Several times throughout the year, clients ask me to help them prepare a slide for their Management Review that summarizes new and revised regulatory requirements. My recommendation is to conduct management reviews every quarter and to perform a systematic review of new and revised medical device regulations just before each management review.
Each country has different websites for communicating medical device regulations. For Canada, the information you need can be located in two places. The first location is the Justice Canada website, where the most current version of the Canadian Medical Device Regulations (CMDR) can be downloaded. The second location is the Health Canada webpage that lists legislation and guidance documents.
Identifying New and Revised Canadian Medical Device Regulations-Step 1
You need to look up the most recent version of the CMDR (http://bit.ly/FindCMDR). This link tells you how to search for the Medical Device Regulations on the Justice Canada website (http://bit.ly/Justice-Canada). When you type in “Medical Device Regulations” in the proper search field, it will take you to a page with a link for Canadian Medical Device Regulations (i.e., CMDR or SOR/98-282; http://bit.ly/CanadianMDR). Then you can decide if you want to download the CMDR in HTML, XML, or PDF format.
Why not click directly on the last link I provided?
Because the location on the Justice Canada website may change, and Health Canada does not control the Justice Canada website.
Once you download the CMDR, you want to compare it for changes with the previous version you were using. In June 2012, I wrote a blog that explains how to do this: http://bit.ly/CMDRChange. I’ll save you some time; however, the first page tells you what you need to know. The most current version of the CMDR is current to November 26, 2013 (it will change soon), but the last amendment was on December 16, 2011. Therefore, Health Canada has not made any changes to the wording of the CMDR in two years.
Once you have reviewed the CMDR, you will want to search for new guidance documents. Health Canada provides a page summarizing the medical device guidance documents in chronological order, from most recent to oldest: http://bit.ly/CanadianGuidance. There have only been four new guidance documents in the past two years:
1. http://bit.ly/LicenseApplications – Final guidance document for Class III and IV medical device license applications was released on July 5, 2012.
2. http://bit.ly/UltrasoundLicenseApps – Updated guidance license applications for ultrasound systems and transducers were published on September 13, 2013.
3. http://bit.ly/CanadianRenewalandFees – Updated guidance on license renewal and fees for the right to sell medical devices was released on November 18, 2013.
4. http://bit.ly/CanadianFeesforReview – Updated guidance on review fees for medical device license applications was released on November 18, 2013.
Note: The most recent fees are now found on the following page http://bit.ly/Canadian-Fees.
Review each guidance document and determine if the document impacts your organization’s quality system and procedures. This gap analysis should be performed by someone familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:
- initiate specific changes to existing procedures,
- create new procedures, or
- initiate a quality plan for more substantial changes to your quality system.
If you need more help preparing for your management review, here’s a link to a free webinar I recorded: http://bit.ly/Clause5-6. You will also receive a management review PowerPoint training slide deck.