Performing Internal Audits as per Canada MDR GD 210

sreenu927

Quite Involved in Discussions
#1
Hi All,

I noticed the following in GD 210 of Health Canada Guidance Document:

2.3.3 Nonconformities​
All nonconformities shall be reported directly against a requirement of ISO 13485:2003 and​
never directly against a section of the MDR.

So this means, while performing Internal Quality audit, we should not mention the MDR requirements are NOT met. We should only reference the ISO 13485 Clauses.

Would anyone confirm the above?

Thanks,
Sreenu
 
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A

arios

#2
GD 210 is a guidance document for registrars (That means, Notified Bodies, e.g. TUV, BSI, KEMA, etc), so that requirement is not applicable for you, if your organization is not a registrar.

Annex A of GD 210 provides a cross reference, so if the registrar finds a non-conformity related to a SOR 98-282 section (Also known as CMDR or MDR=Medical Device Regulation) that finding can be linked to the applicable ISO 13485 clause, because in essence that is what the issue is.

For internal audit purposes I don't see a restriction for raising non-conformances vs. the CMDR, however it is good to remember that ISO 13485 is designed to allow adoption of other Medical device regulations into your QMS, so ISO 13485 continues to be the platform of your system even if other regs are involved. Still GD 210 is a very good guidance document which you can use to facilitate your internal audit questions.

I hope this helps :2cents:
 
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DannyK

Trusted Information Resource
#3
Arios is right.

There is no problem for you to reference the CMDR clause for your internal audit. If you show that you write findings to the CMDR, it demonstrates that you used it for your internal audits.
Because GD210 is a guidance document, you cannot write up a finding versus this document.
 
D

DrM2u

#4
That is exactly what it says!

OK, let me elaborate: MDR is the equivalent of FDA in Canada. However, CMDR is now more of an interpretation and a guide manual of ISO 13485 for implementation in Canada. I found the manual very useful even in the US. Therefore, as they indicated, any findings should be written against ISO 13485. FDA thinks that they are a little hollier and therefore entitled to have their own 'standard'.

Here is an excerpt from Health Canada:

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003.
 
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sreenu927

Quite Involved in Discussions
#5
Dear Arios, Danny and DrM2U,

Thanks for all your expertise and clarification.:)

Just to share with our fellow covers, as part of our upcoming Audit by CMDCAS auditors, I propose to do the following additional things to the current ISO 13485 requirements:
1. Include CMDR requirements in the scope of quality manual
2. Management review meeting minutes-objective evidence to show that CMDR regulatory requirements were discussed
3. Medical Problem reporting or MDR or AE reporting timelines as per CMDR
4. Recall procedure updated per CMDR sections
5. Internal auditors to be trained on CMDR
6. Perform Internal audit as per CMDR
7. for high risk (Class III, IV) devices, "Significant changes reporting to authority" procedure should be in place
8. Distribution records to be maintained and also at importer side

Any comments?

Thanks,
Sreenu
 
A

arios

#6
Dear Arios, Danny and DrM2U,

Thanks for all your expertise and clarification.:)

Just to share with our fellow covers, as part of our upcoming Audit by CMDCAS auditors, I propose to do the following additional things to the current ISO 13485 requirements:
1. Include CMDR requirements in the scope of quality manual
2. Management review meeting minutes-objective evidence to show that CMDR regulatory requirements were discussed
3. Medical Problem reporting or MDR or AE reporting timelines as per CMDR
4. Recall procedure updated per CMDR sections
5. Internal auditors to be trained on CMDR
6. Perform Internal audit as per CMDR
7. for high risk (Class III, IV) devices, "Significant changes reporting to authority" procedure should be in place
8. Distribution records to be maintained and also at importer side

Any comments?

Thanks,
Sreenu
You have a good list, nice job! :agree1:

Would also invite you to clarify who is responsible for compliance with the CMDR, that could be part of your Job description if you are the management rep.
Also include in your records retention policy a reference to the retention of the Canadian licences. At this time you may not have any license yet, but you should identify them as records in your system.
Also it is good to remember that before November 1st of each year you have other obligations to inform (Take a look on section 43 of the CMDR). That includes when you made no changes.
 

sreenu927

Quite Involved in Discussions
#8
Hi Arios,

Thank you!

1.
"Would also invite you to clarify who is responsible for compliance with the CMDR, that could be part of your Job description if you are the management rep."

Sorry, I didn't understand the below. Could u pls elaborate?

Generally, the resp to maintain the quality system will be by every empolyee as per written SOPs, WIs and Quality Manual, right! For auditors, the contact point will be the MR.

2. So all (product) licenses must be kept as quality records?? does it includes the ISO certificates as well?
3. Yeah, I'l go thru again on section 43.

Thanks&Regards
Sreenu
 
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