Pre Event Resources CAPRA 2025 Medical Device and Combination Product - Dec 03, 2025

7:00 - 8:00 am

Opening Remarks, followed by Q&A
1. Presentation

Bruce Randall, Director General, Medical Devices Directorate, Health Canada.

Overview of the MLMD guidance and its impact on the industry, followed by Q&A
2. Presentation

Marc Lamoureux, Manager, Digital Health Division, Bureau of Evaluation, Medical Devices Directorate (Virtual)

Medical Device Guidance Update,
followed by Q&A
3. Presentation

Discussion on policy and guidance updates: Management of Applications for Medical Device Licences, including the revised reconsideration process, the new additional information request option, and the guidance document on how to interpret “Significant changes”.

Sharing the impacts of agile licensing for medical device manufacturers as outlined in the guidance on Agile licensing for medical devices.

Sally Prawdzik, Director, Bureau of Policy and International Programs, Medical Devices Directorate 

Matthew Ryan, Manager, Office of Regulatory and Strategic Activities, ROEB

Common Medical Device submission deficiencies, followed by Q&A
6. Presentation

MDD’s Director of the Bureau of Licensing Services will discuss a few common challenges with license applications, as well as tips and tricks to facilitate the application process, including the meeting request framework 

Colin Foster, Director, Bureau of Licensing Services, Medical Devices Directorate, Health Canada

Medical device submissions deficiencies from the industry Perspective, followed by Q&A
 7. Presentation

Medtech Canada has been working alongside Health Canada to provide industry signals for areas of concern and improvement.  Mia will discuss a bit of the historical collaboration, areas of success, and ongoing engagement.

Mia Spiegelman, VP, Regulatory, Quality and Environmental Affairs, Medtech Canada

How can the industry navigate regulatory operations for medical devices and combination products using artificial intelligence, followed by Q&A
8. Presentation

AI will not replace RA specialists. Instead, AI will enchance regulatory intelligence by helping RA teams predict regulatory outcomes, handle data, automate processes, and support decision-making, thereby enabling the development of more combination medical device products.

Tanima Ghosh, Senior Executive, QMB-Qualiverse

Medical Device Classification and Combination Product, followed by Q&A
9. Presentation

This session will discuss how Health Canada classifies combination products. 

Colin Foster, Director of the Bureau of Licensing Services, Medical Devices Directorate, Health Canada.

Regulation of Drug Delivery Systems from the Industry Perspective, followed by Q&A
10. Presentation

This presentation will focus on the nuances of how drug delivery systems are regulated by Health Canada, for example, the impact of how it is co-packaged and the intended use of individual components.

Mary Speagle, Senior Director, Regulatory Affairs, Innomar Strategies Inc.

Overview of the Combination Product from the FDA's perspective, followed by Q&A
11. Presentation

Overview of Device or Device-Lead Combination Product Submission Process and Jurisdiction

Nazia Rahman, Policy Analyst, CDRH Product Jurisdiction, CDRH OPEQ, FDA  

Combination Products and MDSAP – what to expect, followed by Q&A
12. Presentation

Fred Hamelin, Manager, Quality Systems Section, Bureau of Planning and Operations, Medical Devices Directorate, Health Canada 

PM Break

Industry Perspective on the Medical Device Single Audit Program (MDSAP), followed by Q&A
13. Presentation

The role of industry as a participant in MDSAP is evolving.  As the system becomes more mature, collecting and providing insights on areas of improvement and enhancement are key to continued adoption and success within international communities and jurisdictions.  Mia will discuss various industry-led collaborations taking place both directly and indirectly in support of MDSAP. 

Mia Spiegelman, VP, Regulatory, Quality and Environmental Affairs, Medtech Canada

Overview of Medical Devices Compliance Program from a Compliance and Enforcement Perspective, followed by Q&A
14. Presentation

Gain a comprehensive understanding of the current structure, new initiatives, and key priorities of the Medical Devices Compliance Program. The session will offer an overview of the Medical Devices Establishment Licence Inspection and the Medical Devices Compliance Verification Programs, emphasizing the risk-based inspection approach, essential aspects of triaging complaints and recalls, and common findings from inspection activities. Participants will also receive insights into regulatory expectations and best practices to support compliance. 

Erin Skuce, Director, Medical Devices Compliance Program, ROEB, Health Canada.

7:00 - 8:00 am

Opening Remarks, followed by Q&A

Bruce Randall, Director General, Medical Devices Directorate, Health Canada.

Overview of the MLMD guidance and its impact on the industry, followed by Q&A

Marc Lamoureux, Manager, Digital Health Division, Bureau of Evaluation, Medical Devices Directorate (Virtual)

Medical Device Guidance Update,
followed by Q&A

Discussion on policy and guidance updates: Management of Applications for Medical Device Licences, including the revised reconsideration process, the new additional information request option, and the guidance document on how to interpret “Significant changes”.

Sharing the impacts of agile licensing for medical device manufacturers as outlined in the guidance on Agile licensing for medical devices.

Sally Prawdzik, Director, Bureau of Policy and International Programs, Medical Devices Directorate 

Matthew Ryan, Manager, Office of Regulatory and Strategic Activities, ROEB

Common Medical Device submission deficiencies, followed by Q&A

MDD’s Director of the Bureau of Licensing Services will discuss a few common challenges with license applications, as well as tips and tricks to facilitate the application process, including the meeting request framework 

Colin Foster, Director, Bureau of Licensing Services, Medical Devices Directorate, Health Canada

Medical device submissions deficiencies from the industry Perspective, followed by Q&A
 

Medtech Canada has been working alongside Health Canada to provide industry signals for areas of concern and improvement.  Mia will discuss a bit of the historical collaboration, areas of success, and ongoing engagement.

Mia Spiegelman, VP, Regulatory, Quality and Environmental Affairs, Medtech Canada

How can the industry navigate regulatory operations for medical devices and combination products using artificial intelligence, followed by Q&A

AI will not replace RA specialists. Instead, AI will enchance regulatory intelligence by helping RA teams predict regulatory outcomes, handle data, automate processes, and support decision-making, thereby enabling the development of more combination medical device products.

Tanima Ghosh, Senior Executive, QMB-Qualiverse

Medical Device Classification and Combination Product, followed by Q&A

This session will discuss how Health Canada classifies combination products. 

Colin Foster, Director of the Bureau of Licensing Services, Medical Devices Directorate, Health Canada.

Regulation of Drug Delivery Systems from the Industry Perspective, followed by Q&A

This presentation will focus on the nuances of how drug delivery systems are regulated by Health Canada, for example, the impact of how it is co-packaged and the intended use of individual components.

Mary Speagle, Senior Director, Regulatory Affairs, Innomar Strategies Inc.

Overview of the Combination Product from the FDA's perspective, followed by Q&A

Overview of Device or Device-Lead Combination Product Submission Process and Jurisdiction

Nazia Rahman, Policy Analyst, CDRH Product Jurisdiction, CDRH OPEQ, FDA  

Combination Products and MDSAP – what to expect, followed by Q&A

Fred Hamelin, Manager, Quality Systems Section, Bureau of Planning and Operations, Medical Devices Directorate, Health Canada 

PM Break

Industry Perspective on the Medical Device Single Audit Program (MDSAP), followed by Q&A

The role of industry as a participant in MDSAP is evolving.  As the system becomes more mature, collecting and providing insights on areas of improvement and enhancement are key to continued adoption and success within international communities and jurisdictions.  Mia will discuss various industry-led collaborations taking place both directly and indirectly in support of MDSAP. 

Mia Spiegelman, VP, Regulatory, Quality and Environmental Affairs, Medtech Canada

Overview of Medical Devices Compliance Program from a Compliance and Enforcement Perspective, followed by Q&A

Gain a comprehensive understanding of the current structure, new initiatives, and key priorities of the Medical Devices Compliance Program. The session will offer an overview of the Medical Devices Establishment Licence Inspection and the Medical Devices Compliance Verification Programs, emphasizing the risk-based inspection approach, essential aspects of triaging complaints and recalls, and common findings from inspection activities. Participants will also receive insights into regulatory expectations and best practices to support compliance. 

Erin Skuce, Director, Medical Devices Compliance Program, ROEB, Health Canada.

7:00 - 8:00 am

Opening Remarks, followed by Q&A
Bruce Randall, Director General, Medical Devices Directorate, Health Canada.

Overview of the MLMD guidance and its impact on the industry, followed by Q&A
Marc Lamoureux, Manager, Digital Health Division, Bureau of Evaluation, Medical Devices Directorate (Virtual)

Medical Device Guidance Update, followed by Q&A
Sally Prawdzik, Director, Bureau of Policy and International Programs, Medical Devices Directorate 
Matthew Ryan, Manager, Office of Regulatory and Strategic Activities, ROEB

Common Medical Device submission deficiencies, followed by Q&A
Colin Foster, Director, Bureau of Licensing Services, Medical Devices Directorate, Health Canada

Panel Discussion for All Topics and Closing Remarks

All Speakers