Kimby N. Barton Interim Director Medical Devices Bureau Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Kimby N. Barton Interim Director Medical Devices Bureau

Overview Changes to: Policy Regulatory Transparency and Openness Guidance

Policy Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices as Medical Devices Notice published on Health Canada web site on September 14, 2016 Intent for reclassification is to be in line with international regulators Work is ongoing to develop an action plan indicating the transition process, timelines and licensing requirements

Policy Preparation of Medical Device Regulatory Activities in an electronic-only format Notice published on Health Canada web site December 14, 2016 Sets out regulatory activity types that can be submitted in an electronic format Paper copies of regulatory activities set out in the notice will no longer be accepted after April 1, 2017.

HPFB Regulatory Transparency and Openness Initiatives Posting of Regulatory Decision Summaries Positive decisions for new Class IV medical device licence applications filed after April 1, 2015 Negative decisions for new Class IV medical device licence applications filed after April 1, 2016 Posting of annual inspection summary reports Posting of regulatory Forward Plans Posting of safety review summaries Expansion of the Health Product Register Making performance data publically available Regulatory Decisions Summaries are Health Canada documents that are intended to communicate the rationale for Health Canada's decisions. The documents have been designed to convey the purpose of the submission and the reason for the decision that was issued.

Regulatory Transparency and Openness Initiative Posting of Regulatory Decision Summaries Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization. They include: Purpose of submission Reason for the decision Summaries of certain submissions that were accepted into review and subsequently cancelled by the sponsor 110 (as of Feb 10) positive decisions for new Class IV medical device licence applications posted after April 1, 2015 No (as of Aug 24) negative decisions for new Class IV medical device licence applications posted after April 1, 2016

Regulatory Transparency and Openness Initiative Posting of List of New Safety Signals under Review and Summary of the Safety Reviews (SSR) completed As part of the ongoing commitment to openness and transparency initiative, Health Canada (HC) is publishing summaries of its safety reviews Each summary outlines what was assessed, findings, and the action taken by HC (if any) Three SSRs posted in 2016 Background for your information. As part of the Openness and Transparency initiative HC has started posting the list of safety issues under review along with the SSR for pharmaceuticals and biologics on April 2014. The project is now expanded to include Medical devices safety issues. As of April 2016 we have issued two SSRs: - Essure permanent birth control and risk of complications. Posted on May 25, 2016 Trifecta Heart Valves and potential risk of Early Wear. Posted on August 25, 2016. The link for the SSRs is: http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/ssr-rei-eng.php Link for the New safety reviews: http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/new-nouveaux-eng.php

Guidance Documents Preparation of Regulatory Activities in the “Non- e-CTD Electronic-Only Format Applications for Investigational Testing Authorization (ITA) for Medical Devices, in the Non-eCTD Electronic-Only Format Final Guidance on the Preparation of Premarket Medical Device and Licence Amendment Applications for Dermal Fillers

Upcoming Documents Revisions to Guidance document on regulation of medical devices manufactured from or incorporating viable or non-viable animal tissue or their derivatives Revisions to the Preparation of an Application for Investigational testing- Medical Devices

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