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 Devices Branch 7 August 2019
Overview - Part 1 • Review of Medicines and Medical Devices Regulation (MMDR) • Proposed changes to some definitions and regulation of some products without a medical purpose • Reclassification of medical devices (not IVD) • Unique Device Identification (UDI) System • Post-market monitoring 1
Review of Medicines and Medical Devices Regulation (MMDR) • Government accepted Recommendation 20: 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. • Consultations closed: – 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) • Consultations to be published: – Proposed changes to the essential principles, conformity assessment procedures, requirements for devices used in clinical trials, classification of devices containing nanomaterials 2
Changes to some definitions and regulation of some products without a medical purpose • Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework 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 • Proposal: – Harmonise Australian legislation and regulation with definitions in the EU MD Regulation – Regulate some products without a medical purpose as medical devices • Submissions: – 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) 3
Reclassification of medical devices (not IVD) Consultations (https://www.tga.gov.au/medical-devices-ivds-closed-consultations-reviews) • Opened: 7 January 2019 | Closed: 18 February 2019 – Active medical devices for therapy with diagnostic function Benefit • Opened: 11 February 2019 | Closed: 31 March 2019 – Spinal implantable medical devices Risk • Opened: 6 March 2019 | Closed: 29 April 2019 – 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 4
Reclassification of medical devices (not IVD) continued… • Submissions: – 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 TGA has undertook further targeted discussions with some of the relevant stakeholders (e.g. spinal implantable medical devices, active implantable medical devices and their accessories) TGA intends to engage further with relevant stakeholders regarding some other 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 5
Unique Device Identification (UDI) System for medical devices (including IVDs) Consultation • Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia (https://www.tga.gov.au/consultation/consultation-proposal-introduce-unique-device-identification-udi-system-medical- devices-australia) – Opened 7 January 2019 | Closed 18 February 2019 – UDI System is intended to provide a single, globally harmonised system for identification of medical devices. It is intended to be used to uniquely identify medical devices through their distribution and use. 6
Unique Device Identification (UDI) System for medical devices (including IVDs) • Submissions: − 49 submissions received from a range of stakeholders (industry, healthcare organisations, consumer advocacy groups, research institutions, and other government organisations) − Strong support for the introduction of the UDI System and establishment of the UDI database (AusUDID) − Some issues raised related to UDI labelling requirements, AusUDID requirements, responsibilities for entering data into the AusUDID • If a decision is made to introduce the UDI System, open and targeted consultations will be considered to engage different stakeholders’ groups through the supply chain 7
Post-market monitoring • Updating the adverse event database – 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 • Classification changes will impact on the reporting requirements from sponsors – More ARTG entries will be at the Class III level meaning more ‘Annual Reports’ • Aligning with the EU and other regulatory agencies – Periodic Safety Update Reporting (PSUR) • Consultation – PSUR – Exemption rules – Inspections – Mandatory reporting – Publishing decisions 8
Further information • Medicines and Medical Devices Regulation (MMDR) Review hub: https://www.tga.gov.au/hubs/mmdr • Subscribe to TGA’s consultations email list: https://www.tga.gov.au/tga-consultations-email-list • Contact the TGA Medical Devices Branch: devices@tga.gov.au ph: 1800 141 1444 • Contact the TGA Device Reforms Unit: devicereforms@tga.gov.au 9
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