RAC engages with Health Canada (and provincial governments) to: provide insights on regulatory policies that lead to a safe and effective market for medical devices; reflects the commitment to alignment with other regulators; fosters a vibrant, innovative medical technology industry in Canada; establishes strong stakeholder relations; and a permanent dialogue on developing policies. 

 Greg Leblanc / Stefan Fei

Medtech Canada’s Regulatory Affairs Cost-Recovery and Performance Sub-Committee collaborates with Health Canada through an open, transparent, and continuous exchange of key performance indicators, economic indicators, and stakeholder feedback on the topics of Health Canada’s performance trending, regulatory predictability, cost and process efficiency across the Canadian medical technology regulatory environment. These exchanges represent the ongoing shared commitments towards cost-effective and timely regulatory review performance towards maintaining the safe and effective, globally competitive, and innovative medical technology industry in Canada. 

 Charles Tam

The scope of the Regulatory Affairs Diagnostic Imaging sub-committee is to focus on regulatory matters relating specifically to the Diagnostic Imaging sector, primarily CT, MR, X-ray, PET, SPECT, endoscopes and Ultrasound. The sub-committee monitors, evaluates and comments on revised and emerging provincial and federal legislation, regulation and standards that apply specifically to the Imaging sector – most commonly related to radiating emitting or detecting devices and their importers/distributors/service providers. Additionally, the sub-committee advocates for regulatory framework that supports Canadian innovations in the Diagnostic Imaging Sector.

  Stefan Feix

The scope of the digital Health sub-committee is to focus on regulator matters relating specifically to medical device software [both for software as a medical device (SaMD) and software in a medical device (SiMD)].  The sub-committee monitors, evaluates and comments on revised and emerging regulating and guidance that apply specifically to software, including classification of software, artificial intelligence, machine learning, remote monitoring solutions, VR and AR, cybersecurity and 3D printing.

 Ugbaad Elmi / Diane Johnson

 Tonino Antonetti

The scope of the Regulatory Affairs Premarket Sub-committee is to focus on matters that relate to all premarket (before approval to market is granted by Health Canada) regulatory matters.  The subcommittee tackles pre-market licencing concerns and topics regarding new and existing regulations and guidelines. Where certain items require more focused concern, the subcommittee may create a separate Taskforce or engage other Subcommittee support.  The Premarket subcommittee collaborate with Health Canada on matters of pre-market and fosters a vibrant, inclusive and collaborative work among its members.

 La-Toya Salmon / Cathernie Matthews

The scope of the Regulatory Affairs Post-Market Subcommittee is to focus on and discuss changes in guidance and/or regulations on activities which organizations are required to implement and maintain (or support) following the receipt of a market authorization of a medical device.  This includes vigilance reporting such as complaints, reportable events, summary reporting, foreign risk notifications as well as recalls. The Subcommittee additionally tackles renewal (MDL/MDEL) and audits (Health Canada).
The Post-Market subcommittee collaborate with Health Canada on matters of post-market issues and concerns and fosters a vibrant, inclusive and collaborative work among its members.

 Inga Brencis / Vivek Patel

 Greg Leblanc

 Mary Semplicio / Seema Vyas

The Regulatory Cooperation Council Committee focuses on reducing regulatory burden caused by country specific requirements by proposing alignment with other regulatory authorities/jurisdictions.  Industry members identify specific areas of concern and prepare a position statement/proposal for submission to the targeted authority.  The Committee engages in consultations and stakeholder forums held between Canada-US and Canada-EU (CETA) to ensure views are tabled, pathways are identified in workplans, and the medical device sector is represented.

 Kelly Makimoto