Have you ever received a request to provide a Certificate of Free Sale (CFS) or Free Sale Certificate (FSC) while you are trying to register your Medical Device outside of your country?
And I am sure you jumped on google to understand what it is and how to get it.
On this article, I will
- Help you get the information about Free Sale Certificates
- And also how to find them for your country.
I will use the example of the European Union, but all countries are asking the same. On the Medical Device Regulation MDR 2017/745, you can find on Article 60 more information about Certificate of Free Sale.
On IVDR 2017/746 you can find the same information on Article 55.
By the way, on my research, I checked if this was mentioned on the MDD 93/42/EC and couldn’t find it. The Certificate of Free Sale is something asked since a long time, but apparently only now you can find it on the Regulation.
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Table of content
- What is exactly a Certificate of Free Sale?
- Who can ask for this Certificate of Free Sale?
- Where to ask this Certificate of Free Sale?
- Which products are authorized to get a Certificate of Free Sale?
- What should contain the Certificate of Free Sale?
- What is the format of the Certificate of Free Sale?
- How to ask for the Certificate of Free Sale?
- European Union
- Asia
What is exactly a Certificate of Free Sale?
The Certificate of Free Sale (CFS) or Free Sale Certificate (FSC) is evidence that goods, such as medical devices are legally sold or distributed in the open market, freely without restriction, and approved by the regulatory authorities in the country of origin.
Many countries ask for this evidence before you can register your product.
Who can ask for this Certificate of Free Sale?
The person that can require it is the Manufacturer or its Authorized Representative. It is important to keep the access to this document restricted to both as this document is sesame to register products anywhere.
Where to ask this Certificate of Free Sale?
The Certificate of Free Sale can be issued by the member state where the Manufacturer or Authorized Representative do have their place of business.
Check this article about Top 11 questions about the European Authorized Representative, to have a better understanding about the role and responsibility of an authorised representative.
So if you, as a manufacturer, are located in France, you’ll need to request this document to the French government.
In the case you are located outside of Europe, it’s your Authorized Representative that has the right to ask for it. Same as the previous case. If your Authorized Representative is located in Spain for example, he will need to ask the Spanish government for it.
To help you, at the end of this article I list all the websites of the member states that I found. Please help me to improve it.
Which products are authorized to get a Certificate of Free Sale?
If your product bears the CE mark and if it is marketed inside the European Union, then it can get a Certificate of Free Sale.
But this is not only applicable to Medical Devices. This is applicable to any goods.
So if you have furniture that needs to be exported to another country, the receiving country can also ask for a Certificate of Free Sale.
What should contain the Certificate of Free Sale?
As now we have to implement the UDI in Europe, the Certificate of Free Sale should contain the Basic UDI-DI of your product.
If you want to know more about the Basic UDI-DI you can read this article or also listen to my podcast episode 4 below. I also included the video with audiogram that I published on my Youtube Channel.
Additionally, if your product is higher than class I, it should also contain the unique number identifying the Certificate of Conformity issued by the Notified Body.
This is the number that you’ll see on your CE certificate issued to certify that you comply to the Medical Device Regulation MDR 2017/745 or IVDR 2017/746.
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What is the format of the Certificate of Free Sale?
There is no specific format for now. Each member state can issue their version. But the MDR and IVDR are mentioning that the European Union can create a model by means of implementing acts.
But anyway this is something that the Member States will have to take into account when they will issue that for the manufacturer or authorized representative.
How to ask for the Certificate of Free Sale?
As mentioned before, you need to request that to the member state of your place of business.
Below I present you a list of some Member States with the link to ask for the Certificate of Free Sale. The trick is that in some countries, the website is only on the local language so it can be tricky to find the right information.
I would need your support if you see that your country is not listed. If by chance you find the right link, can you please post that on the comment. I will then update this page to include your country. I tried to look at many countries but the language barrier stopped me and I think now I need the community to help.
Even if your country is outside of the European Union, I can list that here. Thanks for your collaboration.
European Union
Asia
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Link for Certificate of Free Sale
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
