Labeling - New company address

Karichan

Starting to get Involved
#1
May anyone give me an idea.

Our company holds a MDL and was just relocated. We have notified Health Canada of the change of address and we scheduled for an ISO 13485:2016 conversion audit in May.

We need an updated ISO 13485 cert for supporting our application for the change of MDL.

So, should I use the updated labeling (address changed only) right now? or we should wait until the issuance of ISO 13485:2016 cert? or finally the issuance of the updated MDL? (but it may take about 3 months later)

Thanks in advance
 
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mihzago

Trusted Information Resource
#2
you should probably wait for the updated ISO cert before you start using the new address on the application, HC will ask about the new address and whether you submitted an address change application.
 

shimonv

Trusted Information Resource
#3
May anyone give me an idea.

So, should I use the updated labeling (address changed only) right now? or we should wait until the issuance of ISO 13485:2016 cert? or finally the issuance of the updated MDL? (but it may take about 3 months later)

Thanks in advance
Hi Karichan,
From experience HC will not accept your license update request before you have an updated ISO certificate.

As for your question about when to start using the updated labeling, I am not aware of any written guidance or requirement about it. Fortunately it's not a big deal either way. My personal inclination is to update the labeling right now and continue with marketing, and once you have all the formal docs update MDL accordingly.

Shimon
 

RA Guy

Involved In Discussions
#4
Hi Karichan

Not sure if you are aware, but this is the form with instructions for new manufacturer address:

Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only - Canada.ca

As you can see the updated certificate is required to facilitate the change and there are additional requirements beyond the revised certificate.

My interpretation regarding the labels is the they should not be changed until Health Canada acknowledges/approves the change in writing in response to your amendment application. Otherwise it is not aligned with the current MDL and therfore out of compliance with the regulations.

The CMDR label requirement is:

Labelling Requirements
21 (1) No person shall import or sell a medical device
unless the device has a label that sets out the following
information:
(a) the name of the device;
(b) the name and address of the manufacturer;

Good luck.
 
#5
Hi Karichan,

I went through this (edit: by "this" - i mean we actually did a company name change) last year at this time and would strongly suggest you drop them an email letting them know what you're planning to do. We did this and they got on a phone call with us and were extremely helpful. Friendly and helpful.

IIRC, we did have our updated certificate in hand and included it with the fax-back form (which they had us scan and email instead of fax - very convenient and a tiny cost savings).

Not sure whether your are importing yourself or have distributors. We had to assist some of our distributors as well.

Our amended licenses were issued within 24 hours of providing them the fax-back form. Not sure you will get that turnaround time but they were really great.

Let me know if I can provide more information, as I can go back in the file and correspondence and let you know.

Additional EDIT re: labeling - we had no problem with labeling and just provided our "shippers" (all relevant folks) with a copy of the old license and the amended license. I can't say definitively that there were no hiccups but we didn't hear of anything. I would wait until the license amendment is approved before updating labeling but anything on the water should be fine.

EDIT3: and don't forget to notify your regulatory correspondent and amend your agreement with them to reflect the change.

Best,

supadrai
 
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