Hello Everyone,
I currently work overseas and am interested if anyone here has any experience with importing finished product to the USA for export? Specifically I am interested in capital equipment, where foreign specifications, e.g. plug type, voltage requirements, language requirements, are different than those for product manufactured for use in the USA.
(The capital equipment is cleared in the USA, and that the testing provided to support clearance covered regional variants, e.g. electrical testing was done on all available voltage models.)
So far I have been able to find the following references:
In addition, my colleague requested advice via DSMICA, however the response that we received was a copy/paste of information from the links above; we were not able to obtain any additional clarification.
The following are excerpts from the Importing into the U.S. website:
Medical Devices
Foreign manufacturers
Foreign manufacturers must meet applicable United States (U..S.) medical device regulations in order to import devices into the U.S. even if the product is authorized for marketing in another country. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval, if applicable. In addition, the foreign manufacturers must designate a United States agent. As with domestic manufacturers, foreign manufacturing sites are subject to FDA inspection. Information on U.S. regulatory requirements can be found in the Device Advice section.
Import for Export
A firm may not import a finished unapproved device without prior marketing clearance, even if the device is to be imported solely for subsequent export. The terms "further processing" and "incorporation" as detailed in the Regulatory Procedures Manual is rather broad in its interpretation. For example, a device imported for further packaging or labeling would fall into this category; a device which is simply stored without any further action prior to export would not fall into this category.
Assuming that the capital equipment is cleared in the USA, and that the testing provided to support clearance covered regional variants, e.g. electrical testing was done on all available voltage models, what other considerations are people taking into account for import for export?
- Do you have to supply a statement of intent to export with each shipment to the US customer (i.e. the exporter)? Alternatively, are you labeling every device as "export only"?
- If the product is being sold to distributors (i.e. external customers) who then manage the supply chain to the final customer (outside of the USA) - what level of visibility of the supply chain do you have once the product leaves control of the manufacturer/importer?
- With respect to labeling - (again keeping in mind that the product is cleared in the USA) - should US-specific labeling requirements, e.g. Rx only, conformance marks, still be included in the labeling? Or could this be considered to be a risk, e.g. could US-specific labeling imply that the product can be used in the USA?
Any advice or sharing of others' experiences would be greatly appreciated!
Thank you!
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Elizabeth Goldstein RAC
Auckland
New Zealand
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