Canada - Essential Requirements Checklist for MDD 93/42/EEC

Sue789

Involved In Discussions
#1
Hi All,

My mind has gone blank!

I have an Essential Requirements checklist for 93/42/EEC and need to add the additional requirements for Canada.

Can anybody point me the right direction or do you have an example for a Canadian Essential Requirements checklist?

I am up against it as we have our first CAMDCAS audit on Monday!!!!
Sue
 
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DannyK

Trusted Information Resource
#2
Re: Canada - Essential Requirements Checklist

There is no essential requirements checklist. You have to ensure that your system meets the Canadian Medical Device Regulations. Your documentation should address the Canadian requirements. You can refer to GD210 on the Health Canada website. I have helped my clients by providing them with a procedure that addresses the majority of requirements.
 
B

blmuskrat

#3
Re: Canada - Essential Requirements Checklist

Willing to share that procedure once again? Thanks.
 

Mark Meer

Trusted Information Resource
#4
I believe that CMDCAS is most similar to ISO13485, with the addition of some Canadian-specific adverse-event reporting and recall procedures...

I can't post a link to a thread because my post count is too low. :(

But search the forums here for a thread with postid=61342
(or search CMDCAS + ISO13485)
 
#8
The following are what I am using for my medical devices iCanada:
GHTF/SG1/N68:2012
GHTF/SG1/N70:2011

Using this, a checklist very similar to the European one can be created. Australia also has a similar list.
 

Salisburysteve

Starting to get Involved
#9
From memory:

Include Health Canada in your authorities to notify of Adverse incidents/problem reporting/advisories/recalls. Required for incidents not in Canada.
Consideration of HC requirements in change control/design control.
Ensure staff have the training and awareness to conduct their tasks such that HC quality requirements are fulfilled.
Notify HC Minister should you wish to cease licensing your device.
Notify HC of any certification renewals within 30 days
Responsibility of complying with CMDR/GD210
HC device classification & current licenses. License changes.
Distributor agreement and records (e.g. complaints procedures)

Regards,

Steve
Odstock Medical Ltd
 
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