Requirements for selling Class I Medical Devices in Canada

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S

Slaterson22

#2
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

#3
Re: Medical Devices in Canada

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

20130523

#4
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
#5
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.
 
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