Medical Device License as Distributor

margadia

Starting to get Involved
#1
Hello! Thanks, in advance, for any and all feedback! I am the Quality Manager of a US medical device company. We do not manufacture any devices. We purchase devices from manufacturers overseas and then facilitate the import of them into the US for distribution to customer sites. We do not store, handle or distribute any of the devices ourselves, we outsource this to a 3PL. We are registered with USFDA as an Initial Importer/Distributor. My company is interested in acquiring MDSAP and 13485 certification as one of our suppliers, the legal manufacturer of a device, is not licensed in Canada (and does not have MDSAP). My understanding is if the legal manufacturer is not licensed in Canada, we cannot sell the device in Canada. My question is, if we, the importer/distributor of the device, were to obtain MDSAP and 13485 certification, are we able to apply for a Medical Device License and sell the device in Canada ourselves? Your feedback is appreciated!
 
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MedicalDevicesCanada

Starting to get Involved
#2
The manufacturer should have MDSAP.
If the manufacturer is ready to whitelabel this device for your company, and you would become the manufacturer on the label, manual, IFU, you will have the trademark of that device - then you can use MDSAP certificate created for your company.
 

margadia

Starting to get Involved
#3
If we were to do this, would we be able to apply as a private label device manufacturer and submit an attestation from the original manufacturer to the ministry or do we then become liable for all aspects of the manufacturer's regulatory responsibilities?
 

DannyK

Trusted Information Resource
#5
Hello! Thanks, in advance, for any and all feedback! I am the Quality Manager of a US medical device company. We do not manufacture any devices. We purchase devices from manufacturers overseas and then facilitate the import of them into the US for distribution to customer sites. We do not store, handle or distribute any of the devices ourselves, we outsource this to a 3PL. We are registered with USFDA as an Initial Importer/Distributor. My company is interested in acquiring MDSAP and 13485 certification as one of our suppliers, the legal manufacturer of a device, is not licensed in Canada (and does not have MDSAP). My understanding is if the legal manufacturer is not licensed in Canada, we cannot sell the device in Canada. My question is, if we, the importer/distributor of the device, were to obtain MDSAP and 13485 certification, are we able to apply for a Medical Device License and sell the device in Canada ourselves? Your feedback is appreciated!
Yes this is possible and this is something I do for many distributors in Canada.
It is possible if the original supplier has ISO 13485:2016 and is willing to share their technical file, design development and production procedures and records.
 

margadia

Starting to get Involved
#6
Yes this is possible and this is something I do for many distributors in Canada.
It is possible if the original supplier has ISO 13485:2016 and is willing to share their technical file, design development and production procedures and records.
And so then we would need to also change our FDA registration to manufacturer correct?
 

margadia

Starting to get Involved
#7
And so then we would need to also change our FDA registration to manufacturer correct?
Edit: We are currently listed as the complaint file establishment for the device. Do we need to go through the whole 510k process to facilitate the change in name on the labeling?
 

DannyK

Trusted Information Resource
#8
Are you considered the manufacturer in USA or are you just the distributor ?
If you are only the distributor then you do not need to change anything.
 

Highground

Involved In Discussions
#10
We have a supplier that manufacturers devices with only ISO-13485, but we were able to add them to our MLD license as our supplier.
We have MDSAP Certification.
They have on the labeling that they are the manufacturer and our company name on the product.
 
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