Requirements for selling Class I Medical Devices in Canada

S

Slaterson22

Re: Medical Devices in Canada

You do not need a 13485 for Canada when dealing with a class l medical device.

You need to submit a MDEL (medical device establishment license)
 
M

medi12

Re: Medical Devices in Canada

Exception: You don't need an MDEL if you sell your products solely via a licensed distributor.
 
2

20130523

Help me out here, I have a question... What if you are a class II device, and you have both medical (class II) and non medical devices, and you are only a distrubotr... Distributor submits an app for an MDEL... what happens next? Is this the way it is supposed to work?
 

DannyK

Trusted Information Resource
Help me out here, I have a question... What if you are a class II device, and you have both medical (class II) and non medical devices, and you are only a distrubotr... Distributor submits an app for an MDEL... what happens next? Is this the way it is supposed to work?

After the application is accepted, you receive a license and you can sell the class of devices and the products that are on the application. You will receive an annual renewal to update the list of manufacturers. Health Canada may send an inspector to verify if your procedures conform to their guidance requirements and will also check if you are selling unlicensed devices in Canada.
 

Rupali

Registered
After the application is accepted, you receive a license and you can sell the class of devices and the products that are on the application. You will receive an annual renewal to update the list of manufacturers. Health Canada may send an inspector to verify if your procedures conform to their guidance requirements and will also check if you are selling unlicensed devices in Canada.
What happens in the case where you are distributing for many manufacturers..ie 10 different manufacturer of gloves?
 

Rupali

Registered
After the application is accepted, you receive a license and you can sell the class of devices and the products that are on the application. You will receive an annual renewal to update the list of manufacturers. Health Canada may send an inspector to verify if your procedures conform to their guidance requirements and will also check if you are selling unlicensed devices in Canada.
Also just a few questions, if you don't mind..Can I go ahead and apply or do I need to make sure these written procedures are already in place?..also I am assuming you can't begin selling?, curious as I just became aware of the MDEL and started selling already, didnt even know what MDEL was, will this implicate things?..ls there any templates or guidelines on what the procedures should entail, kind of lost when it comes to prepping this, anything on Google we can use to prepare these?
 

DannyK

Trusted Information Resource
Theoretically you should not be selling until you have the procedures because in your MDEL application, you are attesting that the procedures are in place.
There are guidance documents by Health Canada for recall, mandatory problem reporting, etc....
Read the guidance document and it should help you out.
 
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