Adding a Class I to a sample box

D

dr1vn

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#1
#1
We're putting together a sample box of some products. These include an OTC Class II medical device and various consumer products that we also sell on their own. We're planning on adding some band-aids which are Class I in the US and Canada. The band-aids are being obtained from a supplier and we're just adding them to this sample box as a sort of give-away and fun thing to add into the box when consumers order the product on-line.

My question is do we need to register the Class I with Health Canada? We already have an MDALL for the Class II, but with the addition of the Class I, I'm not sure what we need to take of with Health Canada. And, do we have to update our 13485 certificate as we are adding a Class I as a give-away in our sample boxes? Would our Notified Body need to be made aware now that we are adding a Class I?
 
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RA_QA_Expert

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#2
#2
Hi, all class I medical devices are exempt from licensing process with Health Canada incl. QMS requirements.
NB is involved only for EU, that means you don't have to report it.
 
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D

DannyK

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#3
#3
dr1vn said:
We're putting together a sample box of some products. These include an OTC Class II medical device and various consumer products that we also sell on their own. We're planning on adding some band-aids which are Class I in the US and Canada. The band-aids are being obtained from a supplier and we're just adding them to this sample box as a sort of give-away and fun thing to add into the box when consumers order the product on-line.

My question is do we need to register the Class I with Health Canada? We already have an MDALL for the Class II, but with the addition of the Class I, I'm not sure what we need to take of with Health Canada. And, do we have to update our 13485 certificate as we are adding a Class I as a give-away in our sample boxes? Would our Notified Body need to be made aware now that we are adding a Class I?
Click to expand...
If you are distributing the sample boxes directly to the consumer, you are exempt from requiring an MDEL.

I would encourage you to look at the requirements here. Guidance on Medical Device Establishment Licensing (GUI-0016) - Canada.ca

To reply to RA_QA Expert.
For Canada
Manufacturers of Class I medical devices who import or distribute their own devices require a Medical Device Establishment License.
Check out the link above that provides the requirements.
 
D

dr1vn

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#4
#4
Thanks for the replies. Reading through the guidance I think the key point is under the "Establishment licence exemptions" where it includes , "
Manufacturers of Class II, III or IV medical devices* that sell:
  • Medical devices for which they hold a valid medical device licence."
Since we have an MDL an MDEL is not necessary. We just go ahead and start adding bandages to the sample boxes.
 
D

DannyK

Trusted Information Resource
#5
#5
dr1vn said:
Thanks for the replies. Reading through the guidance I think the key point is under the "Establishment licence exemptions" where it includes , "
Manufacturers of Class II, III or IV medical devices* that sell:
  • Medical devices for which they hold a valid medical device licence."
Since we have an MDL an MDEL is not necessary. We just go ahead and start adding bandages to the sample boxes.
Click to expand...
You have to be careful.
Are the band-aids part of the kit that was licensed ?
If you distribute the band aids to another distributor in Canada and it is not part of the kit, then you would require an MDEL even though you have an MDL.
 
D

dr1vn

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#6
#6
DannyK said:
You have to be careful..
Click to expand...
That's the quote that keeps me up at night! There's many methods for selling and distributing product and it always surprises me what our sales department will come up with. That being said, I *think* our method avoids the MDEL requirement as we are selling the box direct to a consumer.
 
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