Regulatory Committee Update

To:All DIAC Member Companies
From:Susanne Currie
Regulatory Affairs
Date:September 3, 2009
Subject:Regulatory Committee Update

One of the key initiatives of DIAC’s new Strategic Plan is to take a proactive approach in addressing our members’ regulatory needs. 

On March 31st of this year, a committee of 12 members – selected from the senior leadership and regulatory personnel of our manufacturing, dealer and laboratory membership – and our Executive Director met with Nancy Abbey – a government affairs consultant – to conduct a Regulatory Audit and Review, the purpose of which was to 

  • Review and prioritize DIAC Regulatory Issues for 2009 and beyond
  • Educate committee members about how to develop an Advocacy Plan
  • Provide a Health Canada Regulatory Update
  • Select 2 high priority regulatory issues affecting DIAC members, and
  • Take the initial steps in outlining DIAC Position Papers for those issues 

The Committee discussed 11 issues that were submitted for consideration and was able to consolidate and reduce them to two high-profile subjects, for which the Committee outlined Position Papers for further discussion. These were 

  • Grey Market, and
  • Health Canada Audit and Compliance 

Subsequent to this meeting, we formed a smaller Sub-Committee, composed of our President, Regulatory Director and two committee members with regulatory responsibilities and experience.  This Sub-Committee’s role was to provide feedback to complete a DIAC Environmental Scan and the DIAC Position Papers.  The Environmental Scan will provide committee members with

  • A review of the  current Medical Device Regulations in Canada, and
  • The opportunities that exist for DIAC to align with Health Canada and other organizations to address the regulatory issues of the Canadian dental industry.

We appreciate the extra effort we received from Debbie Bonello of 3M ESPE and Brian Thornton of Hespro Group for volunteering their own professional time to help the Sub-Committee move the Environmental Scan and Position Papers forward.

The Sub-Committee’s findings from the Environmental Scan were finalized on September 2nd and will be presented back to the whole Committee at a full-day meeting currently scheduled for September 30th. The Position Papers will also receive a final review and edit.

Once completed, we will be leveraging the information within the Environmental Scan to develop a DIAC Government Affairs Strategy and Implementation Plan that our Advocacy Team will use to prepare and rehearse for our meetings with Health Canada.

The Advocacy Team will be composed of the President, the Regulatory Affairs Director, the Executive Director, and any topical Regulatory Committee member whose expertise might be germane to the meetings.

We intend to schedule regular semi-annual meetings with Health Canada to discuss the concerns that our members have with the details and the administration of the Medical Device Regulations. At these meetings we will continue to present our concerns, monitor Health Canada’s progress in dealing with them, and report back to you.

Moving from a reactive regulatory posture, where we collect and distribute regulatory information to our members, to a proactive posture, where we try to continuously monitor and influence the regulatory environment, is a costly and time consuming activity. However, it aligns with DIAC’s objective of making a positive contribution to our members’ well being by acting together in the common interest.

We would sincerely like to thank all the members who have volunteered their time and energy to the Committee and Sub-Committees for this effort, and who have demonstrated that “co-opition” (cooperative competition) can drive benefits for all of us.