International Regulatory Overview 2009 Rev Linkedln

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International Regulatory Overview 2009 Rev Linkedln

  1. 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. 2. Accept New Challenges March 17, 2009 International Regulatory Overview 2
  3. 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) March 17, 2009 International Regulatory Overview 3
  4. 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 March 17, 2009 International Regulatory Overview 4
  5. 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 March 17, 2009 International Regulatory Overview 5
  6. 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 March 17, 2009 International Regulatory Overview 6
  7. 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 March 17, 2009 International Regulatory Overview 7
  8. 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 March 17, 2009 International Regulatory Overview 8
  9. 9. Health Canada March 17, 2009 International Regulatory Overview 9
  10. 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 March 17, 2009 International Regulatory Overview 10
  11. 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) March 17, 2009 International Regulatory Overview 11
  12. 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 March 17, 2009 International Regulatory Overview 12
  13. 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 March 17, 2009 International Regulatory Overview 13
  14. 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 March 17, 2009 International Regulatory Overview 14
  15. 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 March 17, 2009 International Regulatory Overview 15
  16. 16. Learn New Things March 17, 2009 International Regulatory Overview 16
  17. 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 March 17, 2009 International Regulatory Overview 17
  18. 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 March 17, 2009 International Regulatory Overview 18
  19. 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 March 17, 2009 International Regulatory Overview 19
  20. 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 March 17, 2009 International Regulatory Overview 20
  21. 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 March 17, 2009 International Regulatory Overview 21
  22. 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 March 17, 2009 International Regulatory Overview 22
  23. 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 March 17, 2009 International Regulatory Overview 23
  24. 24. Conclusion Thank you Medical Devices & Biosciences Int’l (MDBIO Int’l) Website WWW.Mdbioregulatory.ca March 17, 2009 International Regulatory Overview 24
  25. 25. March 17, 2009 International Regulatory Overview 25
  26. 26. Be Curious & Show Some Initiative March 17, 2009 International Regulatory Overview 26

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