To add to the responses, I suggest you also review the 2016 Health Canada guidance document,
Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format. Per the Policy Statements section of this document:
Health Canada has been accepting Class III and IV medical device applications in electronic and paper format since November 2014. Effective immediately, Health Canada is accepting all medical device applications in scope of this guidance document to be provided in "non-eCTD electronic-only" format. Until the Regulated Product Submission (RPS1) format has been implemented, "Non-eCTD electronic-only" will be the only format accepted by Health Canada for medical devices applications as of April 1st, 2017. Therefore paper will no longer be accepted as of this date.
Class II Medical Device Licence Applications are included in the scope of the guidance.
Jennifer
------------------------------
Jennifer Cabralda, RAC (US, CAN)
Richmond, BC, Canada
------------------------------
Original Message:
Sent: 26-Jun-2018 03:16
From: Richard Vincins
Subject: Health Canada Class 2 License Application Questions
Hello,
A couple I did recently were from 30 - 50 days, one took longer because they wanted some additional labeling information. Yes, you can send electronic, but I still send in both electronic and hard copy for tracking purposes. Until agencies have full e-submission processes, I want to make sure they get the "whole" file as email sometimes drops off large or larger files.
------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
Original Message:
Sent: 25-Jun-2018 16:23
From: Meenakshi Verma
Subject: Health Canada Class 2 License Application Questions
Hi,
With regard to your below query:
I was wondering what the average review time for a Health Canada Class 2 submission is these days. - 45 days as per my experience.
Can the application be turned in via email? - Yes, you can send via e-mail if the file size is less than 20MB.
When the review is complete, is the license sent via email? - Yes, if there are no queries - MDL is received via e-mail.
Thank you.
------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
Original Message:
Sent: 25-Jun-2018 15:59
From: Anonymous Member
Subject: Health Canada Class 2 License Application Questions
This message was posted by a user wishing to remain anonymous
I was wondering what the average review time for a Health Canada Class 2 submission is these days. Can the application be turned in via email? When the review is complete, is the license sent via email? Thank you.