDA logo mean it is an official FDA document?
No. The key factors for assessment are the issuing authority, official signature, official's name and title, agency seal, issue date, and letterhead; you cannot rely solely on the logo.
Do official FDA documents need to be notarized by a Notary Public first?
For eligible original federal documents, a standard Notary Public notarization should not be added in order to obtain a Federal Apostille.
Can regular photocopies be processed?
A Federal Apostille should be issued for an original or certified copy that meets the requirements. A regular photocopy cannot automatically substitute for a valid federal document.
Can electronic FDA documents be Apostilled directly?
We must first check the specific document version. The U.S. Department of State has corresponding requirements for federal documents regarding official signatures, printed names, titles, agency seals, issue dates, and letterheads; one cannot determine eligibility solely because a document originates from an online system.
Does the Apostille prove that a product has been FDA-approved?
No. The Apostille only certifies the signature, identity, and agency seal of the federal official on the document and does not re-examine the FDA regulatory status of the product.
Is a Chinese translation needed?
This depends on the requirements of the final receiving agency. If Chinese regulatory authorities or other entities require a Chinese version, you can prepare a professional translation separately.
Is consular authentication still required for use in China?
For U.S. documents subject to the Apostille Convention, once the corresponding U.S. Apostille is completed, the traditional Chinese consular authentication process is typically no longer required.
Can I send a PDF to you first for review?
Yes. We recommend providing the complete FDA document, retaining the agency letterhead, issue date, official signature, printed name, title, seal, and other information, to facilitate confirmation of whether the current version is suitable for a Federal Apostille.
What happens after placing an order?
After an order is placed, we will first verify the FDA document type, issuing authority, document version, and the destination country. If it is a qualified FDA/HHS federal document, we will then process it via the U.S. Department of State's Federal Apostille pathway.
Send us your FDA document first to confirm if it is a federal document
After completing your order, we will first check the issuing authority, official signature, and document version of the Certificate to Foreign Government, CPP, Certificate of Exportability, or other FDA documents. Once we confirm that it is a qualified federal document, we will proceed via the U.S. Department of State Federal Apostille path.
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