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MDEL Process

#1
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?
 
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mihzago

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#2
Submit MDEL application as soon as you can and develop the required procedures.
This guidance document Guide to Recall of Medical Devices (GUI-0054) - Canada.ca provides a really good overview of what should be in the procedure for recalls. You could probably adapt it to make it your procedure.

for the distribution and complaint handling, there may be some generic procedures available through 'google', but it may be better to find a regulatory professional who can develop or at least modify them so they're applicable to your company.
 
#3
Great Thank you for your help, I just didn't know of I should have these in place first or if they give us time after submitting the application
 

mihzago

Trusted Information Resource
#4
well, you certify on the MDEL application that you have these things in place and while they normally don't verify this, there is some risk if you sell products without having these procedures.
 
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