If you’re hoping to export a medical device to the USA, don’t assume that your product will be exempt from regulation because it’s already approved in your country. This is simply not true. You will have to meet FDA regulations if you hope to reach the market in the US.
If you’re a foreign manufacturer looking to export to the US, you’ll be subject to several regulations. You’ll need to register and ensure manufacturing is undertaken in line with US quality regulations.
Your site may be subject to US inspection to ensure you comply. You’ll also need to appoint a US agent, who will coordinate communication between your company and the FDA and arrange and facilitate the inspection process. Finally, you may need to seek 510k approval, and this can be complex. Many manufacturers prefer to use third-party companies to help with FDA 510k.
If you’re asking yourself, “what companies can help with FDA 510k issues?”, the answer is those that are accredited by the FDA as part of the Third-Party Review Program.
If you manufacture a product that emits radiation, you’ll be subject to regulations under the Federal Food, Drug, and Cosmetic Act, Subchapter C – Electronic Product Radiation Control.
The export process
First, you’ll be required to meet the requirements of the Bureau of Customs and Border Protection (CBP), who have a range of responsibilities including all taxes, fees and duties on imported goods. You will need to file all necessary paperwork relating to the import of your product with the local CBP office. You’ll need to provide the device name and product code; providing the correct information will help expedite the process. You can ask a third-party customhouse broker to file the relevant information on Operational and Administrative Systems for Import Support (OASIS) on your behalf. You can find out more about the regulations relating to import procedures on the FDA website.
A copy of this entry will go to the FDA, who will determine if your product complies with their requirements. If your device does not comply, you’ll be issued a “Notice of FDA Action” and you must supply relevant evidence or risk the entire shipment being destroyed. A notice may also be issued if the FDA requires reassurance on the efficiency and safety of the device.