Hi there,
You have the right one. Health Canada used to have their own recommended format, but would also accept the STED format, and more recently they have adopted the IMDRF ToC format. Looks like they officially prefer the IMDRF format now. They added the following box on the
old guidance:
January 2, 2020 - Please note that Health Canada has adopted the Table of Contents (ToC) format, developed by the International Medical Device Regulators Forum (IMDRF), as the recommended structure to be used in preparing Medical Device regulatory activities. The Draft Health Canada IMDRF table of contents for medical device applications guidance is available on the Health Canada website to provide guidance in preparing regulatory activities for Medical Devices using the ToC structure. Since April 2019, Health Canada has no longer been accepting regulatory activities for Medical Devices prepared using the Summary Technical Document (STED) structure. The information in Health Canada's IMDRF ToC document supersedes the requirements indicated in this Guidance document: Preparation of regulatory activities in the non-eCTD format. We intend to update the non-eCTD guidance document to reflect the amended requirements for all products filed in non-eCTD format, as soon as possible.
Karen
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Karen Long RAC
Vancouver BC
Canada
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Original Message:
Sent: 27-May-2020 16:24
From: Anonymous Member
Subject: Heath Canada License amendment application Guidance -IVD
This message was posted by a user wishing to remain anonymous
Hi ,
Can anyone help me out to understand if there is any specific Guidance document for License amendment for IVDs?
I found the below link but the guidance document doesn't look like an official release . Is there any specific format that we need to submit our significant change information in.
Thanks!
Class 3, in vitro diagnostic devices (IVD), new and amendment applicationshttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum/class-3-in-vitro-devices-new-amendment-applications.html