Import-Export of Medical Device components into the US

P

pourshams

We import some medical device components for further process in US which will be a surgical camera at the end and then export it out of the country (we don’t market in usa at all). Per my conversation with FDA we still need to register with them as exporter.

How about importing the parts? one section of FDA website says we need to provide them with information on initial import. Does anybody know what information should we provide and how?

And what bond this para is talking about:
“The information includes a statement that confirms the intent to further process such article or incorporate such article into a product to be exported and identifies entities in the chain of possession of the imported article. At the time of initial importation and before delivery to the importer, initial owner, or consignee, a bond must be executed providing for liquidated damages in the event of default, in accordance with Bureau of Customs and Border Protection (formerly called U.S. Customs) requirements.”

THANKS FOR YOU GUY'S HELP
 
M

MIREGMGR

We import some medical device components for further process in US which will be a surgical camera at the end and then export it out of the country (we don?t market in usa at all). Per my conversation with FDA we still need to register with them as exporter.

If you are a medical device manufacturer and are located within USA, yes, you must Register.

How about importing the parts? one section of FDA website says we need to provide them with information on initial import. Does anybody know what information should we provide and how?

If what you import are Components as defined in 21CFR 801.65(a), your import of them is not regulated by FDA. If what you import qualifies as a medical device, then yes, you must be additionally registered as an Initial Importer.

And what bond this para is talking about:
?The information includes a statement that confirms the intent to further process such article or incorporate such article into a product to be exported and identifies entities in the chain of possession of the imported article. At the time of initial importation and before delivery to the importer, initial owner, or consignee, a bond must be executed providing for liquidated damages in the event of default, in accordance with Bureau of Customs and Border Protection (formerly called U.S. Customs) requirements.?

I'm not aware of the specific location within the regulations where that appears, but in general it refers to the excusing of imported goods from tariffs etc. if they are to be 100% exported after further processing. You post a bond to assure that the goods in fact are subsequently exported.
 
P

pourshams

Thanks for detailed response.
One question. When we export this, i know we shoudl be registered with FDA as "manufacturer of export only" but do i still need to get the "certification for export from FDA" or i only need it if the country we are shipping to needs it?
by the way i wanted to check 21CFR 801.65(a) but it seems section 801 is labeling requirement and does not have 801.65. Am I doing sth wrong?

Thanks
 
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M

MIREGMGR

do i still need to get the "certification for export from FDA" or i only need it if the country we are shipping to needs it?

Export certificates are the not-quite-equivalent of the Certificate to Foreign Government that US device makers obtain to prove to foreign regulators that their goods are legal for sale in USA. Thus you only obtain such a certificate if your customer-country needs it.
 
P

pourshams

Thanks
I looked up 21CFR 801.65(a) but it seems section 801 is labeling requirement and does not have 801.65. Am I doing sth wrong?
 
P

pourshams

Thanks, i looked it up. It more explains type of establishment rather than components exempt from it.
para "a" says "A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part."
so if the final device needs to be registered we still have to register as first importer for every single componenet we receive?


by the way when it is calling out for example section 210 of this ACT or refers to 510(G) where can i get those sections? i searched their website.

Thank you for helpin me on this
 
M

MIREGMGR

It more explains type of establishment rather than components exempt from it.
para "a" says "A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part."
so if the final device needs to be registered we still have to register as first importer for every single componenet we receive?

If I understand your explanation correctly, I disagree with your interpretation. 21CFR 807.65(a) bears on how Component is defined, and therefore on whether the maker of a component must register. If the maker of a component is not required to register as a Manufacturer, the importer of that component is not required to register as an Importer. Only importers of Medical Devices must register as Initial Importers.

by the way when it is calling out for example section 210 of this ACT or refers to 510(G) where can i get those sections?

Sometimes interpretation is necessary, because numbering in the Act isn't the same as numbering in regulations. In general, you can find citations by searching on 21CFR plus the section number you have. Google, for instance, typically will show leads to both Act and regulation entries, if the search term might be either.

For instance, 21CFR 210 is at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=210.
 
P

pourshams

Thanks,
one of the components that we are importing is a monitor which is built by our vendor, we will re-label it before testing and shipping to our customer (along with the control unit and camera and ---) which is outside USA.
Does that monitor qualify as medical device you think? or since it needs further processing which in this case is labeling and testing it would not?
 

Ronen E

Problem Solver
Moderator
Thanks,
one of the components that we are importing is a monitor which is built by our vendor, we will re-label it before testing and shipping to our customer (along with the control unit and camera and ---) which is outside USA.
Does that monitor qualify as medical device you think? or since it needs further processing which in this case is labeling and testing it would not?

If the original labelling indicates a medical use then it may well be considered a Medical Device. However, if your company is the first to assign it a medical intended use (via relabeling) then it only becomes a medical device when you release it.
 
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