CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audits?

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RSantos

Registered Visitor
#12
I just got through with a CMDCAS/13485 audit successfully. In the 13485 based procedures, I had included the Health Canada requirements in the procedures titled:
Risk Assessment
Medical Device Reporting/Vigilance System
Obtaining a CE Mark
Management Responsibilities

The manual scope states that the quality system meets the requirements of Canada's Schedule No. 1101
 
R

rose24m03

#13
Canadian guidance

per Canada, guidance may remain at draft state for some time. regardless, they expect you to follow it, draft or no draft.
 
J

jewels

#14
Non-CMDCAS registered Notified Bodies

Comment to Cathy in Northern Ireland---

When we chose our registrar, we made sure that they would be CMDCAS registered. If your registrar is not CMDCAS registered and you would need to have another registrar come in to do another audit just for Canada----that's a shame. Maybe you could request your auditor to register in Canada---or get a new registrar?
 
C

cel1ne

#16
Re: CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audi

My company is selling medical devices to Canada. We are going to move site in august and we are having an audit on wednesday for renew of our certification ( including CMDCAS) . Apparently, the auditor said that the move will have a big impact on our CMDCAS and licenses.

Can anyone help me with that? :confused:
i cant find any informations about that?

Thanks
 
R

Roland Cooke

#17
Re: CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audi

Your post was a little confusing.

As far as I could make out, your company already holds an SCC-accredited ISO13485 certified, issued under CMDCAS.

You will be changing locations in August.


I think the first thing to say is that your move in August shouldn't really impact your audit this week, except maybe to show control of the upcoming change via management review, risk management plans etc etc.


You are required to advise your registrar of significant changes, in advance, and it is sensible to give them at least three months notice, which you appear to have done. Note that a quick phonechat with your auditor is not necessarily the same thing as formal notification, best to follow that up with a fax or email directly to the registrar.

There will need to be a re-audit of the new facility at some point, you should discuss those logistics with your registrar. You will receive a new ISO13485 (SCC) certificate from the registrar, this will need to be copied to Health Canada within 30 days.

You will need amended device / establishment licenses from Health Canada, the F201/202 forms can be found on their website. I've forgotten the timing on that, I'm sure someone can remind me.
 
Z

zolakeene

#19
Re: CMDCAS vs. ISO13485 - Additional requirements to normal ISO 13485 for CMDCAS audi

Hi Is there a document available which identifies the Canadian Medical Device classifications?

Thanks
 
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