Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring

1. 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

2. 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
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3. 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

4. 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)
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5. 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
• Opened: 11 February 2019 | Closed: 31 March 2019
– Spinal implantable medical devices
• 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
Benefit
Risk
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6. 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
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7. 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.
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8. 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
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9. 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

10. 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
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