Regulatory Open Forum

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

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Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
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Hi Steven,

I work for Latin America.  Where is the manufacturing of the products?

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Mayra Cartagena
Hill-Rom
Miramar FL
United States
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Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

Hi Steven,

Some EU Competent Authorities will issue FSCs to any manufacturer, while others, such as the MHRA, will only issue to domestic manufacturers. If your AR happens to be in the UK or another country that will not issue a CFS to foreign manufacturers, it can pose a problem. One option is to change the location of the AR, or change ARs.

Good luck.

M.S

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Michael Siano
Emergo Group
Austin TX
United States
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Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

Hi Steven,
I just went through a similar situation with a client who makes a device in U.S. but does not sell in U.S.  The device carries CE marking, and they want to sell in Latin America.  However, in our case the EU Authorized Representative did obtain a Free Sale Certificate with apostille.  In my opinion, the AR charged a high fee to do this, but it was done in an expeditious manner.

So I suggest you challenge your AR on this point.  Suggest that they talk to their competent authority on how to obtain the Free Sale Certificate.  Also, you may want to check with the countries where you want to register, to confirm whether or not they require an apostille for the certificate.

Regards,
Laura

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Laura Halper PhD
Consultant
Halper Group
Plano TX
United States
-------------------------------------------


Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

Steven,

Your authorized representative should be able to obtain a FSC for you. You are not required to manufacture in the EU in order to obtain one, however since you are based in the US the request must come from your authorized representative. The FSC, just like a CFG in the US, is given to prove that you have legally marketed product (i.e. CE mark) on the market.  Please see MDSS.com website for further information.

Regards,

-------------------------------------------
Denise Hebert RAC
Regulatory / Medical Manager
Beaver-Visitec International, Inc (BVI)
Waltham MA
United States
-------------------------------------------


Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

We recently received the following information from our UK-based AR: 


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Diane King RAC
VP, Regulatory Affairs
Gynesonics Inc.
Redwood City CA
United States
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Original Message:
Sent: 12-12-2014 13:35
From: Denise Hebert
Subject: Free Sales Certificate

Steven,

Your authorized representative should be able to obtain a FSC for you. You are not required to manufacture in the EU in order to obtain one, however since you are based in the US the request must come from your authorized representative. The FSC, just like a CFG in the US, is given to prove that you have legally marketed product (i.e. CE mark) on the market.  Please see MDSS.com website for further information.

Regards,

-------------------------------------------
Denise Hebert RAC
Regulatory / Medical Manager
Beaver-Visitec International, Inc (BVI)
Waltham MA
United States
-------------------------------------------


Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

You can obtain the Certificate of Exportability from FDA. This certificate will allow you to export devices from the US that are not 510k approved.
For registrations in LA and Middle East you will need to provide your CE certifications so you can register using CE pathway vs FDA/510k.

Hope this helps.

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Kristina Fink
Sr Regulatory Specialist
Natus Medical Incorporated
Madison WI
United States
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Original Message:
Sent: 12/11/2014 10:02:11 AM
From: stevenavi@hotmail.com
Subject: Free Sales Certificate

Hi Everyone, We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability. So, does anyone know of any other options that might be acceptable? Thanks and appreciation in advance, Steve ------------------------------------------- Steven Goldberg RAC, MBA, PMP Regulatory Affairs Manager Nova Biomedical Newton MA United States -------------------------------------------

Hi Steven,

I don`t know if you are still looking for answers with regards to the topic below..? It is correct that some EU countries do not issue FSC any more for non-EU companies, such as the UK. This, however, is not a generic rule as of today. We, for example, are an EU Auth. Rep. located in Germany and apply for FSC on behalf of our clients on a regular basis.

I hope that helps..

-------------------------------------------
Michael Sander
VP Sales & Marketing
Mdi Europa Gmbh
Langenhagen
Germany
-------------------------------------------


Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

We were able to gain FSCs from our Authorized EC Rep for the country they sit in - Netherlands. We are a US based manufacturing company with only distributors in Europe...

Not sure how accurate that advise was initially...

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Jose Cabrera
Senior Director - RA/QA
Somahlution
Palm Beach Gardens FL
United States
-------------------------------------------


Original Message:
Sent: 12-17-2014 09:53
From: Michael Sander
Subject: Free Sales Certificate

Hi Steven,

I don`t know if you are still looking for answers with regards to the topic below..? It is correct that some EU countries do not issue FSC any more for non-EU companies, such as the UK. This, however, is not a generic rule as of today. We, for example, are an EU Auth. Rep. located in Germany and apply for FSC on behalf of our clients on a regular basis.

I hope that helps..

-------------------------------------------
Michael Sander
VP Sales & Marketing
Mdi Europa Gmbh
Langenhagen
Germany
-------------------------------------------


Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

Hi,

I've read through all the posts on this blog and have a similar issue, however, our Authorized Rep is not able to request a certificate for Costa Rica.  We have a product that is manufactured in Germany with legal manufacturer located in the US.  We do not promote, market or sell the product in the US.  We do, however have catalog numbers for this product that are distributed from our US facility specifically for Latin America.  Our Authorized Rep is in France.  For Costa Rica, they will only accept a certificate from where the legal manufacturer is (US) or manufacturing facility (Germany).  A FDA Certificate of Exportability is not acceptable. A Free Sales Certificate from France is not acceptable.  Are there other options available?

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Jeme Wallace
Director, Reg Affairs
Cary IL
United States
-------------------------------------------


Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------

Jeme, 

It is worth trying.

You may want to call the Dept of Commerce in IL whether they can issue a CFS (Certificate of Free Sale) or FSC.  You may also want to try trying your own self-certification and then get it legalized through the Costa Rica Embassy.

Consulate General of Costa Rica
Address: 2112 S Street, NW - Washington, D.C. 20008.
Phone: (202) 499-2991. Fax: (202) 265-4795.

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 12-18-2014 17:30
From: Jeme Wallace
Subject: Free Sales Certificate

Hi,

I've read through all the posts on this blog and have a similar issue, however, our Authorized Rep is not able to request a certificate for Costa Rica.  We have a product that is manufactured in Germany with legal manufacturer located in the US.  We do not promote, market or sell the product in the US.  We do, however have catalog numbers for this product that are distributed from our US facility specifically for Latin America.  Our Authorized Rep is in France.  For Costa Rica, they will only accept a certificate from where the legal manufacturer is (US) or manufacturing facility (Germany).  A FDA Certificate of Exportability is not acceptable. A Free Sales Certificate from France is not acceptable.  Are there other options available?

-------------------------------------------
Jeme Wallace
Director, Reg Affairs
Cary IL
United States
-------------------------------------------


Original Message:
Sent: 12-11-2014 10:02
From: Steven Goldberg
Subject: Free Sales Certificate

Hi Everyone,
We are a US-based manufacturer looking to register product (CE-marked but not FDA-cleared) in some Latin American and Middle East countries that are requiring a Free Sales Certificate. I understand from our EU Authorized Representative we cannot obtain a FSC because we do not manufacture in that country. And these countries do not accept the FDA Certificate of Exportability.
So, does anyone know of any other options that might be acceptable?
Thanks and appreciation in advance,
Steve

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Newton MA
United States
-------------------------------------------