This document provides an overview of medical device regulations internationally, including in Canada, the United States, Europe, Australia, and Asia. It discusses key regulatory bodies and requirements in each region. It also summarizes Canada's 2007-2012 strategies to modernize its regulatory framework and program, strengthen human resources and funding, improve governance, and foster stakeholder partnerships. Recognition of standards and relationships between different quality systems are also covered. The presentation aims to help organizations understand and navigate international medical device regulations.

1. International Overview
& Future of Medical Devices Regulations
Canada - USA - Europe - Australia - Asia
By : Roger Leclerc – Speaker
Title : Senior Director, Regulatory Affairs & Export
Date: 2009
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2. Accept New Challenges
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3. Introduction
Medical Devices Regulatory Overview - Country
3. Canada - Therapeutic Products Directorate (TPD)
4. United States - Food & Drug Administration (FDA)
5. Europe - Competent Authority (TUV, BSI) - Member
States
6. Australia - Therapeutic Goods Administration (TGA)
7. Asia - Ministry of Health (MHLW - SFDA)
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4. Canada
 Regulatory & Program Modernization of the Food &
Drug Act
 Enforcement Powers
 Inspection Strategy & Program - Life Cycle of a Medical
Device
 Surveillance & Safety & Effectiveness Monitoring
 Invaluable & Experienced Resource Planning
 Adequate Funding - Meet Requirements & Performance
 Admin. Governance - Decisions within Performance
Standards
 International Transparency & Stakeholder framework
 Performance Measurement Framework for success &
improvement
 Standards Recognition
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5. United States
 Disputes Concerning Payment or Refund of Medical
Device User Fees
 User Fees & Refunds for Premarket Notification
Submissions
 Guidance on Postmarket Issues
 Device Specific Guidance's
 Standards Related Guidance's
 Cross-Cutting & Process Guidance
 CDRH Enforcement Discretion
 510(k) Paradigm
 Summary Technical Documentation for Demonstrating
Conformity to the Essential Principles of Safety &
Performance
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6. Europe
 Medical Devices Directive (90/385/EEC and 93/42/EEC2)
 Risk-Based Classification
 Non-Regulated Medical Devices
 Implantable / Invasive Devices for Aesthetic Purposes
 Revision of the "New Approach"
 Essential Requirements
 National Specific Requirements
 Notified Bodies
 Info exchange Notified Bodies & Competent Authorities
 Cooperation between Competent Authorities
 Safeguard clause & withdrawal of certificate
 Vigilance
 Market surveillance
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7. Australia
 Regulation of custom made medical devices
 Third Party Conformity Assessment Bodies for Medical
Devices Supplied in Australia
 Technical Review of the Code of Practice for the
Tamper-Evident Packaging (TEP)
 General requirements for labels for medicines
 Remedial actions for medical devices
 Review of TGA actions
 Conformity assessment overview
 Conformity assessment for manufacturers
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8. Asia
 Japan Revises GCP for Medical Devices & Drugs
 Indonesia Orders Foreign Drug makers to Manufacture In-
Country
 Diabetes Increasing Rapidly in China - Glucose Monitors
 India Proposes Quality Certification for Medical Devices
 Japan Works to Cut Drug and Device Lag
 Taiwan To Create Food & Drug Administration For Food &
Drug Safety
 Singapore Tightens Regulation on Medical Device
Advertising
 India Cracks Down on Fake Drugs
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9. Medical Devices Strategies Canada – 2007 - 2012
1. Regulatory & Program Modernization
 Strength safety oversight by adoption of life cycle
approaches
 Increase & Strengthen Regulatory Tools and Abilities
 Identify shared activities with other jurisdictions
 Develop programs to provide consequences for Non-
compliance with regulations
 Investigational testing regulations – amended
 Investigational testing inspection strategy & program
 Post Market Activities, Surveillance & Safety &
Effectiveness monitoring – Risk basis
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10. Medical Devices Strategies Canada – 2007 - 2012
2. Human Resources
 Knowledge transfer – talented staff
 HR Planning – skills, experience - future
 Training of staff due to sciences & technology
 Develop a culture of cross training
 Working together – three different directorates
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11. Medical Devices Strategies Canada – 2007 - 2012
3. Adequate Funding
 Cost recovery - regulation, licensing & post market
surveillance
 Branch - Comprehensive Review of programs &
Resources to ensure adequate funding
 Identify gaps in its activities to meet strategies - Cabinet
& Treasury Board to finance programs not funded by
Recovery Cost
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12. Medical Devices Strategies Canada - 2007- 2012
4. Governance & Business Transformation
 Manage better with current Structure
 Meetings – Three Directorate to discuss Medical Devices
Issues i.e. funding for programs - explore
- Therapeutic Products Directorate (TPD)
- Marketed Health Products Directorate (MHPD)
- Health Products and Food Branch Inspectorate (HPFBI)
 Review of Structural Options for Longer Term
- long term organizational structures to handle medical
devices issues as the industry grows
- Develop service standards – i.e. MDEL
- Develop Performance Measurements for all aspects of
the Medical Devices Program - outlining sustainable
activities
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13. Medical Devices Strategies Canada - 2007-
2012
5. Partnerships, Effective, Transparent Communication
 Focus Approach to International Cooperation
- Global Harmonization Task Force (GHTF)
- Food Drug Administration (FDA)
- Therapeutic Goods Administration (TGA)
- Harmonization of Regulatory System - Medical
Devices - provide expertise – International & National
Standards
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14. Medical Devices Strategies Canada - 2007- 2012
 Strong & Positive Partnerships with Stakeholders
- Develop joint activities - organization - associations
- Canadian Border Services Agency - Non-compliant
devices entering Canada
- Engage stakeholders and provincial regulatory authorities to
discuss and plan end user training - high risk devices
 Improve Communications with Stakeholders
- Identify & improve timeless of communications
- Registration & disclosure of Clinical Trial Information
- Rely on - Expert Advisory Committee – Mechanisms improve
stakeholder Communications
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15. Learn New Things
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16. Regulatory Authority & Stakeholder Outcome - 2008 - 2009
1. Standards Recognition
 New list of Recognized Standards Updated Feb 2008
 Proposal to Remove 2nd Edition Dec. 15, 2008 & Move
forward with Third Edition of IEC 60601-1
 Input from the Medical Devices Companies is
forthcoming to discuss appropriate way to move
forward with 3 rd edition of 60601-1 & its associated
standards
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17. Other Quality Systems
Relationship & Compatibility
1. Europe CE -> ISO 13485:2003 Medical Devices
2. USA -> Quality System Regulations
- CFR 20 – 820 Medical Devices
- Goods Manufacturing Practices (GMP)
3. Differ in specific areas i.e. Recall, Sterilization,
Premarket Approval,
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18. Be Curious & Show Some Initiative
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19. International Regulatory Overview 19

20. Conclusion
Thank you
Medical Devices & Biosciences Int’l (MDBIO Int’l)
Website WWW.Mdbioregulatory.ca
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