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Canadian Registration (Health Canada) - Establishment vs. Device

Q

QM Becky

#1
Hi Folks,
I've got a conundrum... need some information to make a good decision.

I've scoured the Health Canada site, and feel pretty knowledgeable right now. here's the situation:

We've recently initiated the acquisition of a smaller device company. During the transition from "them" to "us" they continue to manufacture under their own certifications, licenses etc and we are simply a distributor. Once our validation work is complete, we will take on manufacturing and will cease to distribute for them, and they will cease to exist.

Here's my issue: I need to sell a few of the products in Canada. I understand that in order to do that I need a device license and/or an establishment license. During the initial phase, we would need an establishment license to distribute and "them" would need to have licenses. Once we manufacture, we need to apply for our own licenses to sell under.

My concern is the time frame... I can't find any good guidance on the timelines for either of these 2 processes. I don’t want to bother with the establishment license if it will take long enough that I’m going to turn around and apply for the device license. On the flip side, I don't want to miss out on sales opportunities either.

So, 2 questions:
1) Can anyone give me some general timeline guidance on the device and establishment licensing processes in HC?
2) Does anyone know if it is possible to apply for my device licenses in anticipation of the time when we manufacture? (so that I can save time trying to bring these to market under our own licenses).

Hope those make sense... any/all input is appreciated.

-Becky
 
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M

MIREGMGR

#2
Re: Canadian Registration - Establishment vs. Device

1) Can anyone give me some general timeline guidance on the device and establishment licensing processes in HC?
Last year, HC sent out annual establishment renewal applications dated August 1 with a September 1 due date, and they didn't get them all processed by January 1. So, this year they sent out the renewal applications dated July 1 with an August 1 due date, and a warning that if that due date is missed, issuance of the renewal will be delayed.

And, we work with a vendor that has been trying to get them to sort out some simple changes to device licenses for over six months.

For both license types, I'd say six months or longer.
 

DannyK

Trusted Information Resource
#3
Re: Canadian Registration - Establishment vs. Device

Having an overlap is the safest way to deal with Health Canada. Do not forget that in order to get the Health Canada license you need an ISO 13485 certificate from an approved registrar (CMDCAS). It may take time to get the ISO 13485 certificate.
 
Q

QM Becky

#4
Re: Canadian Registration - Establishment vs. Device

Having an overlap is the safest way to deal with Health Canada. Do not forget that in order to get the Health Canada license you need an ISO 13485 certificate from an approved registrar (CMDCAS). It may take time to get the ISO 13485 certificate.
Apologies for not including that information, Danny, you are correct & we do have our ISO 13485 certificate.

Anyone have any ideas about trying to register a product that isn't technically ours yet, but will be and having the registration reflect the time delay? I want to be able to sell immediately, and not have to wait to start the 6 month (give or take) clock when the products are fully ours.

Thanks!
 
Last edited by a moderator:
C

Citizen Kane

#5
Since your company is not yet transefered to your structure - so not officialy yours (as you said, still their production and certificates), you should be able to sell them as a distributor. But this is possible if they have the product registered on their side. And, if so, since you now have one management structure and executive, internally, should be no issue.
 
C

CBAL08

#6
IS there a special form for applying for Medicald evice license in Health Canada? IF there is where would I find it? Pelase help.

Do we need to have a speical format for the application? ( FDA has a clear format)

We want to apply the MDL for software (Class II) and therefore do we apply individually as per the latest version? Suggestions are highly appreciated?

Please help as I cannot find much help in the HC site.
 
M

MIREGMGR

#7
Re: Canadian Registration - Establishment vs. Device

Last year, HC sent out annual establishment renewal applications dated August 1 with a September 1 due date, and they didn't get them all processed by January 1. So, this year they sent out the renewal applications dated July 1 with an August 1 due date, and a warning that if that due date is missed, issuance of the renewal will be delayed.

And, we work with a vendor that has been trying to get them to sort out some simple changes to device licenses for over six months.

For both license types, I'd say six months or longer.
As a follow-on to my earlier post: I was involved with two establishment license renewals for 2011. Both should have been regular and uneventful. Both applications were filed promptly (i.e. July) after the forms were sent out. HC processed one before 2011 began, but the other one still isn't processed. I've had multiple contacts with them, and their response is to direct me to be patient.

So, my earlier "six months" advice is now revised to "seven months or longer".
 
Q

QM Becky

#8
Re: Canadian Registration - Establishment vs. Device

Wow, I'm sorry it's taking so long for you. We ended up submitting all of our license applications a few months ago and it took literally 14 days to receive our licenses. In one instance some additional information was needed, so the 14 day clock was restarted. I was able to find information on the HC site that indicated that they aim to fill requests within 14 days. I also learned that the woman who works on these licenses (at least for our class/product type) only works on Monday and Wednesday so that helped to understand the waiting game.
I hope your process clears up soon!
-B
 
C

CBAL08

#9
Re: Canadian Registration - Establishment vs. Device

Wow, I'm sorry it's taking so long for you. We ended up submitting all of our license applications a few months ago and it took literally 14 days to receive our licenses. In one instance some additional information was needed, so the 14 day clock was restarted. I was able to find information on the HC site that indicated that they aim to fill requests within 14 days. I also learned that the woman who works on these licenses (at least for our class/product type) only works on Monday and Wednesday so that helped to understand the waiting game.
I hope your process clears up soon!
-B
Hi was reading your post and found that you did apply for device licenses. Knowing that you al have had experience with device licencing I was wondering if you could have some suggestions for us. Does the application have to be in certain format? Do they have some kind of form or do we compile everything in a document and submit like 510 ks? Please help.
 
Q

QM Becky

#10
Re: Canadian Registration - Establishment vs. Device

Hi was reading your post and found that you did apply for device licenses. Knowing that you al have had experience with device licencing I was wondering if you could have some suggestions for us. Does the application have to be in certain format? Do they have some kind of form or do we compile everything in a document and submit like 510 ks? Please help.
Good Day,
The application process in Canada was actually quite simple (compared to other countries). The linke below is to the Health Canada Site for Medical Devices. On the left hand side you will see a link to "Application Information". Once there, click on "Forms" and you will find a list of forms that are to be completed for your license application. There is no requirement for a device license for Class I devices, but if that's all you have, you will likely need an establishement license to be able to sell them. Class II, III and IV devices need a license. There is a separate form for each. It's important to note, (I got caught on this one) that if you are licensing a "family" of devices they must be made of the same materials and only differ in size or quantity etc. I have a family of vessel cannulas that to our company is a family of products, however, some are PVC, and some are polycarbonate. I tried to license them together, but they are actually 2 different "families" for Canadian licensing purposes. I had to resubmit.
I recommend that you become familiar with the Guidance Document (How to Complete the Application for New Device License) that I've linked below as well. It goes into much more detail.

Also, Health Canada was extremely helpful in answering any questions I had regarding payment, submission and follow up. They are a great resource. As I am in the US and not a Canadian expert, I can only give you advice based on my experience. The Health Canada web site has a TON of information and once you delve into it, it is actually quite easy to follow.

I hope this helps. I've added the 2 links I talked about below. Please feel free to keep the questions coming! Good Luck!

Health Canada: Medical Devices Site
http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php

Guidance Document: How to Complete the Application for New Device License
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php
 
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