Are we required to obtain a Certificate of Free Sales for export to China?

[CO QA]

Hi - We are a manufacturer of 501K exempt class 1 medical devices. Are we required to obtain a Certificate of Free Sales for export to China?

Thanks!

K

 

[somashekar]

Hi - We are a manufacturer of 501K exempt class 1 medical devices. Are we required to obtain a Certificate of Free Sales for export to China?

Thanks!

K

Depends on your Importer / Customer.
We had obtained it once upon our customer request in India and thereafter it was not asked.

 

[CO QA]

Thank you, we have experienced the same thing.

K

 

[sreenu927]

In order to sell a medical device, it requires registration following CFDA regulations. For registration, one of the mandatory documentation requirements is - Free Sales Certificate/CFG from Country of Origin.

I hope this helps!

Regards
Sreenu

 

[supadrai]

In order to sell a medical device, it requires registration following CFDA regulations. For registration, one of the mandatory documentation requirements is - Free Sales Certificate/CFG from Country of Origin.

I hope this helps!

Regards
Sreenu

This is consistent with our experience in China.

Also:

Serbia
Peru
Sudan
KSA - but must come from the EU (other proofs of registration are acceptable)
Nigeria
Colombia

That's just from a quick scan of my inbox since April this year.

 

[TheCuriousMind]

Hi, just to continue with discussion i am curious is there a way to tell whether or not a certain FSC issued is fake or not? If there is how can we tell?

 

[supadrai]

If the countries you are dealing with are not members of the Hague Apostille convention, the original document will need to be certified by the Ministry of Foreign Affairs (or similar) of the country of origin and then "Notarized" by the embassy/consulate of the country of destination. If the certificate can survive these processes, then it is an amazing forgery.