1. International Regulatory Overview
Canada - USA - Europe - Australia - Asia
By : Roger Leclerc - Speaker
Title : Senior Director, Regulatory Affairs & Export
Date: March 17, 2009
March 17, 2009 International Regulatory Overview 1

2. Accept New Challenges
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3. Overview
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’s Challenges
 Regulatory & Program Modernization of the Food &
Drug Act
 Enforcement Powers - Consequences Non-Compliance
 Life Cycle of a Medical Device - Develop Investigational
Testing Inspection Strategy & Program
 Proactive - Surveillance of Safety & Effectiveness &
Post Market Activities - Inspections
 Experienced Resource Planning - Knowledge Transfer
 Adequate Funding - Meet Requirements
 Admin. Governance - Performance Standards
 International Transparency & Stakeholder framework
 Performance Measurement Framework for Success &
Continuous Improvement - Regulatory Process
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5. United States - Challenges
 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’s - Challenges
 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’s - Challenges
 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’s - Challenges
 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. Health Canada
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10. Medical Devices Strategic Objective - 2012
1. Regulatory & Program Modernization
 Strengthen safety oversight - Adopt of life cycle
approaches - Risk Management Framework
 Increase & Strengthen Regulatory Tools and
Abilities - Learn & Share - Jurisdictions
 Identify shared activities with other jurisdictions
 Develop programs to provide consequences for
Non-compliance with regulations
 Amend Investigational Testing Regulations
 Investigational Testing Inspection Strategy &
Program - Compliance to GCP - Reporting to HC
 Strengthen Post Market Activities, Surveillance &
Safety & Effectiveness monitoring - Risk basis
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11. Medical Devices Strategic Objective - 2012
2. Human Resources
 Knowledge transfer - talented staff
 HR Planning - skills, experience - future
 Training of staff due to science & technology
 Develop a culture of cross training
 Working together - Three different directorates
 Therapeutic Product Directorate (TPD), Health
Products and Food Branch Inspectorate (HPFBI),
Marketed Health Products Directorate (MHPD)
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12. Medical Devices Strategic Objective - 2012
3. Adequate Funding
 Cost recovery – Charging framework to cover the
regulation, licensing & post market surveillance of
health products & medical devices
 Branch - Comprehensive review of programs &
resources to ensure adequate funding to deliver
mandated activities
 Identify gaps in its activities - for emerging issues &
meet strategies - Cabinet & Treasury Board to finance
programs not funded by Recovery Cost
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13. Medical Devices Strategic Objective - 2012
4. Governance & Business Transformation
 Manage better - current Structure - Collaboration of
the Directorate & Inspectorate to discuss Medical
Devices Issues i.e. funding for programs
 Therapeutic Products Directorate (TPD), Marketed
Health Products Directorate (MHPD), Health Products
and Food Branch Inspectorate (HPFBI))
 Review of Structural Options for Longer Term
- Review organizational structures to handle device
issues as the industry grows, Develop service
standards - i.e. MDEL issuance
- Develop Performance Measurements for all aspects
of the Medical Devices Program - outlining
sustainable activities
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14. Medical Devices Strategic Objective - 2012
5. Work in Partnerships, Effective, Transparent
Communication
 Focus Approach to International Cooperation
- Global Harmonization Task Force (GHTF) - Share
activities with Food Drug Administration (FDA),
Therapeutic Goods Administration (TGA)
- Harmonization of Regulatory System - Medical
Devices - provide expertise - International & National
Standards
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15. Medical Devices Strategic Objective - 2012
 Strong & Positive Partnerships with Stakeholders
- Develop joint activities - organization - associations
- Canadian Border Services Agency - Address 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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16. Learn New Things
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17. Regulatory Issues & 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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18. Regulatory Issues & Outcome - 2008 - 2009
2. Special Access Program
 Advisory Panel - Provide Options - Posted
 Review documentation by Health Canada, listen to
presentations at a public forum
 Make propose recommendations and various options
for modernizing the Special Access Program
 A Report will be prepared and will be posted to the HC
website.
 Industry - invited to provide input
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19. Regulatory Issues & Outcome - 2008 - 2009
3. Significant Changes
 MDB increasing significant changes following recalls -
safety & effectiveness
 Industry is stating other jurisdiction is non significant
 MDB has instructed industry to discontinue sale of the
device
 MDB will expedite significant change amendments
related to a recall
 Industry is stating - Corrective & Preventative Actions
part of a recall must be clear and harmonized with other
jurisdictions
 MDB has invited industry to provide input - before
revision of the guidance document
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20. Regulatory Issues & Outcome - 2008 - 2009
4. Sale of Unlicensed Devices
 Industry - Hospitals, Buying Groups, Dealers, receiving
quotes - new devices coming to Canada & unlicensed
 MDB - A purchase process - based on promotion could
be viewed as an activity vs. regulations
 HC- No Intention to sell a device
 Not used on an individual
 Label the device not licensed in accordance with
Canadian Law
 Return device out of Canada if at a tradeshow
 The device to be under direct control of the company at
all times
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21. Regulatory Issues & Outcome - 2008 - 2009
5. Device Establishment Licence
 Section 44(1) No person shall import or sell a medical
device unless - Establishment License
 Importers wish to sell product - new manufacturer or
new class from current manufacturer - applicant cannot
import or sell these products until receipt of amended
MDEL
 Currently the one form - Requires 15 day notification -
for administrative changes on the current MDEL i.e.
corporate name changes, contact person
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22. Regulatory Issues & Outcome - 2008 - 2009
6. New Food & Drug Act Liaison Office (FDALO)
 Aimed at preventing & resolving disputes with
Stakeholders
 Mandate - Receive complaints, concerns or inquires -
alleged acts, omissions, matters related to Food &
Drugs Act, listen, offer options, facilitate, investigate
 FDALO has no statutory powers to investigate- not give
legal advice - change policies -
 Ms Serena Siqueira Director of the Food and Drugs Act
Liaison Office - Handle concerns from manufacturers -
license delays - lack of consistency
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23. Regulatory Issues & Outcome - 2008 - 2009
7. Modernization of the Food and Drug Act
 Minister Clement Introduced Bill C-51 - April 2008
 Proposes the modernization of how HC regulates
therapeutic products
 Supports the implementation of a life cycle approach
(Progressive Licensing) to the regulations of medical
devices & pharmaceuticals
 Industry requested that the term Recall be explored to
 Progressive Licensing -
www.healthcanada.gc.ca/progressive_licensing
 Bill C-51 - http://www.parl.gc.ca/legisinfo/index.asp?
Language=E&Session=15&query=5420&List=toc
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24. Conclusion
Thank you
Medical Devices & Biosciences Int’l (MDBIO Int’l)
Website WWW.Mdbioregulatory.ca
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25. March 17, 2009 International Regulatory Overview 25

26. Be Curious & Show Some Initiative
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