Regulatory Open Forum

Hello RAPS team, 

We are Canada based class I medical devices manufacturer (non sterile, non measuring) and CE marked (Self Declared).

One distributor from Argentina asking for Certificate of Free Sales (CFS).

Does Health Canada issues CFS?
if yes, what is procedure?

If we issue, CFS to Argentina distributor, do we or they still need to comply with their country medical devices regulations?

Your valuable feedback would be highly appreciated.

Thanks 

Hello Anon,

In Canada under Health Canada for medical devices it is a MCE or Manufacturer's Certificate to Export - it is the same as a Certificate of Free Sales (CFS) just called something different by them.  There are certain criteria which needs to be met, but if you have a valid Medical Device Establishment License  (MDEL) then should be fine, more info here on how to submit for one: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/application-manufacturer-certificate-cover-export-medical-devices-0097.html. 

Hello RAPS team, 

We are Canada based class I medical devices manufacturer (non sterile, non measuring) and CE marked (Self Declared).

One distributor from Argentina asking for Certificate of Free Sales (CFS).

Does Health Canada issues CFS?
if yes, what is procedure?

If we issue, CFS to Argentina distributor, do we or they still need to comply with their country medical devices regulations?

Your valuable feedback would be highly appreciated.

Thanks 

Hello Anon,

In Canada under Health Canada for medical devices it is a MCE or Manufacturer's Certificate to Export - it is the same as a Certificate of Free Sales (CFS) just called something different by them.  There are certain criteria which needs to be met, but if you have a valid Medical Device Establishment License  (MDEL) then should be fine, more info here on how to submit for one: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/application-manufacturer-certificate-cover-export-medical-devices-0097.html. 

Hello RAPS team, 

We are Canada based class I medical devices manufacturer (non sterile, non measuring) and CE marked (Self Declared).

One distributor from Argentina asking for Certificate of Free Sales (CFS).

Does Health Canada issues CFS?
if yes, what is procedure?

If we issue, CFS to Argentina distributor, do we or they still need to comply with their country medical devices regulations?

Your valuable feedback would be highly appreciated.

Thanks 

Fyi, the CFS isn't any kind of exemption. As part of their due diligence they just want to know if you're in good standing with your own country's regulator.

Hello Anon,

In Canada under Health Canada for medical devices it is a MCE or Manufacturer's Certificate to Export - it is the same as a Certificate of Free Sales (CFS) just called something different by them.  There are certain criteria which needs to be met, but if you have a valid Medical Device Establishment License  (MDEL) then should be fine, more info here on how to submit for one: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/application-manufacturer-certificate-cover-export-medical-devices-0097.html. 

Hello RAPS team, 

We are Canada based class I medical devices manufacturer (non sterile, non measuring) and CE marked (Self Declared).

One distributor from Argentina asking for Certificate of Free Sales (CFS).

Does Health Canada issues CFS?
if yes, what is procedure?

If we issue, CFS to Argentina distributor, do we or they still need to comply with their country medical devices regulations?

Your valuable feedback would be highly appreciated.

Thanks