New Class III medical device application for Health Canada

celticfrosting

Starting to get Involved
#1
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.
 
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RA Guy

Involved In Discussions
#3
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.
 
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