1. 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

2. Overview Changes to: Policy Regulatory Transparency and Openness
Guidance

3. 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

4. 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.

5. 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.

6. 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

7. 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 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:
Link for the New safety reviews:

8. 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

9. 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

10. Questions/comments
Thank you for your attention!