Reg summary

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Reg summary

  1. 1. Cochlear and Medical DeviceRegulationsRegulatory AffairsCochlear Limited
  2. 2. Why are you here?• To acquire knowledge of the core of medicaldevice regulations• To develop a consistent understanding of theregulations• To have reinforced how the regulations affectsyour role• To have an opportunity to have any uncertaintiesregarding medical device regulations clarified
  3. 3. Modules• Medical Device Regulation Basics• Medical Device Standards• Quality Management System Audits• Product Approvals and management of changes• Postmarket surveillance
  4. 4. An Overview of the Landscape:Who are the RegulatoryAgencies
  5. 5. Why Regulations
  6. 6. RegulationsRegulation is"controlling human or societal behavior by rules orrestrictions.“Regulation mandated by a state attempts to• produce outcomes which might not otherwise occur,• produce or prevent outcomes in different places towhat might otherwise occur, or• produce or prevent outcomes in different timescalesthan would otherwise occur .
  7. 7. Regulators’ perspectives - TGAVision:• We aim to be recognised as a world leader inadvancing and protecting public health and theenvironment through scientific and regulatoryexcellence.Mission:• We will develop and implement appropriate nationalregulatory policies and controls for medicines, medicaldevices, blood, blood products, tissues, chemicals andgene technology.
  8. 8. Regulators’ perspectives - FDAMission:• CDRH promotes and protects thehealth of the public by ensuring thesafety and effectiveness ofmedical devices and the safety ofradiological products.Vision:• Ensuring the health of the publicthroughout the "Total Product LifeCycle - its everyones business."
  9. 9. Regulators’ perspectives:PMDA, JapanPMDA continues to improve the public healthand safety of our nation by reviewingapplications for marketing approval ofpharmaceuticals and medical devices,conducting safety measures, and providingrelief to people who have suffered fromadverse drug reactions.
  10. 10. Regulators’ perspectives:EU“Providing access to the best medicaltechnology and devices, that meet the higheststandards of safety and improve the qualityof life, is a key objective of the Commissionpolicy towards European citizens”.Commissioner Erkki Liikanen
  11. 11. Requirements HierarchyLAWSREGULATIONSSTANDARDSGUIDANCE DOCUMENTS
  12. 12. Framework of Regulatory ControlsRegulatory AuditQuality Management System -PremarketClassification - Conformity AssessmentEssential PrinciplesStandardsDevice SpecificationRegistrationRisk ManagementPostmarket SurveillanceConformity Assessment (continued)Adverse Event ReportingComplaint ManagementDesign ControlDesign verification and validationClinical EvidenceSTEDDeclaration of conformityListingMaintenance and ServiceCorrective and Preventive ActionsPostmarket clinical follow up
  13. 13. Classification determines extent ofregulatory controlFDATPDTUVTGAMHLWSFDAKFDA
  14. 14. Regulatory ControlsDevices are typically assigned to four risk classes (EU => I,IIa, IIb, III + AIMD)Device Risk Class
  15. 15. Classification determines extent ofregulatory controlAssessmentQuality ManagementSystemTechnicalClass A Class B Class C Class DNo Audit Audit Audit AuditNot Not usuallyDocumentationDeclaration ofConformity &Essential PrinciplesChecklistRequiredNormallynotrequestedrequired Reviewed in depthReview for Review for Review forcompliancecompliancecomplianceDevices are typically assigned to four risk classes(eg, EU I, IIa, IIb, III + AIMD)
  16. 16. Cochlear Implant SystemFDA EU Canada Australia Japan China GHTFIII AIMD IV AIMD IV III DIII IIIII IIb III IIb III II C510(k),510(k) IIa II IIa II BexemptI I I I I I A510(k),510(k)exemptImplantSpeech ProcessorProgramming SystemSoftwareAccessoriesSurgical tools
  17. 17. A Regulatory MapGHTFAHWPOther Regs
  18. 18. Global Regulatory Landscape
  19. 19. The World Map21CFR820 ISO13485ISO13485 +
  20. 20. Key Regulations for CochlearRegulations1. Therapeutic Goods (Medical Devices) Regulations 2002 (Statutory Rules 2002 No. 236), Therapeutic GoodsAdministration, Australia2. Uniform Recall Procedure for Therapeutic Goods 2004 edition (Australia)3. Food and Drug Administration, USA Title 21, Code of Federal RegulationsPart 820: Quality System Regulation.Part 11 Electronic Records, Electronic SignaturesPart 806 Medical Devices, Reports of Corrections and RemovalsPart 803 Medical Device ReportingPart 812 Investigational Device ExemptionsPart 814 Premarket Approval of Medical Devices4. MHLW (Ministry of Health, Labour, and Welfare, Japan) Ordinance no. 169 (revised GMP, Japan) based onPAL (Pharmaceutical Affairs Law, Japan) [Law No. 145, as of August 10, 1960; Law No. 87 as of July 26,2005]5. Active Implantable Medical Device Directive (AIMD) 90/385/EEC (including 2007 rev), Europe6. Medical Device Directive (MDD) 93/42/EEC (including 2007 rev), Europe7. Medical Device Regulations (SOR/98-282) 1998, Department of Justice, Canada8. Regulations for the Supervision and Administration of Medical Devices, State Food and Drug Administration(SFDA), China9. Medical Devices Regulation, KFDA. Korea Food and Drug Administration, Korea10. Medical Devices Regulation, Taiwan Department of Health DoH, Taiwan

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