M
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!
Mike
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!

Mike