Home / US FDA Registration in India

What is Food & Drug administration (FDA)?

FDA stands for food & drug administration. FDA is a government agency of United States responsible for the safety of food, dietary supplements, vaccines, human drugs, medical devices, cosmetics, blood products and other biologicals, radiation-emitting electronics, tobacco products and veterinarian products being manufactured or sold in the United States. Organizations involved in the business of manufacturing, repacking or relabeling of products in the above mentioned industries has to mandatorily register with FDA to export their products legally to foreign countries. There is an exception in the case of cosmetics where registration is voluntary.

FDA certificate is issued by food and drug administration department of US to the firms or organization exporting products from United States to foreign countries or foreign customers. Foreign government or foreign customers often ask US firms or organizations to supply a certificate so that foreign government knows the regulatory and marketing status of the product. FDA also enforces rules & regulations for different industries as well as having involvement in inspection process too.

The FDA registration process varies from industry to industry but generally annual registration has been done in which organization need to list all the drugs manufactured, prepared, propagated, compounded or processed for commercial use in US. The results of inspection led by FDA for FDA registered organizations are available on FDA website.

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Types of Export Certificates issued by FDA

FDA issues various types of export certificates and they are as follows –

Certificate to a foreign government

A certificate to a foreign government is a certificate by FDA to US firms or organizations in order to export food categories such as human drugs & biologicals, animal drugs and devices that are legally marketed in the US. The certificate ensures that the particular product is marketed and legally exported from US and fulfills all the requirements of FD&C act. The certificates issued in this case are CBER, CDRH & CVM.

Certificate of Exportability

A certificate of exportability is the certificate issued by FDA to US firms or organizations for the export of human drugs & biologicals, animal drugs and devices that cannot be legally marketed in the US but fulfills the requirement of section 801(e) or 802 of FD&C act and may be legally exported. The certificates issued in this case are CBER, CDRH & CVM.

Certificate of free sale (Certificate of Export for Seafood)

The certificate of free sale is provided for export of medical foods, dietary supplements and use of cosmetics products that are legally marketed in US. No fee is chargeable for such certificates. The certificate issued in this case is CFSAN.

Certificate of Cosmetics

Certificate of cosmetics is provided for export of cosmetic products. It is not mandatory to register under FDA in case of cosmetic products. In order to take this certificate, you must comply with the requirements mentioned under section 801(i) of the FD&C act (21 U.S.C 321 (i)). These certificates are not issued for product marketed with drug claims such as treatment claim, cleansers with acne.

Health certificates

Some health certificates are also issued by FDA for collagen and gelatin products planned for export to EU countries and specific risk material certificates for collagen and gelatin products planned for export to Non-EU countries. There is no fee chargeable for such certificates.

Whether FDA issues export certificate for unapproved products?

In the year 1996, there is an amendment in the FDA act to issue certificates for certain products which are not allowed to be market in US. It includes certificate of exportability for animal drugs, biologicals and devices that are exported under this act but not marketed, sold or distributed in United States. In case of products related to human drugs, FDA issues a certificate of pharmaceutical product which contains special note or document which clearly says that it is an unapproved product. They did not issue certificates of exportability for dietary supplements, food & cosmetics.

When does FDA refuse to issue an Export Certificate?

FDA refuses to issue certificate in the following circumstances –

  • If it is not fulfilling the requirements of the act
  • If manufacturing facility is not registered or listed with FDA
  • If manufacturing facility fails to comply with cGMP regulations
  • If the product is not exported from US

Note: FDA will not issue certificate of free sale & health certificates, if product is under FDA regulatory action. FDA will not issue certificate of exportability, if product fails to comply with cGMP regulations.

How Finacbooks helps in US FDA Registration in India?

Finacbooks is a leading Indian platform with more than 10 years of experience in helping organizations and providing them FDA certificate. We will guide you through the entire process to get FDA Certificate. To avail the best deals on US FDA Registration in India, kindly call us at 8800221252 or you can also e-mail us at info@finacbooks.com


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