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The process for Canadian Marketing of Class II, III, and IV Medical Device

C

CBAL08

#1
The Canadian Medical Device License (MDL) is required for companies which sell Class II, III, and IV medical devices in Canada.
When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485:2003 quality system ( We already are) that ALSO meets the specific requirements of the Canadian Medical Device Regulations (CMDR) ( planning to have this as well).
When we read this the actual process is to first have registration for ISO 13485 + CMCDAs....in order to have the certificate we should have the MDRs Mandatory requirements and the SOPs to fulfill those requurements...however what I do not understand is is the Marketing representative or tyhe distributor selected after being certified ? or do we need to have the License and the marketing represenative before being ceritified??? Please clarify on this or would be great if someone could provide a flow chart on the exact process of marketing Medical device in Canada....
 
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R

rclanzillotto

#2
Re: Canadian Market for Medical Device

ISO 13485 + CMDCAS first. As part of the audit they will look for SOP's that address the CMDR. You can become certified (ISO 13485 + CMDCAS) and licensed prior to having a distributor in place.

Recommend you call them...Health Canada is very helpful for the most part. They also have a licensing guidance document.

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DannyK

Trusted Information Resource
#3
Re: Canadian Market for Medical Device

Hello CBAL08,

There is no specific requirement for a marketing representative for selling into Canada.
You can sell direct to Canadian customers, if you wish.
In order to sell legally into Canada, you need a Health Canada license. Before you get a license , you need to be audited by a CMDCAS approved registrar for ISO 13485 + CMDR Requirements.
To find out exactly what is required, I would recommend you google 'GD210", that provides a guideline to auditors on how they should audit the Canadian requirements.

I hope this helps!
 
C

CBAL08

#4
Re: Canadian Market for Medical Device

Thank you for your suggestion.
As we are planning to have the CMDR audit in late November, will try my best to have the SOPS ready by then. As said we already have the documents for ISO and FDA requirements...we will just need to add some essential SOPs.:thanx:
 
R

Roland Cooke

#5
I advise all my clients to create a top-level SOP for Canadian compliance. This addresses each element of the CMDR line-by-line, cross-referencing to existing procedures where appropriate, giving specific instructions if no existing SOPs already cover particular elements.

No, it's not a requirement to have such an SOP, but my experience is that it saves a lot of pain. (The SOP 'guarantees' that you address all of the CMDR elements, and just as importantly it provides good transparency to your auditor that you have addressed all the elements.)
 
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