Registration of Class IV Device -Clinical Data and ISO Certificate

D

danush

#1
Hello all,

My company is about to submit a design dossier for CE marking together with ISO 13485 certification. in case we want to simultaneously get certified for Canadian ISO 13485, I have several questions:
1. Do we need to have additional tech file complying with Canada MDR for the audit?
2. Clinical data type- for CE mark we conducted a literature survey on devices considered equivalent to our device. Would it satisfy Canadian MDR or do we need to conduct actual clinical invetsigation before we can apply for Canadian license?

Thank you.
 
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sreenu927

Quite Involved in Discussions
#2
Hi Danush,

1. For Q1, No, there is no need to have additional tech file for CMDR audit. You can use the same CE design dossier. But make sure, you address all the requirements in your CE design dossier and the relevant SOPs, esp,
i) Significant change reporting SOP,
ii) Product recall and Adverse Event SOPs with reporting timelines as per Canada, along with other countries' timelines (as per your market presence);

and the safety instructions must be in French translation for the product instructions for use(IFU) or user guide.

2. If you are confident enough to convince the Notified Body with only literature survey for a high risk device, then it shud be okay. however, I believe the Health Canada ISO 13485 Certification body registrar would insist to have clinical trials, as it is a class IV Medical device and even the Notified Body aswell. I think, you need to discuss with your NB on this. If agreed, then you may have some confidence to support for having literature survey only.

Regards,
Sreenu
 
D

danush

#3
Thanks Sreenu,

I will need to check CAN ISO13485 to identify the additional requirements for quality system.

Our NB has basically agreed to literature based clinical evaluation. Will see if eventually it will be sufficient. But I have a filling that to have CMDR license it won't be enough.

I have to clarify one thing, though. The ISO certification is separate from the device registration which is done with Ministry of Health and should be done before premarket review document submission. So if I don't have French translation at the time of ISO audit or the design dossier is not finilized yet, will it be a problem with regard to ISO certification?
 

RA Guy

Involved In Discussions
#4
danush

There are no additional requirements in CANISO 13485 vs. the "generic" version.
Additiomnal requirements can be found in the CMDR.

You must ensure your NB is recognized by Health Canada and so can provide you with a CMDCAS ISO13485 certificate.

The French translation is not required during the audit or licencing process as long as the product is not sold directly to the public. If only one language is provided at the time of sale, the other must be available upon request of the purchaser. Reference Sec. 23 of the regulations for the exaclt wording of this requirement.
 
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