CFG - Certificate for Foreign Government - Medical Device Company based in CA, USA

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mukesh sabarad

We are a medical device company based in CA, USA. Besides manufacturing our own devices we also have some OEM products for companies in the USA. The question I have is do we need to put the OEM products on the CFG or should this be on the CFG of the company for whom we make the OEM products?

Any help/advice in this matter will be appreciated.
 
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SteelMaiden

Super Moderator
Trusted Information Resource
Re: Cfg

Granted, FDA is not my area of expertise, but could you help this oldster out and spell out what CFG stands for? (I would have guessed a configuration file, but that doesn't fit well with FDA :))

Thanks!
 
M

mukesh sabarad

Re: Cfg

Granted, FDA is not my area of expertise, but could you help this oldster out and spell out what CFG stands for? (I would have guessed a configuration file, but that doesn't fit well with FDA :))

Thanks!

CFG - Certificate for Foreign Government
 
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MIREGMGR

Re: CFG - Certificate for Foreign Government - Medical Device Company based in CA, US

We are a medical device company based in CA, USA. Besides manufacturing our own devices we also have some OEM products for companies in the USA. The question I have is do we need to put the OEM products on the CFG or should this be on the CFG of the company for whom we make the OEM products?

Are the "OEM products" contract manufactured, and/or precursor devices for incorporation into a more-inclusive device or kit?

If yes, are they sold only to US companies?

A Certificate to Foreign Government from you has no meaning to a US company, since the products do not pass through another country's Customs. A CTFG is relevant only to an export/import relationship. Based on the information provided above, there is no reason for your OEM products to be listed on a CTFG from your company.

I also don't understand the latter comment in the second sentence above. If you sell a product to Company X, and Company X incorporates that product into a medical device of their own, (most of) the regulatory responsibility for whatever you sold them has passed to them. Their CTFG, to be made available to their export customers, will list their medical-device products. The fact that they bought a component of their product from you is irrelevant to the content of their CTFG.
 
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