Sale of Class I device to end users in Canada

[SBaircraft]

I manufacture a Class I device in the USA. It is my understanding that I need a MDEL to sell the product to Canadian retailers. However, I may not require an MDEL to sell directly to end users in Canada. In this case, the end user would be acting as the importer.

What if I ship my product to an Amazon FBA warehouse in Canada, and from there, fulfill orders to end users? On the one hand, this would still be a sale to an end user. However, I would be the importer and I would still own the product while it is in the Amazon FBA warehouse. Does anyone have any thoughts on whether an MDEL would be required in this case?

 

[DannyK]

If the product is class I in USA, there is a chance that it is not class I in Canada.
You need to classify the products as per SOR98/282.
I worked with a company in the KK that was in a similar situation and was told by the company that Amazon insisted on them to obtain an MDEL.
I helped them with the process and they started selling in Canada shortly after.

 

[Nichole F]

DannyK is correct. Make sure your product is also class I in Canada as they have different classification guidelines. See Schedule 2 of SOR/98-282.

If you are not selling your product under Amazon's MDEL, you as the manufacturer will need an MDEL (assuming your device is class I in Canada; otherwise you will need an MDL). Also, as a US based manufacturer, you cannot be the importer.