Procedure Packs / Conveniance Kits Registrations - Canada

F

Fredde

We have a number of products registered in Canada. The market has newly enquired if it would be possible to provide some type of “starter” kits or similar with an assortment of products for the patient to try. Products already approved and being both Class I and Class II.

In US our subsidiary has a repacker license allowing them to repack already approved products into Convenience Kits.
1. Is there any similar regulation in Canada?
2. Does our registered importer in Canada have to do this repacking, or could we register and import Conveniance Kits from US?
If so, what would be the procedure for this?

If you could point me to relevant guidance in this matter it would be great.
I have asked Health Canada, but they do not seem to respond.

Thank you for your help.
 

Marc

Fully vaccinated are you?
Leader
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 
Y

yana prus

Hi Fredde,

You can register your kits as a medical device group family.
A medical device group family:
Means a collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. Examples might include: IV administration sets, dressing trays, contact lens care kits or irrigation trays.
Further information can be found here:
Guidance Document - How to Complete the Application for a New Medical Device Licence - Canada.ca

I'm attaching the link to the example of registration of such a kit:
http ://webprod5. hc-sc. gc. ca/mdll-limh/information.do?deviceId_idInstrument=230800&deviceName_nomInstrument=100CC+SILICONE+EVACUATOR+KIT+WITH+HUBLESS+SILICONE+FLAT+DRAIN&licenceId=14713&lang=eng - DEAD LINK UNLINKED (404)

Regarding your second question - it depends on the product class: the registration path will be slightly different for class I and class II device.
 
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