New Class III medical device application for Health Canada

[celticfrosting]

Hi, I am compiling a new Class III medical device application for Canada. I am hoping someone has some advice on the registration process and can help answer the few questions I have. I am not overtly familiar with Canadian requirements and I see conflicting information online. The product is classified as Class III, license type - medical device system.

From looking online and at the Health Canada website I found the following forms and guidance’s –

• "Class 3, non-in vitro diagnostic devices (nIVD), new and amendment applications"
  • Which breaks down the application content for Class III devices.
• "Draft Health Canada IMDRF table of contents for medical device applications guidance"
  • it states the guidance is in Draft, but it gives a classification Matrix of the requirements (Section 4.3 C3/CIV nIVD Classification Matrix [Excel]) and Folder based samples to help build the sections (Section 4.2 nIVD Class 3 sample [zip]).
    • Can the application forms and Technical Documentation be submitted electronically as per Section 3.1.2? I may have seen an older guidance where it stated that the submission had to be a physical copy.
    • Is this the correct address and email for submission – Section 3.2.1? I’ve seen a different address elsewhere, I’m not sure if it was an older guidance.
    • When viewing the Classification Matrix Excel file, am I correct in only concentration on columns C3 N – Condition and C3 N – Condition?
      • Looking at the guidance I found the following information regards conditions - Required (R), Not Required (NR), Conditionally Required (CR), Optional (O), Optional but Recommended (OR)). Can I essentially concentrate on areas that are Required and Conditionally Required (CR) only?
• "New Class III Medical Device Licence Application Form" New Class III (July 2016)
  • Class III new application form
• "Medical Device Licence Application Fee Form [2020-03-23] [in effect April 1, 2020] – Class III Licence Application"
  • Looking at the folder samples and Matrix I believe the Application and Fee forms are combined with the technical data/documentation as one comprehensive submission.

I appreciate anyone’s expertise and knowledge. I want to be sure I am going down the correct avenue before I begin. Thanks.

 

[DannyK]

Hello,
In the past I also had issues finding the right versions of applications for Health Canada.
The old versions sometimes are buried in the Health Canada website.
Please refer to this page. Medical device application forms - Canada.ca

 

[RA Guy]

You should do an electronic submission per this guidance document:
Updated - Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format - Canada.ca

My company is very active with the Covid-19 response, otherwise I'd have more time to help "decode" these documents for you.
I noted you are in the USA. In my experience, Health Canada is typically more responsive and less formal than FDA in answering industry questions. I would not hesitate to put in a call for some advice if you are unsure or need to verify requirements or process. The staff are still working although I expect many/most are remote from the office.

I am limited to one link per post and will follow up with a few additional links to (hopefully) help you.

 

[RA Guy]

2nd link

Didn't see this one in your list:
Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs) - Canada.ca

 

[RA Guy]

3rd link

Additional current guidances found here:
Guidance documents – Medical devices - Canada.ca

 

[RA Guy]

4th link

Current information on Health Canada recognized standards and declarations of conformity found here:
Standards - Canada.ca

 

[RA Guy]

5th and final link - good luck !

Current info on fees and fee payment process found here:
Notice: New Fees and Policies for April 1, 2020 - Guidance Document Updates - Canada.ca