MDEL License Holder Address

margadia

Involved In Discussions
Question about MDEL inspections. We recently received communication from an inspector in Canada requesting information on why we chose the physical location of our MDEL to be in Vancouver. We replied it was our legal agent's address. The inspector quickly requested information on why we have a legal agent in Canada, if we have an agreement in place with the agent, what involvement would they have in the inspection and what details with respect to Medical Device Regulations are written in the agreement. We do not hold the approvals for the devices we sell in Canada. We are a distributor and the manufacturers of the devices all are all active on MDALL. I suspect the inspector is inquiring about the agent because of this, we simply utilize their service to have someone with local regulatory knowledge to advise, if needed, and of course, to use their address for the MDEL license. I'm not familiar with anything in the regulations or application instructions that state we cannot use this address. Is this incorrect? This agent will have no involvement in our inspection, and as far as Medical Device Regulations, we utilize our own regulatory team in the US, so we do not require the agent to provide any assistance with respect to MDR. My question is, do we need our own physical location in Canada or is using the agent's address compliant? If so, are we able to just use our US address in that case? Should we be concerned that we do not intend to have the agent involved in any capacity with this inspection and do not have any verbiage in an agreement with respect to MDR? Your feedback is appreciated!
 

margadia

Involved In Discussions
I'd like to correct something above. I originally wrote that we are a distributor, however we are listed as an importer on our MDEL. From reading the guidance on MDEL, would we instead be a distributor?
 

DannyK

Trusted Information Resource
Need to add your address in USA. Canadian agent address should not be part of the MDEL application.
 

margadia

Involved In Discussions
Need to add your address in USA. Canadian agent address should not be part of the MDEL application.
We have the agent listed in Section 1 and then our US address listed under Section 2 Establishment address. So we should amend to have the US address in both?
 

DannyK

Trusted Information Resource
The agent's address should not be on the application.
Section 1 of the MDEL application does not have a field to complete the address.
Section 2.1 should be completed with your address.
Since you are not located in Canada, you cannot be an importer.
 

margadia

Involved In Discussions
The agent's address should not be on the application.
Section 1 of the MDEL application does not have a field to complete the address.
Section 2.1 should be completed with your address.
Since you are not located in Canada, you cannot be an importer.
thanks again, I have a call scheduled with the inspector so I'll get this all sorted.
 
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