Certificate of Foreign Government (Distributor in Mexico)

K

katastic

#1
Good afternoon, Can anyone help me with this. We have a distributor in Mexico, we have obtained the proper CFG from the FDA, I was just wondering, does the CFG stay with us here or does it need to be given to our distributor in Mexico? I really appreciate your help, thank you:bigwave:
 
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AnaMariaVR2

Trusted Information Resource
#2
I would say that it goes to Mexico to their agency...is the distributor going to submit it to the agency?

Do you have a local subsidiary that could submit it directly to the agency so it goes directly from the sponsor to the agency? I'm assuming you are the sponsor but I don't know...never assume, right?

Also it depends on how the contract between your company & the distributor in Mexico has been established. Have someone look into those details. Where does the responsibility falls?

Here is a sample of a CFG issued by FDA:
http ://www .brownmed .com/ files/9413/3710/4992/Certificate_to_Foreign_Government.pdf - DEAD LINK - Try Certificate_to_Foreign_Government.pdf at DuckDuckGo

Also check what type of legalization requirements the agency needs...lately Mexico has tighten up their requirements. Once you have your CFG, scan it & keep an electronic file of it as copy/proof of what will be submitted to Mexican agency. Also not a bad idea to check with Mexican agency on how they want this CFG document so you requested as they will need to obtain it.

Good luck
 
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E

evilchilli_420

#3
I completely agree with everything AnaMariaVR2 has indicated. My :2cents: is

a. Are you going to distribute the product only in Mexico? - Then you can send the CFG to the distributor in Mexico.

b. If your firm is the legal manufacturer of the device and if you're registering the product in other countries in that name, you should own the CFG and send it to the countries as needed for registration.

c. Sometimes Mexico needs the CFG to be apostilled. Work with your distributor on the requirements.

Hope this clarifies.


Thanks,
N


I would say that it goes to Mexico to their agency...is the distributor going to submit it to the agency?

Do you have a local subsidiary that could submit it directly to the agency so it goes directly from the sponsor to the agency? I'm assuming you are the sponsor but I don't know...never assume, right?

Also it depends on how the contract between your company & the distributor in Mexico has been established. Have someone look into those details. Where does the responsibility falls?

Here is a sample of a CFG issued by FDA:
http: // www. brownmed .com/ files/9413/3710/4992/Certificate_to_Foreign_Government.pdf - DEAD LINK

Also check what type of legalization requirements the agency needs...lately Mexico has tighten up their requirements. Once you have your CFG, scan it & keep an electronic file of it as copy/proof of what will be submitted to Mexican agency. Also not a bad idea to check with Mexican agency on how they want this CFG document so you requested as they will need to obtain it.

Good luck
 

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