Eligible to obtain certificate of foreign government (CFG)

M

Mike_Benz

#1
Hello all,

We recently have been asked to obtain CFG to register our medical devices in a new market. We want to make sure we are fully compliant with USFDA guidelines as well as go about this as economically as possible in case we enter similar markets in the future.

My questions:
1 - If our products have USFDA approval, but made in another country, how can we obtain CFG as our products are not "exported from the USA?'
note: we had initially planned to first import the products into the States and then export the same products outside of the States. However, this carries what could be a large unnecessary cost.

2. If we pursue the import-export strategy, instead of importing all of the goods could we import a single carton of the complete variety of products (listed on the CFG) and still be 100% USFDA compliant? This seems like it would be acceptable and within USFDA guidelines and would surely cut our costs and make business in these markets more attractive.

3. Do you have any advise as to the best regulatory strategy in this case? Something I may note have thought of. If so, can you tell me as well as provide me with an official resource that verifies this?

4. Last question. Considering we are the legal manufacturer in the eyes of the USFDA, and our US-company based overseas is where the goods are exported from, does this satisfy US FDA in and of itself (as "export from the USA" could mean export by a US company which pays taxes in the USA). The only reason I could imaging the USFDA requiring manufacturers to export from the USA is for for tax dollars. Why else would they? FDA approved should be FDA approved, no matter where it is exported from. Unless I'm missing something! What do you think?

Thank you all so much in advance :)
 
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M

Mike_Benz

#3
Please bump! I'm sure this would be very educational to the community.

thanks!

any thoughts on 1 or more of the points above?
 
L

Laura Halper

#6
If I understand the question correctly, the devices in question are made in a U.S. facility based on foreign soil, and the devices made in that plant are NOT sold in the U.S. and the foreign-based facility is NOT registered with FDA.

In that case, a CFG is not appropriate because FDA will not/cannot state that the devices made at the foreign-based facility are in compliance with GMP (21CFR 820) requirements.

If the foreign-based facility has ISO 13485 certification, you may be able to satisfy the regulatory authorities by submitting that certification along with evidence of 510(k) clearance or PMA approval.

If the foreign-based facility is registered with FDA, then I would go ahead and request the CFG even if devices from that facility are not sold in the U.S. FDA may issue the CFG if the facility is registered.

Mike, you did not mention which country is asking for the CFG. In my experience, sometimes countries with less sophisticated regulatory schemes just ask for CFG because it is an easy requirement to impose. But if you can't get CFG you can sometimes "push back" and explain why CFG is not applicable in your case and offer an alternative such as ISO 13485. In one case the regulatory authority accepted a letter on company letterhead and signed by company official, attesting that the facility and the devices made in the facility complied with GMP's.
 
M

Mike_Benz

#7
Hello Laura,

Thank you so much for responding to my post!

The company I work for is registered with the USFDA and we have listed all 510k products under our entity listing within the USFDA.

We are a specification developer and repackager/ relabeler and thus the legal manufacturer of our goods recognized by the USFDA.

The products are made on foreign soil through our subsidiary who is manufacturer of record.

At present, while the goods are marketed in the US and are "saleable" in the US, we have yet to import them as our concentration is on foreign markets. At the moment, we merely hope to acquire CFG for our USFDA approved (510k) products to facilitate registration in a variety of markets that prefer US CFG over country of origin free sale certificate.

"If the foreign-based facility is registered with FDA, then I would go ahead and request the CFG even if devices from that facility are not sold in the U.S. FDA may issue the CFG if the facility is registered."

We are about to obtain CFG for the approved items, and are confident that we will receive it, but are a little concerned with the statement on the USFDA website "All devices must be exported from the US." We want to make sure that we are in full compliance.

Laura, do you have an authoritative website that would indicate that what we are doing is acceptable buy the USFDA?

Please help.

Thank you :) :)

Mike
 
L

Laura Halper

#8
Mike,
I have not encountered a situation exactly like yours before, and don't see similar situation discussed on the FDA website. I suggest you contact FDA to find out if they can/will issue CFG under these circumstances even though you are not exporting from U.S. soil. Here's FDA contact information from their website:

Telephone number: 301-796-7400
Email: [email protected]

Regards,
Laura
 
M

Mike_Benz

#9
Thank you Laura.

We have contacted them on several occasions and unfortunately they are of little help when it comes to defining "all devices must be exported from the USA". Do you have any idea why (the actual purpose) that this requirement exists? If I knew the reasoning then that may help our approach in the future.

Thank you again!
 
M

MIREGMGR

#10
Do you have any idea why (the actual purpose) that this requirement exists?
Because of the wording of the law under which FDA is authorized. FDA has no authority over a device-family that is not either made in, marketed in or transited through USA. Thus they cannot certify it.
 
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