Medical Device Certificates of Free Sale - Distributors

JoCam

JoCam

Trusted Information Resource
Hi All,

Is it always the manufacturer of a medical device that needs to request a certificate of free sale through the MHRA, or can a distributor do this?

Jo
 
JoCam

JoCam

Trusted Information Resource
Hi dgrainger,

I always do my research before asking for help on the Cove. I've read these guidelines, but they aren't clear about whether a CFS must always be sought by the manufacturer, and whether or not it is acceptable for the distributor to do this.

Thank you anyway,

Jo
 
moounir

moounir

Involved In Discussions
JoCam said:
Hi dgrainger,

I always do my research before asking for help on the Cove. I've read these guidelines, but they aren't clear about whether a CFS must always be sought by the manufacturer, and whether or not it is acceptable for the distributor to do this.

Thank you anyway,

Jo
Click to expand...
As the products belong to the manufacturer I would bet that only him can ask for that document but sure that you can try. For me the reason is that the manufacturer needs to know where his products are sold. If any distributor can get a CFS without the manufacturer knowing, I assume there can be some abuse.

Anyway, to register a product in another country you'll need a lot of documents that are belonging to the manufacturer so quite difficult to do without him.

Let me know what you think.
 
JoCam

JoCam

Trusted Information Resource
Hi moounir,

Thank you for your response.

I am the manufacturer and a Distributor is looking to sell the product in Saudi Arabia. As a part of the registration process for the device they have obviously been asked for a certificate of free sale. This is the reason for the question. Can they obtain the CFS, or does it have to come from me?

Jo
 
supadrai

supadrai

Lawyer
JoCam said:
Hi moounir,

Thank you for your response.

I am the manufacturer and a Distributor is looking to sell the product in Saudi Arabia. As a part of the registration process for the device they have obviously been asked for a certificate of free sale. This is the reason for the question. Can they obtain the CFS, or does it have to come from me?

Jo
Click to expand...

We (Thailand manufacturer) just provided a German CFS to our distributor in KSA. Not sure whether they could obtain it themselves, but I've never seen it in practice.
 
moounir

moounir

Involved In Discussions
JoCam said:
Hi moounir,

Thank you for your response.

I am the manufacturer and a Distributor is looking to sell the product in Saudi Arabia. As a part of the registration process for the device they have obviously been asked for a certificate of free sale. This is the reason for the question. Can they obtain the CFS, or does it have to come from me?

Jo
Click to expand...

As the other and yourself I am on the manufacturer side and never been told by a distributor that they can obtain a CFS on my behalf. And I am really happy of that as I can then control where my product is sold.

But I assume that if you provide to this distributor all the necessary documents he can request them by himself.

When I looked at the MHRA website to see if they ask only Manufacturers to request CFS, I find that the answer is NO. They tell that you can be another organization asking for the CFS on behalf of the manufacturer but you need to define your relationship. Link

I hope this helps to move the needle.
 
moounir

moounir

Involved In Discussions
moounir said:
As the other and yourself I am on the manufacturer side and never been told by a distributor that they can obtain a CFS on my behalf. And I am really happy of that as I can then control where my product is sold.

But I assume that if you provide to this distributor all the necessary documents he can request them by himself.

When I looked at the MHRA website to see if they ask only Manufacturers to request CFS, I find that the answer is NO. They tell that you can be another organization asking for the CFS on behalf of the manufacturer but you need to define your relationship. Link

I hope this helps to move the needle.
Click to expand...

Hi JoCam,

I just looked at the terms and conditions on the MHRA website and it says:
2.2 Registration with the Online Certificate of Free Sale system allows manufacturers of medical devices, or their authorised representatives to create an account as a CFS Service User of the system by providing contact details and other relevant company information, which the MHRA will evaluate independently.
Click to expand...

So if your distributor is not your authorized representative (Thing that I also do not recommend: Check my article here: Top 11 Questions on European Authorized Representatives (Medical Devices)), then he should not be allowed to do it. But this is only what I understand from this sentence.
 
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