Strategic Procurement Services

Strategic Procurement Services

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Exporting Non-Infectious Human Material to the USA

REQUIRED INFORMATION FOR ALL SHIPMENTS OF NON-INFECTIOUS HUMAN MATERIAL

The United States Centers for Disease Control and Prevention (CDC) regulates the importation of human material which includes both infectious and non-infectious substances. 

Non-infectious substances do not require import permits; however, since the regulation of these products was moved from the U.S. Food and Drug Administration (FDA) to the CDC, additional documentation is required. 

For shipments of non-infectious materials of human origin, the following information must always be provided on the customs documentation regardless of the value of the goods.

  • Human origin
  • Non-infectious
  • Description of the material - blood, serum, plasma, etc.
  • Source of the material - bone, tissue, organ, hair, etc.
  • End use - diagnostic, transplant, etc.

Example of a good description - 'Human, non-infectious blood sample for diagnostic purposes'.

In addition, a signed statement attesting to the non-infectious nature of the material must be provided separately. The statement must be signed by the importer or the person responsible for the shipment.

This signed certification must contain the complete description of the material and how it is deemed non-infectious - either by rendering non-infectious, or not known or suspected to contain infectious material.

Download the Queen's Non-Infectious Material of Human Origin Statement template.

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