E Apostille for Certificate of Non-Clinical Research Use Only Materials (NCR)

The "Non-Clinical Research Use Only" certificate is for product(s), material(s), or component(s) that are not used to prevent, treat, or diagnose human disease. The manufacturing facility is required to label these products according to 21 CFR 809.10(c)(2)(i) or 21 CFR 312.160, as appropriate.

step 1:

Upload your document in PDF format.

step 2:

Fill order form and verify the authenticity of your document.

step 3:

Decide method of shipping.

step 4:

Pay a total fee of $57

Further on, The NCR Certificate is for the export of a non-clinical research use only product, material, or component that is not intended for human use which may be marketed in, and legally exported from the United States under the Federal Food, Drug, and Cosmetic Act (FD&C).

Among the requirements to be met prior to the issuance of this certificate are the following:

The "Non-Clinical Research Use Only" certificate is for product(s), material(s), or component(s) that are not used to prevent, treat, or diagnose human disease.

The manufacturing facility is required to label these products according to 21 CFR 809.10(c)(2)(i) or 21 CFR 312.160, as appropriate.

All products listed on NCR Certificate must be exported from the U.S.

Certificate Of Non-Clinical Research E Apostille

Each NCR Certificate request must be requested by the U.S. manufacturer. Requests received from a foreign firm will not be considered. A U.S. firm must appear on each NCR Certificate.

All contract manufacturers and contract sterilizers involved in the manufacturing process must be identified on the 3613c form, regardless of whether or not they will appear on the certificate.

CDRH (An FDA office) processes requests for certificates or permits and submissions of simple notifications for the exportation of medical devices, including radiation emitting electronic products. The CDRH Export Certification Application and Tracking System (CECATS) is used to process these requests and submissions.

CECATS (an FDA system) is a web-based application system for requesting export documents. This system offers several benefits, including a reduction in certificate processing time, real-time validation of firm specific data, and status updates of the request. Using CECATS, users can make changes to an export application prior to review, upload additional documents such as mailing labels, and clone (auto populate) previously submitted application information for future export requests using the “clone” icon.

To submit a request using CECATS:

Sign into your CECATS account using your account ID and password. CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS) using the establishment’s FURLS account ID and password. See Accessing CECATS and Creating a Subaccount for additional instructions on how to access the system or set up a subaccount.

Upon responding Yes to the question "Will the devices be exported from the United States?," you will be directed to the CECATS Home screen.

Afterwards, you can choose the application needed.

For more legal information about the NCR certificate, please refer to the general guidelines set by FDA.

In order for you to use our E- Apostille service for your NCR certificate, you can do that by uploading your document in PDF format to our website and fill up our order form, and specify which type of mail/courier we should use to send you back the Apostilled document. This way you will save a one-way postal (or courier) service cost, and time. Generally speaking, our fees for this type of service is a fixed $62.0.