Updating Certificate of Foreign Government (CFG's)

M

markvm68

#1
I work for a company that has close ot 20,000 different catalog numbers that we list on our Certificate of Foreign Government (CFG). In the next year we are going to be coming out with multiple new products that we will need to add to our CFG. As part of our registration process, we have about 40 countries/customers that require us to send a new CFG everytime it changes. With the current launch schedule we will need to get a new CFG every three to six months.

Does anybody know of any ways around this?

Any input is appreciated.
 
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M

MIREGMGR

#2
Re: Updateing Certificate of Foreign Government (CFG's)

As of the publication of the current guidance (http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm) earlier this year, the contact for medical device inquiries was Leila Lawrence at 240-276-0132. I'd think she'd be a good starting point for what seems to me to be a valid guidance question.

Alternately, you could ask DSMICA. I'd think that they'd bounce you back to CDRH, though, since it's pretty obviously a boundary question.
 
M

markvm68

#3
Re: Updateing Certificate of Foreign Government (CFG's)

Still waiting to hear from the FDA. Left a message and sent an e-mail.
 

Qara123

Involved In Discussions
#4
I recently had to add several countries to my CFG and all I had to do was notify CDRH Export Certificates [[email protected]] of the additional countries.
Since there was no "visible change" on the CFG (countries are not listed on the nice green cert), there was no need for me to re-apply.

Even more recently, I had to add a few products to my CFG. Since the products are listed on the nice green cert, I had to re-apply for a new one so that the products gets listed on the CFG.

Not an answer but I hope it clears some of the fog.

Q
 
M

MIREGMGR

#5
Just as with the 510(k) process and concept, the CTFG process and concept are inadequate for the needs of large organizations.

My organization, for instance, develops or otherwise adds a rough average of one new product a day. Fortunately for us, most of our products are not run through the CTFG process, since they're disposable or limited-life accessories for use with $$$ diagnostic imaging systems. As such, they are sold to or through large organizations that focus on the big sales and traditionally ignore such niceties as second- and third-tier national regulatory differences for little stuff like disposables.

If we had to use the existing CTFG process for our product change pace, we would be unable to keep up with customer expectations for development turnaround. We have one large customer that chose to impose the CTFG process on their worldwide activity this year. They're still waiting for us to complete the acquisition of sixteen certificates. In the meantime, the certificates in process have become obsolete in terms of listed products.

We need global harmonization...not among the key first-tier systems in regard to quality systems, but rather especially at the third tier and in regard to commerce-regulatory rules. Consularization, apostillization, notarization, etc., need to go away for products that are certfied conformant at the first tier level.
 
M

markvm68

#6
Re: Updateing Certificate of Foreign Government (CFG's)

After talking with the FDA, it appears that there is no good way around having to update your CTFG everytime you come out with a new product. They did say that one Company could have multiple CFG's. At this point, I think I'm going to propose we have two CTFG's. Our existing CFG which lists our current products and expires in a year, and a new CFG for the new products. When our existing CFG expires, I'll combine them into one.
 
R

red_wood

#7
I have a fundamental question on CFG hoping to get some advice.

What are the requirements that the device need to fulfill in order to get CFG (e.g. manufacturing site is located in US, etc)? Is it true the manufacturing facility need to be audited by FDA within the last 2 years?

Thanks in advance!
 
M

MIREGMGR

#8
What are the requirements that the device need to fulfill in order to get CFG (e.g. manufacturing site is located in US, etc)?
The device and its marketer (the company obtaining the CTFG) must be subject to FDA regulation, and fully compliant and current in regard to that regulation.

Is it true the manufacturing facility need to be audited by FDA within the last 2 years?
No.
 
R

red_wood

#9
Thanks a lot, MIREGMGR.

FDA regulation - does it refer to 21 CFR Part 820 (QSR)?
Is it right that as long as the applicant's company meets QSR and manufacturing site resides in US, they can apply for CTFG for any medical device?

Are there any guidance documents on CTFG application available?

Thanks!
 
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