Renewal of Canada Manufacturer Licence if there is no Sales (Only Support)

sagai

Quite Involved in Discussions
#1
I wondering if manufacturing license should be renewed for Canada if there is no sales only support for the existing customer base.
Many thanks in advance.
 
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M

MIREGMGR

#2
What does "support" mean?

You run a website where customers can review documentation, or maintain a Customer Service/Tech Support phone number where they can ask questions?

You send out technicians to customer sites and repair/calibrate their existing equipment?

You send out replacement units to customers that have issues?

The Health Canada rules govern advertising in Canada, sales in Canada and importation into Canada. In the first two cases above, you wouldn't seem to need to do either activity. In the third case above, I think Health Canada might see such a transaction as a "constructive sale" in a legal sense, and importation of new units into Canada to replenish the service-stock might additionally be required.
 

sagai

Quite Involved in Discussions
#3
I am trying to elaborate my question in more details.

When the Manufacturer is about not to accept any sales order from any potential or recent Customer as regard to Medical Device.
There is no accessory, no replacement unit, due to the nature of the MD, because its purely software.

However, the Manufacturer would like to support to existing Customer base with the ongoing Hotline service including but not limited to the Customer Call Center, Web site and in case of necessity with on-site service engineering support.

So, that's what I have intended to tag as no sales only support situation.

There is no direct advertising, no sales and no importation, but support activities.

Many thanks in advance.
 
M

MIREGMGR

#4
I don't know the answer, and I don't think the question is answerable just from SOR 98/242. You might need a legal opinion.

Others might know differently, though.

What will you do about upgrades and patches? Are upgrades and patches insignificant, or are they the software equivalent of replacing an old physical product version with a newer version?
 

sagai

Quite Involved in Discussions
#5
Thank you very much for your reply.
Actually there are no upgrades, no patches, surprisingly it is rock solid.
Many thanks, Cheers
 

RA Guy

Involved In Discussions
#6
From the CMDR:
APPLICATION
 
2. These Regulations apply to
(a) the sale and advertising for sale of a medical device; and
(
b) the importation of a medical device for sale or for use on individuals, other than importation for personal use

As soon as active selling and distribution have ceased, I have always alowed the MDL to lapse at the next renewal period, regardless of its support requirements. By my interpretation, this applies even in the case of products that require support in terms of repair parts and service, software patches, etc. Complaints, recall, MPR, etc. under the regulations would still apply even after the MDL expired. Non-repair parts such as accessories and consumables may require an MDL.

What is not clear to me is the requirement to maintain ISO13485 for post-end of sales servicing in these cases. Potentailly a gap in the regulation, but not the first one that's been raised. I would think the manufacturer would want to keep the "certified" servicing processes in place as a matter of due dilligence if nothing else.

I'd be interested if there were other perspectives on this approach.
 
 
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