Attaining FDA Export Certificates For Regulated Products: Practical Insights

The products that are exported from the United States are issued a certificate from the Food and Drug Association (FDA). This certificate provides information over the regulatory and marketing status of the product, so it is considered one of the utmost required documents when exporting products for such firms.

Why is an export certificate from FDA important?

An export certificate from FDA helps custom officials in the importing country with details on the product meeting US regulations and being fit to be imported into the country.

On request, FDA issues certificates to ease out the process of export of products that meet the guidelines and can be legally marketed into the US or may be legally exported out of the US, if not marketed.

Certificates issued by FDA:

There are 7 types of FDA export certificates:

  • Certificate of Free sale for food, food supplements and cosmetics
  • Health Certificates for Food/Feed
  • Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate for raw material
  • Certificate of a Pharmaceutical Product for licensing the product for sale in importing country
  • Non-clinical Research Use Only Certificate for products marketed in and exported from the US
  • Certificate to Foreign Government for export of human and animal drugs and devices that can be legally marketed in the United States
  • Certificate of Exportability for export of human and animal drugs and devices that cannot be legally marketed in the United States

There are products that can be legally marketed in the US and some that cannot be legally marketed but can be exported from the US. For organizations involved in the export of FDA regulated products from the US, it is imperative to keep abreast of the documentation and paperwork required so as to avoid the delays in custom clearance and attaining the FDA export certificate.

Attend a LIVE audio conference with quality and regulatory expert speaker, Dr. Mukesh Kumar to get hands on advice into the process and paperwork required for getting export certificates from FDA. Attending this session will give you insights into the certificate issuance process, regulatory requirements and dealing with denials. In this audio conference, you’ll gain from the practical instructions that’ll help you in the process of getting export certificates from U.S. FDA. This conference will run you through descriptions of key requisites, perceptions, and frequent issues that exporters of FDA-monitored products are likely to come across.

If you are an exporter or importer of a FDA-regulated product, a compliance officer, regulatory/legislative affairs professional or a supply chain manager, you stand to gain from this conference towards handling export of FDA related products in a better way.

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