Hi

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

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

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:


Complaint Handling
Mandatory Problem Reporting
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

Can any body provide the instructions related to ISO 13485:2003 for CMDCAS audits?

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.

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.

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.

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.

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?

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.

Al Rosen, Thanks very much. I got it.

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

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

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?

http://www.scc.ca/en/programs/iso_reg/accredited_clients_cmdcas.shtml

This lists the Qualified Registration Bodies (CMDCAS). Note: One of the ones on this list has had their scope suspended.

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

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.

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/signchng_modimportante_v3-eng.pdf