Medical Device Indications for Use Health Canada

margadia

Starting to get Involved
#1
Hi All,

Hoping to get some clarification here. I work for a US distributor that has exclusive distribution rights in US and CAN to devices sold by an EU manufacturer. They have a device we would like to market in CAN (device is not cleared in US, manufacturer has listed it in CAN), but without a 510k, how would I know what indications the device was cleared for in CAN? The HC device listings aren't like FDA listings, so there is no product info included. Just wondering if there was a way to get that. Thanks!
 
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margadia

Starting to get Involved
#3
The product info is not posted publicly for Canada. If there is an exclusive distribution agreement, why not reach out to the manufacturer directly?
They are on holiday for the week and my marketing team is trying to work on some content and asked me for this information. I had already told them we'd need to wait til they returned, so thank you for backing that up!
 

Ronen E

Problem Solver
Moderator
#4
I guess that the EU IFU would be a pretty safe baseline for any marketing-level device indications. The Canadian system is much closer in nature to the EU one than to the USA one, so it wouldn't be too wild to assume that the Canadian submission was in close resemblance of the EU one (including labeling, claims, indications etc.). This way your marketing team could get to work and most likely when the "official" Canadian indications will come in, in a week or two, it will be mostly a confirmation (at most, little adjustments will be necessary).
 

margadia

Starting to get Involved
#5
I guess that the EU IFU would be a pretty safe baseline for any marketing-level device indications. The Canadian system is much closer in nature to the EU one than to the USA one, so it wouldn't be too wild to assume that the Canadian submission was in close resemblance of the EU one (including labeling, claims, indications etc.). This way your marketing team could get to work and most likely when the "official" Canadian indications will come in, in a week or two, it will be mostly a confirmation (at most, little adjustments will be necessary).
this was almost exactly what i told my marketing team! thank you for your feedback!
 

DannyK

Trusted Information Resource
#6
What is the classification of the device in Canada?
If the product is class II, III or IV, the intended use is required to be stated on the application to Health Canada.
I would ask the EU manufacturer for the intended use statement for Canada.
As a distributor of the device it is a valid question to the regulatory department.
There should be a distribution agreement that allows you to ask these questions.
If the device is an IVD, then the intended use needs to be on the outer package and also on the IFU.
 

margadia

Starting to get Involved
#7
What is the classification of the device in Canada?
If the product is class II, III or IV, the intended use is required to be stated on the application to Health Canada.
I would ask the EU manufacturer for the intended use statement for Canada.
As a distributor of the device it is a valid question to the regulatory department.
There should be a distribution agreement that allows you to ask these questions.
If the device is an IVD, then the intended use needs to be on the outer package and also on the IFU.
Product management let me know yesterday that they've reached out to the marketing team on the mfr's side for IFU information. I guess they finally got the memo after asking me 100x for a better answer, hahah. Thanks for your input!!
 
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