Free Sale Certificate - China, Vietnam, Philippines and Thailand

#1
Hi mates,

We subcontracted our manufacturing process of medical devices to our approved vendor. We are consider is the legal manufacturer in this case.

We are facing problem of applying Free Sale Certificate in China, Vietnam and Philippines and Thailand whereby the FSC could not put us as the manufacturer but our subcontractor as required by the respective authorities. This is not our intention to disclose our subcontractor name in the FSC. How can we go about it?

Or alternatively, can we use other documents to substitute FSC in these countries mentioned?

:thanx:

Tiffany
 
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sreenu927

Quite Involved in Discussions
#2
The purpose of the FSC (at least for the below mentioned countries' registration) is to show evidence that the product is freely sold in the country of ORIGIN.

However, some medical device companies (like yours) will OEM the manufacturing process, where they are located in a different country.

I am not sure in which country is your contract manufacturing facility located and what is the format of the FSC that country's regulatory authority is providing.

In my experience, there are two options to resolve your issue:
1. FSC issued in the country of origin (contact manufacturing location) with the specific information about the Physical Manufacturing Site (OEM/Contract MFG site name and address), Product Owner or Legal Manufacturer (your company name and address) and the product name/catalogue number and the phrase, "freely sold in <country>" or a similar phrase to indicate that the product is freely sold in the country of origin.

2. a) FSC from the country of legal manufacturer with the information about the physical manufacturing site, product owner/legal manufacturer, product name, catalogue number and the phrase of freely sold in <country>.
b) Country of Origin (COO) Certificate from the OEM Country with physical manufacturing site name and address, product owner name and address.

In both the cases, you can't avoid the contract manufacturing site name and address. Even though, if you wrongly declare that there is no outsourcing (I believe you won't do that), during your shipment of products, if the customs department finds the discrepancy in the country of origin, then it will cause more problems.
Else you discuss with your counterpart in those countries - what other documents do their regulatory authorities accept.

Regards,
Sreenu
 
#3
Hi Sreenu,

The OEM is in Canada and the legal manufacturer is in Italy and it will be distributed in the said countries.

Wanted to further clarify from you in order for confirming whether I get it right:-

For Option2:
Meanings to say I can apply FSC (with the legal manufacture address in Italy) and Certificate of Origin (with the subcontractor in Canada as the manufacturer details).

May know if you experience the same in the said countries (China, Vietnam, Philippines and Thailand)? The most important intention is that our OEM would not intend to disclose their name in any of the documentation for registration submission.

Appreciate you can share this with us here!

Thanks again.
 

sreenu927

Quite Involved in Discussions
#4
Hi Tiffany,

YEs, FSC from Italian Regulatory Authority. The FSC should have the details of legal manufacturer as Italy company name and address and the Canada OEM name and address. The COO from Canada Govt. Authority or Chamber of Commerce in Canada.

This approach had worked for Thailand. I believe same would work for China, and others too.

Regards,
Sreenu
 

LFZR88

Involved In Discussions
#5
Hi all
Sorry for hijacking this thread, I need some advice on China

Please can anyone help me with the process for obtaining legalisation on a Certificate of Free Sale for Medical devices for China? We are based in France and cannot get hold of the Chinese embassy in Paris to find out if this is correct. We believe that we need to follow the process stated below

Step 1 - Creation of Certificate with ANSM,
Step 2 - Chamber of Commerce Stamp,
Step 3 - Legalisation of ANSM signature by Ministry of Foreign Affairs
Step 4 ? Chinese Embassy stamp

Does anyone have any experience with dealing with the Chinese embassy in Paris, how have you had documents stamped by them? Can we courier them or do we have to be there in person, have we got the process correct?? :thanks:
 

sreenu927

Quite Involved in Discussions
#6
Hi..
I don't have any experience with China Embassy in Paris.

Usually, Chinese Regulatory Authorities (CFDA) seek "Notarisation" of documents, not legalisation. You please confirm with your distributor/agent in China.

Regards,
Sreenu
 
#7
As China, Vietnam, Philippines and Thailand not part of the huge convention countries it require the FSC to be legalized this mean it should be certified from a formal authority like FDA in US or by a local chamber of commerce like chamber Net then the documents must be certified from us department of state or ministry of foreign affairs and then authenticated from the china embassy. You could search for expedite services company like China Authentication Services - they relay help
 
#8
Hello,

Sorry to interrupt the thread but it seems I may get the hell I need here.

My company is currently working with a manufacture in China to import a skincare product into Nigeria. We require a CFS for a product we are trying to import and register with the National Agency of Food and Drugs Administration in Nigeria (NAFDAC)

The Chinese manufacture don’t have a CFS and we are stuck at the moment. Can anyone provide details on the following;

-How can we get a CFS for our product?

-Can our company make an application or must the manufacture do so?

-Lastly are there alternative to the CFS?

Thank you in advance!
 
#9
Hello ZBN,

The Manufacturer needs to apply for the CFS and then will probably need to have it legalized at the Nigerian Embassy (Beijing) or Consulate (Guangzhou) in order for it to be accepted by NAFDAC.

This can be time consuming and costly for them and they may not know how to do it correctly. Alternatively, the product is not able to be sold within China, in which case they CFDA will not issue a CFS. In that case, (and I am not sure of this procedure) you can find another country where your product is sold (and regulated) and obtain a CFS from there, which should be acceptable to NAFDAC.

I hope this is helpful.
 
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