Export of Laser Products to the USA (CDRH)

To export a laser system or laser product to the United States in compliance with applicable regulations, FDA registration is required. In the U.S., the marketing and import of laser products are subject to mandatory legal requirements.

The relevant provisions are set out in 21 CFR 1040.10 and 1040.11. Unlike certain technical standards that may be applied on a voluntary basis, these regulations are legally binding. CFR stands for Code of Federal Regulations.

We can manage the CDRH registration process for you online. This includes preparation of the Laser Product Reportand submission of the required documentation to the U.S. authority for review. The application generally includes your English operating instructions as well as confirmation from your designated U.S. agent.

Once the application has been accepted and an accession number has been assigned, we will forward it to you without delay. Your product can then be exported to the United States using the relevant customs documentation, in which the accession number must be stated.

Please note: If no accession number is available, or if the submitted documents are incomplete or incorrect, U.S. customs authorities may detain or seize the goods.