Session B19: Regulatory updates from the TGA Medical Devices Branch - - PowerPoint PPT Presentation
Session B19: Regulatory updates from the TGA Medical Devices Branch Dr Elizabeth McGrath Director, Medical Devices Emerging Technologies Unit, Medical Devices Branch Mimi Chu-Gourlay Assistant Director, Medical Devices Reforms Unit, Medical
Dr Elizabeth McGrath Director, Medical Devices Emerging Technologies Unit, Medical Devices Branch Mimi Chu-Gourlay Assistant Director, Medical Devices Reforms Unit, Medical Devices Branch 7 August 2019
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The regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) framework, including in respect of the classification of medical devices and essential principles/requirements.
– Changes to some definitions and regulation of some products without a medical purpose – Reclassification of medical devices (not IVD) (7 consultations) – Unique Device Identification (UDI) System for medical devices (including IVDs)
– Proposed changes to the essential principles, conformity assessment procedures, requirements for devices used in clinical trials, classification
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in Australia (https://www.tga.gov.au/consultation/consultation-changes-number-definitions-and-scope-medical-device-regulatory-framework-australia) – Opened 7 January 2019 |Closed 18 February 2019
– Harmonise Australian legislation and regulation with definitions in the EU MD Regulation – Regulate some products without a medical purpose as medical devices
– 21 submissions received from a range of stakeholders (industry, consumer advocacy groups, professional bodies, and other government organisations) – Some questions raised about some groups of definitions from the EU MD Regulation – General support for regulation of products without a medical purpose, with strong support for regulation of decorative contact lenses and brain stimulation devices without a specific medical purpose – Some questions about regulation of products for beauty therapy (e.g. personal IPL devices)
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Consultations (https://www.tga.gov.au/medical-devices-ivds-closed-consultations-reviews)
– Active medical devices for therapy with diagnostic function
– Spinal implantable medical devices
– Medical devices used in direct contact with the heart, central circulatory or central nervous systems – Medical device classification for human cells, tissues and organs storage solutions and IVF media – Substances introduced into the body via a body orifice or applied to the skin – Active implantable medical devices and their accessories – Medical devices that administer medicines or biologicals by inhalation
Benefit Risk
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– 56 submissions received to the 7 consultations – Received from a range of stakeholders (industry, consumer advocacy groups, professional bodies, healthcare professionals and other government organisations) – Strong support to align the classification rules in Australia with the EU MD Regulations – Some questions raised on lack of clarity on the intent in some of the EU classification rules
stakeholders (e.g. spinal implantable medical devices, active implantable medical devices and their accessories)
proposals (e.g. about medical devices that are human cells, tissues and organs storage solutions and IVF media) – Some questions raised not directly relevant to the consultations
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(https://www.tga.gov.au/consultation/consultation-proposal-introduce-unique-device-identification-udi-system-medical- devices-australia)
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– Improved reporting forms for consumers and health professionals – reporting is easier with minimal information required – Reporting forms for sponsors changed to reflect changes in the database – future consultation regarding the Action Plan will impact the reporting forms
– More ARTG entries will be at the Class III level meaning more ‘Annual Reports’
– Periodic Safety Update Reporting (PSUR)
– PSUR – Exemption rules – Inspections – Mandatory reporting – Publishing decisions
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https://www.tga.gov.au/hubs/mmdr
https://www.tga.gov.au/tga-consultations-email-list
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