CMDCAS versus ISO 13485 - What are the additional requirements

B

Bill Goss

#1
Can anyone explain the difference between CMDCAS and ISO 13485? I'd like to know what additional requirements are in CMDCAS that are over and above the requirements of ISO 13485. Thanks.
 
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R

Roland Cooke

#4
I always recommend to my clients that they create a CMDR-specific SOP, detailing how each and every one of the regulations has been addressed, either within an existing (tweaked) SOP, or within this 'master' SOP.

No it's not a requirement to do that, but IME it's simply too easy to miss something.
 

DannyK

Trusted Information Resource
#6
But can you tell me what CMDCAS requires that ISO 13485 does not require?
Some of the requirements that need to be documented are:
1. Mandatory problem reporting: who to contact and when
2. Recall process
3. Specific requirements for the scope of registration
4. Technical file requirements
5. Licensing process
6. Labeling requirements
7. Distribution records
8. Advisory notices

There are other topics that have to be addressed as well.

I hope this helps.
 
B

Bigdubz

#7
My understanding of it is that there are no additional requirements per se, but you need to have your 13485 QMS audited by an accredited CMDCAS Notified Body.

Also, I noticed recently that Health Canada are looking towards a mutual recognition with Australia. So if you have product registered in Aus, it should be easier to do so in Canada, after your CMDCAS success.
 
R

Roland Cooke

#8
My understanding of it is that there are no additional requirements per se,
Not correct. There are specific requirements within the CMDR, much as there are specific requirements within the MDD.

but you need to have your 13485 QMS audited by an accredited CMDCAS Notified Body.
True, and actually it's even stricter than that - the (lead) auditor has to have been individually approved by Health Canada.

Also, I noticed recently that Health Canada are looking towards a mutual recognition with Australia. So if you have product registered in Aus, it should be easier to do so in Canada, after your CMDCAS success.
Indeed
 
Q

QMLady

#9
Hi there. I am working in the medical device industry. I have to find out about the additional requirements of CMDCAS compared with ISO 13485. As far as I know there have been changes in Canada in 2011. Does anybody has a GAP Analysis comparing CMDCAS with ISO 13485 and does anybody know what has changed exactly last year? Thank you. :)
 

DannyK

Trusted Information Resource
#10
I would recommend you to obtain a copy of GD210 aand it provides a good iidea of the questions that could be asked.
GD210 can be obtained from the Health Canada website. Do a search on google and you will find it.
 
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