Foreign Manufacturer requesting FDA's CFG over their country's FSC

[nwong]

A foreign company (that we work with) is requesting a CFG to facilitate registration of their product in Costa Rica. Apparently, Costa Rica is more responsive to FDA's CFG over their country's FSC. I have informed them that the products listed on the CFG would need to be exported from the US. They have informed me that would not be the case, that this document is only going to be used to speed the registration process and once registered, Costa Rica will not have any issue where the product will be coming from. I can see what appears to be a loop hole here, but I refuse to apply for the CFG knowing the product will not be exported from the US.

Has anyone had any experience with this?


Thanks in advance!

 

[MIREGMGR]

Re: Foreign Manufacturer requesting CFG

Sounds like they want you to help them cheat their system.

The usual rules about cheating would seem to apply.

 

[Ronen E]

A foreign company (that we work with) is requesting a CFG to facilitate registration of their product in Costa Rica. Apparently, Costa Rica is more responsive to FDA's CFG over their country's FSC. I have informed them that the products listed on the CFG would need to be exported from the US. They have informed me that would not be the case, that this document is only going to be used to speed the registration process and once registered, Costa Rica will not have any issue where the product will be coming from. I can see what appears to be a loop hole here, but I refuse to apply for the CFG knowing the product will not be exported from the US.

Has anyone had any experience with this?


Thanks in advance!

Maybe CR doesn't care, but the FDA apparently does.

You could refer to this form, p. 6 s. 2:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052378.pdf

 

[nwong]

Thank you for your reply. I have indeed cited this source and sent this to them. Their rationale is that once it is registered, the target regulating body won't care where it comes from. My comment to the CR was that while the target regulating body might not care, the FDA might.

The confusing part for me is, what if we had already possessed a CFG for these products that we export to other countries? Could this CFG then be used for registration purposes in Costa Rica, even though when originally applied for, Costa Rica was not a Country which the certificate was requested? The countries are not specified on the CFG, and this would only be used to facilitate registration...

I think I already know the answer to this, but some thoughts on the matter would be greatly appreciated.

 

[Ronen E]

Thank you for your reply. I have indeed cited this source and sent this to them. Their rationale is that once it is registered, the target regulating body won't care where it comes from. My comment to the CR was that while the target regulating body might not care, the FDA might.

The confusing part for me is, what if we had already possessed a CFG for these products that we export to other countries? Could this CFG then be used for registration purposes in Costa Rica, even though when originally applied for, Costa Rica was not a Country which the certificate was requested? The countries are not specified on the CFG, and this would only be used to facilitate registration...

I think I already know the answer to this, but some thoughts on the matter would be greatly appreciated.

Medical devices regulations are for those who strive to be in compliance. The question is: Do you?... If not, there are (almost) always ways around (refer PIP).

Every company bending the rules a bit more, eventually makes it a bit harder for the rest.

 

[nwong]

Medical devices regulations are for those who strive to be in compliance. The question is: Do you?... If not, there are (almost) always ways around (refer PIP).

Every company bending the rules a bit more, eventually makes it a bit harder for the rest.

Thank you Ronen. I completely agree with you. I am just arguing the fact with another company's regulatory department and am trying see their point of view. What you and I see as non-compliance, the other sees as a regulatory strategy.
Thanks for your comments Ronen.

 

[Ronen E]

Thank you Ronen. I completely agree with you. I am just arguing the fact with another company's regulatory department and am trying see their point of view. What you and I see as non-compliance, the other sees as a regulatory strategy.
Thanks for your comments Ronen.

Calling it "a regulatory strategy" legitimises such line of thinking.

Well -

I wouldn't name short-term gains at the expense of long-term / broader mal-effects "a strategy" at all. At best, it's bad tactics.

Sorry.

 

[SQ2012]

We have had a similar request from another regulatory authority, in this case the manufacturer is not in located in the US while the product is FDA approved.
My Question is can US FDA issue the CFG to a non resident company?

 

[Michael Malis]

We have had a similar request from another regulatory authority, in this case the manufacturer is not in located in the US while the product is FDA approved.
My Question is can US FDA issue the CFG to a non resident company?

In short - No, and it is illegal!

 

[Ronen E]

We have had a similar request from another regulatory authority, in this case the manufacturer is not in located in the US while the product is FDA approved.
My Question is can US FDA issue the CFG to a non resident company?

As far as I understand, a CFG can be issued (subject to other conditions - look at the form I referred to above) as long as the devices are being exported from the USA (even if they are imported into the USA first).