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International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
International Regulatory Overview   2009 Rev Linkedln
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International Regulatory Overview 2009 Rev Linkedln

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  • 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 March 17, 2009 International Regulatory Overview 2
  • 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. 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. 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. 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. 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. 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. Health Canada March 17, 2009 International Regulatory Overview 9
  • 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. 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. 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. 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. 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. 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. Learn New Things March 17, 2009 International Regulatory Overview 16
  • 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. 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. 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. 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. 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. 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. 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. Conclusion Thank you Medical Devices & Biosciences Int’l (MDBIO Int’l) Website WWW.Mdbioregulatory.ca March 17, 2009 International Regulatory Overview 24
  • 25. March 17, 2009 International Regulatory Overview 25
  • 26. Be Curious & Show Some Initiative March 17, 2009 International Regulatory Overview 26

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