I am looking to fully understand the regulations surrounding the export of used medical equipment to the USA. Do we as the exporter need to seek FDA approval or is this the responsibility of the importer?
Many thanks in advance
You will probably need to get the goods inspected by SGS beforehand, other than that you will need to raise a Commercial Invoice, Packing List. I will ask my USA Agents what they require when goods require and what is the Consignees responsibility.
If you can leave me your contact details I will ring or email you soon as I have an answer later today. Also can you given me an idea of what the medical equipment consists of as well.
My details are as below.
Business Development Manager
STI Global Logistics Ltd
Unit 1 Lords Court
Basildon Essex SS13 1SS
Tel: +44 (0)1268 289653
Mobile: +44 (0)7554 117585
Fax: +44 (0)1268 289649
Well when exporting medical devices, the companies should first look out whether their devices have been approved or cleared by the FDA or not. Medical devices, which are officially promoted in the U.S., can be exported in any country without earlier FDA approval, whilst the devices which are not promoted legally in U.S. should have to take initial approval.
The medical equipments like you can see on http://www.ilexmedical.com/ etc. must pass the criteria such as safety, security, designs etc. of regulatory bodies to get approval for supplying in the market.
However, if you want more detailed information about exporting medical device, you can read the helpful article on http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050521.htm. I hope it will clarify your entire doubt.