Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format
Background and purpose
The International Medical Device Regulators Forum (IMDRF) has identified the need to harmonize the format of medical device market authorization applications. The Regulated Product Submission (RPS) working group of IMDRF has developed the Table of Contents (ToC) formats for both in vitro diagnostic (IVD) and non-in vitro diagnostic (nIVD) devices. As communicated in its August 21, 2018 notice, Health Canada intends to adopt the IMDRF ToC formats to encourage and support the global convergence of medical device regulatory activities towards a consensus format.
In support of this objective, Health Canada has consolidated existing guidance and IMDRF Guidance into a new set of tools and guidance pages.
The primary purpose of this notice is to announce the publication of this guidance. The notice also provides a brief outline of the content and layout of the guidance and provides details regarding the consultation approach and how feedback can be provided to Health Canada over the consultation period.
The Health Canada IMDRF ToC Implementation Guidance includes content relating to:
- Format/Structure requirements
- Content-related requirements
- Assembly and system requirements
With the exception of Special Access and Investigational Testing Authorizations, pre-market and post-market activities are within the scope of implementation of the ToC. For a complete, detailed, and up to date listing of regulatory activities within scope for the ToC implementation, refer to the main Draft Health Canada IMDRF ToC for Medical Device Applications Guidance.
Draft Health Canada IMDRF ToC for Medical Device Applications Guidance includes links to various content sub-pages based on the type of regulatory activity. In an effort to accommodate various users and their preferences, the guidance has been developed to offer multiple means of presenting the content guidance. For example, samples have been provided that show the guidance within a zipped folder structure which precisely matches the prescribed ToC folder structure. Further, tools are also provided including folder structure templates, listings of abbreviated folder names, and stand-alone classification matrices.
An experience-based consultation will be used for the Health Canada IMDRF ToC Implementation Guidance. Rather than a traditional consultation period where comments are collected over a brief period without any real world use of the guidance, Health Canada will publish draft versions of the guidance and will collect feedback over a 1-year period before publishing final versions. This will allow adaptation of the guidance through real world experience.
Consultation with industry will focus on approach and guidance format rather than content, as minimal new guidance content is introduced at this time and only minor content revisions may be included (e.g. to the referenced editions of international standards, removal of deprecated information).
Feedback forms are available upon request and should be completed by users during or immediately following the creation of their ToC formatted packages. To request a copy of the feedback form, email the Medical Device Bureau with the subject line "REQUEST for IMDRF ToC Implementation Guidance Feedback Form" (firstname.lastname@example.org). Completed feedback forms will be accepted by email with the subject line "COMPLETED IMDRF ToC Implementation Guidance Feedback" (email@example.com) until March 31, 2020.
Should you have any questions or comments relating to this notice, please contact the following:
Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Food Branch
Holland Cross, Tower A
11 Holland Ave., 2nd floor
Address Locator: 3002A
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