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

H

Hanson

#1
Hi

Can anyone have idea about the additional requriements to normal ISO 13485 for CMDCAS audits? Thanks.
 
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C

Cathy

#2
Hi Hanson,

I am in much the same position as you right now. I have checked health canada website and found this guidance document.

Basically, all they have done is built product certification into ISO13485. I am having bother understanding the whole thing. ISO13485 stands with ISO9001:1994 as a QUALITY SYSTEM. To be able to sell in Canada you need IOS13485 with a certificate issued from a CMDCAS approved auditor. Now my problem is ISO13485 is an international std and should not and cannot have its requirements added to by government authority. Maybe i have this wrong and please correct me if this is so because I am refusing to renew our licience in canada.

In Europe we CE mark our product. this is our product certification and while ISO13485 helps us to achieve conformity to these regulations we still keep the actual product certification seperate.

I have talked to our registrar and it will cost us about £3,000 to have an auditional audit carried out to ensure it is carried out by someone CMDCAS approved!! and belive me for what we sell this is not worth the hassle.


Please help if you can!!

Cathy
 

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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#3
Hanson said:
Hi

Can anyone have idea about the additional requriements to normal ISO 13485 for CMDCAS audits? Thanks.
There is a Canadian version of 13485, but Canada will recognize registration to ISO 13485 if it is with a registrar approved by Canada.

We registered to the Canadian requirements in January. They wanted to see reference to the Canadian MDR in the manual and procedures. This was to include:

  1. Complaint Handling
  2. Mandatory Problem Reporting
  3. Recalls

See sections 57-65 in the Canadian MDR. It tells you what you are required to do. Revise your procedures to add their requirements and reference the Canadian Minister.

I've attached the regulation and a guidance document you might find usefull.

There are more Guidance Documents at
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/medical_devices_e.html
 

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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#5
jonathan said:
Can any body provide the instructions related to ISO 13485:2003 for CMDCAS audits?
Your question is a little vague. Can you be more specific? What instructions? What requirement? The more specific, the better we will be able to provide information and answers.
 

amjadrana

Involved - Posts
#6
CMDCAS vs ISO 13485

Yes, I agree with Al Rosen. The same standard ISO 13485:2003 will be audited by a registrar that is approved by Health Canada. The registrar will audit the technical file prepared according to the Canadian Medical Device regulation. The certificate will also mention CMDCAS registration. This certificate is required, when a manufacturer wants to sell products in Canada.
 
J

jonathan

#7
OK, thanks you both. My company have got the Certificate to sell products in Canada. Now we will update the quality system from ISO 13485:1996 to ISO 13485:2003. At the same time, we want to combine CMDR to our quality system. So I need some instructions, such as CMDCAS guidance, or the analysis list including the special requirements from CMDR.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#8
jonathan said:
OK, thanks you both. My company have got the Certificate to sell products in Canada. Now we will update the quality system from ISO 13485:1996 to ISO 13485:2003. At the same time, we want to combine CMDR to our quality system. So I need some instructions, such as CMDCAS guidance, or the analysis list including the special requirements from CMDR.
The Guidance Documents you need are already posted in or linked to this thread.
 
J

jonathan

#9
Yes, I saw a guidance linked. But that one was for ISO 13485:2003. I want to know whether the new guidance has been drafted or not. Or any other kinds of instructions can be useful?
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#10
jonathan said:
Yes, I saw a guidance linked. But that one was for ISO 13485:2003. I want to know whether the new guidance has been drafted or not. Or any other kinds of instructions can be useful?
Follow the link in post #3 to the Canadian Medical Devices web site. You will find the most recent guidance there.
 
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