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Canadian Medical Device Regulations (CMDR): Identifying New Changes

The author reviews a few methods to identify changes to the Canadian Medical Device Regulations (CMDR), including using the “compare” function in MS Word.

One of the most frustrating things about the Canadian Medical Device Regulations (CMDR), SOR/98-282, is the difficulty in identifying what has changed since the previous revision. There is no detailed revision history indicating what changed. This is surprising to me, because Canada was the first country to require ISO 13485 certification as a component of the regulatory approval process. Did the Therapeutic Products Directorate (TPD) overlook Clause 4.2.3?

Using MS Word to Compare CMDR Versions

Anyway, before I became an auditor, the way I determined what changed was to use the “compare” function in MS Word to compare the versions of the CMDR. The bottom of the first page indicates “Current to May 14, 2012.” This is our revision date, and it seems to change every month. Then below this, the document says, “Last amended on December 16, 2011.” This tells us that the last time TPD made a change was in December. Nowhere does CMDR tell us what changed.

On the second page of the CMDR, there is a note at the bottom of the page that supposedly clarifies the revision history:

“This consolidation is current to May 14, 2012. The last amendments came into force on December 16, 2011. Any amendments that were not in force as of May 14, 2012 are set out at the end of this document under the heading ‘Amendments Not in Force’.”

I have never seen a heading titled, “Amendments Not in Force.” So here’s what I do:

  1. “Select All” from the current PDF version of the CMDR and another version prior to the last amendment date: December 16, 2011.
  2. I copy and paste the text from each document into a separate MS Word document.
  3. I save each document with a different date code.
  4. I use the “compare” function to identify the revisions that were made to the pre-December version.
  5. Then I pound my forehead against my desk, because I just wasted 15 minutes to verify that the only changes made between August 8, 2011 and May 14, 2012 were as follows:
    • Date of revision throughout the document
    • Table of Provisions pagination was updated to reflect reformatting of Annex 3
    • Section 32.7 – changed wording from “may” to “shall,” and “giving” to “that gave”
    • Annex 3 was reformatted, so that the English and French versions appear side-by-side instead of on page 61 & 62 sequentially

Assessing the Impact of Change

So…the next time a third-party auditor asks you for objective evidence that you have assessed the impact of changes to the CMDR, show them this blog posting. If they force you to document the impact analysis of the change of the word “may” to the word “shall” in Section 32.7, request a new auditor quickly. If they ask for documentation of the impact of the tense change in Section 32.7, also request a new auditor quickly.

On a far less amusing note, the following new and revised regulatory requirements occurred on the TPD website:

  1. On May 31, 2012, there was an announcement by HC indicating “Categorization of Therapeutic Products at the Device/Drug Interface.”
  2. On October 19, 2011, the electronic submission pilot for Class IV devices was expanded to Class III devices: “Notice – Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application”; this revised guidance document includes a table for Class III applications based upon the STED guidance document from GHTF.

You can also type in “What’s New” into the search engine for the TPD website. The search results can be narrowed down to a year, and postings are typically no more frequent than monthly (eight in 2011; one in 2012).

You should also be aware of the third-party auditor report guidance document (GD211):Guidance on the Content of Quality Management System audit reports. This was released in June 8, 2011. You can also get training on this GD211 format at the US FDA website. The webinars are at the bottom of the list. This is part of the FDA’s Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.

If you are interested in learning more about the CMDR or CMDCAS, please join my LinkedIn CMDCAS Group.

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Posted in: Health Canada

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