International Overview & Future Medical Devices Regulations

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International Overview & Future Medical Devices Regulations

  1. 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 International Regulatory Overview 1
  2. 2. Accept New Challenges International Regulatory Overview 2
  3. 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) International Regulatory Overview 3
  4. 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 International Regulatory Overview 4
  5. 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 International Regulatory Overview 5
  6. 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 International Regulatory Overview 6
  7. 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 International Regulatory Overview 7
  8. 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 International Regulatory Overview 8
  9. 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 International Regulatory Overview 9
  10. 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 International Regulatory Overview 10
  11. 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 International Regulatory Overview 11
  12. 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 International Regulatory Overview 12
  13. 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 International Regulatory Overview 13
  14. 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 International Regulatory Overview 14
  15. 15. Learn New Things International Regulatory Overview 15
  16. 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 International Regulatory Overview 16
  17. 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, International Regulatory Overview 17
  18. 18. Be Curious & Show Some Initiative International Regulatory Overview 18
  19. 19. International Regulatory Overview 19
  20. 20. Conclusion Thank you Medical Devices & Biosciences Int’l (MDBIO Int’l) Website WWW.Mdbioregulatory.ca International Regulatory Overview 20

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