Canada Importer Record Retention Requirements - Disagreement with NB auditor

[Arnthor]

Dear all,

The story go this way:

My Firm (manufacturer) sold to Company A in US, Company A sold to Company B in Canada (Canada importer).

My firm had QA agreement with Company A.

Company A had QA agreement with Company B.

All communication with company B had to go thru company A.

My firm recently had a re-certification audit and one of the auditor had fault my firm for no evidence to show that my Canada importer complied with retention record requirement.

Does my firm had to ensure my Canada importer complied with Canadian Medical Devices Regulations? I thought it was the Canada importer own responsbilities?

Can I disagree with the auditor findings?

Please advice.

Arnthor

 

[harry]

Re: Disagreement with NB auditor

................................ My firm recently had a re-certification audit and one of the auditor had fault my firm for no evidence to show that my Canada importer complied with retention record requirement. .......................................

If you think you are right, you can appeal. Check your agreement with your NB. There are usually provisions in it to resolve this kind of problem. Generally, you go to the next level - the Certification Manager with an appeal.

 

[somashekar]

Re: Disagreement with NB auditor

Can I disagree with the auditor findings?

No Sir...
At 55. of the part 1 of MDR
The manufacturer, importer, and distributor shall retain the distribution record maintained in respect of a device for the longer of :
(a) The projected useful life of the device, and
(b) two years after the date the device is shipped
At 56.
Distribution records shall be maintained in a manner that will allow their timely retrieval.
Does both the agreements cover this ? Is it in practice ? Seems no ~~~~

 

[Qara123]

My Firm (manufacturer) sold to Company A in US, Company A sold to Company B in Canada (Canada importer).

Who holds the Canada License for your product? Your firm, Company A or Company B?

If your firm is not the license holder, I think you can justify that "your Canadian Importer" is not really yours and what Company A does with your product after it is legally purchased is "none of my business" (even though it is your business ... oh no...the Friday bug is back...).

Q

 

[DannyK]

If in your agreement with Company A, you had a provision that all requirements had to be flowed down, you would be covered.
If not, then the auditor could question whether the requirements are being respected.
In order to demonstrate that the system works, you can perform a simulated recall and cover the complete supply chain.
Also, the Canadian distributor has to have an Establishment License by Canadian law, which requires the distributor to have a procedure for distribution records. Perhaps you can ask the Canadian Distributor for their procedure.

 

[Arnthor]

Dear all,

Thank you for all your valuable feedback.

To answer some of the questions:

-Yes my company is the holder of the Canada licence.

-The Canada importer had a procedure on retention record but they do not want to released to my company, they only give me their establishment licence. (this was rejected by the auditor)

So now I am asking Firm A to get in touch with Firm B and try to provide any evidence which they had complied with Canadian Medical Devices Regulations.

Best regards,

Arnthor