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Requirements for selling Class I Medical Devices in Canada
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Requirements for selling Class I Medical Devices in Canada
Requirements for selling Class I Medical Devices in Canada
Requirements for selling Class I Medical Devices in Canada
Requirements for selling Class I Medical Devices in Canada
Requirements for selling Class I Medical Devices in Canada
Requirements for selling Class I Medical Devices in Canada
Requirements for selling Class I Medical Devices in Canada
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Requirements for selling Class I Medical Devices in Canada


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Some Related Topic Tags
canada, class i medical device, cmdcas certification, iso 13485 - medical device qms, mdel (medical device establishment license), cmdcas (canadian med device conformity assmnt system)
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  Post Number #1  
Old 22nd April 2011, 02:59 PM
ISO 13485 - Medical

 
 
Total Posts: 60
Please Help! Requirements for selling Class I Medical Devices in Canada

Can somebody confirm if you need to have ISO 13485 including CMDCAS in place to sell class 1 medical devices in Canada?

Many thanks

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  Post Number #2  
Old 22nd April 2011, 03:47 PM
Slaterson22

 
 
Total Posts: 8
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)
Thanks to Slaterson22 for your informative Post and/or Attachment!
  Post Number #3  
Old 6th May 2011, 03:12 AM
medi12

 
 
Total Posts: 9
Re: Medical Devices in Canada

Exception: You don't need an MDEL if you sell your products solely via a licensed distributor.
  Post Number #4  
Old 14th September 2012, 02:19 PM
20130523

 
 
Total Posts: 42
Re: Requirements for selling Class I Medical Devices in Canada

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?
  Post Number #5  
Old 14th September 2012, 05:31 PM
DannyK

 
 
Total Posts: 673
Re: Requirements for selling Class I Medical Devices in Canada

Quote:
In Reply to Parent Post by Ambir 775 View Post

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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