Free Sale Certificate FSC / CFS - China

M

Mike_Benz

#1
Hello everyone!!

I have a tough question.

We develop our products in the USA, and give the specs / processes to our ISO 13485 company in China, who contracts and supervises the production of our products through a variety of non-company owned production plants. We list the address of our Shanghai office on our label as the manufacturer.

Here's the issue - we need to obtain Free Sale Certificates for our products with our sister company in China listed as the manufacturer on the document and NOT listing the name of the actual physical factories on the document (trade secret). As we do not sell within China, and are not the physical manufacturer (but rather, the manufacturer of record and registered entity who is both legally and financially liable), we have not been successful in getting Free Sale Certificates with our company on the document. So, we would have to give up our source which would make us very vulnerable and reduce the likelihood of repeat business.

Has anyone had this type of issue before? Any suggestions for how our China office can obtain FSC with itself listed on the label.

What we have done so far:
- Listed our company with the US FDA.
- Register our products with the USFDA.
- Therefore, we can generate a Certificate to Foreign Government (CFG), which could be used to replace the Free Sale Certificate. HOWEVER, if the product does not have 510k, then we can not register it and therefor not put it on the CFG! More, the CFG is being phased out and replaced by UDI codes. As a result, we are setting up to get UDI codes but still, none of our higher risk products without 510k can be included!

Any insight and guidance would be so helpful.

Thank you! :thanx:


Mike
 
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M

MIREGMGR

#2
More, the CFG is being phased out and replaced by UDI codes.
Really? The two systems don't do at all the same thing.

Now, to your questions:

We develop our products in the USA, and give the specs / processes to our ISO 13485 company in China, who contracts and supervises the production of our products through a variety of non-company owned production plants. We list the address of our Shanghai office on our label as the manufacturer.

Here's the issue - we need to obtain Free Sale Certificates for our products with our sister company in China listed as the manufacturer on the document and NOT listing the name of the actual physical factories on the document (trade secret). As we do not sell within China, and are not the physical manufacturer (but rather, the manufacturer of record and registered entity who is both legally and financially liable), we have not been successful in getting Free Sale Certificates with our company on the document.
Are you asking China FDA to issue the FSC? Where do you want to market, and do they accept China FDA FSCs?

What we have done so far:
- Listed our company with the US FDA.
- Register our products with the USFDA.
This is backwards...you Register a company, and List products. It doesn't affect the substance of your questions, but you might as well get the terminology right.

Therefore, we can generate a Certificate to Foreign Government (CFG), which could be used to replace the Free Sale Certificate.
I don't think this is correct. If the product itself is not made in USA, marketed in USA or exported from USA, it is not eligible for CFG or an equivalent US FDA certification, irrespective of any other connection of the responsible company to USA.

HOWEVER, if the product does not have 510k, then we can not register it and therefor not put it on the CFG!
I'm not getting the logic flow here. Certainly it's possible to make a device in USA for export only, of a type that would require 510(k) for USA marketing, and get a Certificate of Exportability from FDA in the absence of a 510(k).

Of course, if the point of the certification from the perspective of the foreign country is that the device is legally marketable in USA, then obviously if it's of a type that requires 510(k) clearance and you don't have such clearance, you aren't going to satisfy the foreign country's requirements.
 
M

Mike_Benz

#3
Hello Miregmgr,

Thank you for your thoughtful response. To answer your questions 1 at a time:

1 - the USFDS CFG export documents are being phased out within the next few years. They will not be replaced UDI codes. I don't quite understand it, but our QA/RA consultants insist on this is the direction.

2 - Yes. China FDA FSC (country of origin FSC, we manufacture and export out of China). Which markets? All that require them. At the moment, for Oman FDA.

4 - Thank you. You are correct. The Company was registered and products listed.

5 - CFG can be legally obtained.

6 - We are attempting to us CFG to replace FSC China but it is not entirely helpful as we can not list products that require but do not have 510k on our export document, as you said, saying validating that it is marketable in the US)

***Would you know how one must set up their company in China to be eligible to obtain China FDA FSC?

From your comments, I gather many Country FDA's don't accept China FSC. Do you have a resource that lists these countries.

Thank you!
 
Last edited by a moderator:
M

MIREGMGR

#4
Would you know how one must set up their company in China to be eligible to obtain China FDA FSC?
Sorry, I do not.

From your comments, I gather many Country FDA's don't accept China FSC. Do you have a resource that lists these countries.
I do not. My comment was based on experience as to what will be accepted, i.e. a regulatory clearance from a first-tier regulatory system such as US FDA or CE Mark, or in some Eastern European and Asian countries, Russian GOST-R.
 
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