The document discusses reforms to the regulation of medical devices in Australia, highlighted by the government's acceptance of 56 out of 58 recommendations from a comprehensive review. Key initiatives include the establishment of conformity assessment bodies, an expedited review process for novel devices, alignment with European regulations, and enhanced post-market monitoring systems. Upcoming legislative changes and consultations are planned to implement these reforms by January 2018.

1. Spotlight on Medical Device MMDR Reforms
Dr Cheryl McRae
Assistant Secretary
Medical Devices Branch, TGA
2017 ARCS Annual Conference
August, 2017

2. Expert Panel Review (MMDR)
• Two reports released during 2015
– Medicines and Devices
– Complementary medicines and Advertising
• Review included discussion papers, submissions and interviews,
followed by stakeholder workshops and other meetings
• Department considered feedback and advised Minister, who took
preferred position to Cabinet
• Government intent released in May 2016 budget - full response
released on 15 September 2016
– Government accepted 56 of the 58 Recommendations
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3. Overarching principles for regulation
As endorsed by Government
• The Australian Government retains responsibility for approving
the inclusion of therapeutic goods in the ARTG
– Rather than automatically accepting international approvals
– However need to make much greater use of overseas evaluations
• Need to introduce greater flexibility in approval pathways
• TGA could more appropriately align level of regulation with the
actual risk posed by the products in certain areas
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4. MMDR medical device projects
• Key projects
• Designation of conformity assessment bodies in Australia
• Expedited review process for certain ‘novel’ devices
• Use of approvals from comparable overseas regulators
• Harmonisation with the European Union
• Strengthening of post market monitoring
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5. MMDR medical device projects
Other relevant projects
• Further reviews - including review of the range of low-risk devices included in the ARTG
• TGA advisory committees – includes new Advisory Committee on Medical Devices
Related projects
• Simplified and more effective regulation of advertising
• Streamlined regulation of Patient-Specific Access
• SME regulatory assistance
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6. Designation of conformity assessment bodies
Implementation scheduled for January 2018
• Legislative change in progress:
– Therapeutic Goods Amendment (2016 Measures No 1) Act 2017) – Royal Assent 19 June 2017
– Further legislative change in a further Bill for passage in the Spring 2017 sittings
– Regulations also required
• Key processes being designed:
– TGA as designating authority - Roles and responsibilities, composition, structure, cost recovery and
competitive neutrality
– Conformity assessment bodies - Roles and responsibilities, requirements and market potential
– Designation process - Framework and criteria
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7. Designation of conformity assessment bodies
Implementation will be complex
• Few commercial conformity assessment bodies
currently exist in Australia.
• Is the market big enough to justify setting up Australian
notified bodies?
• Cost and logistics for TGA in being a designating
authority as well as a conformity assessment body.
• Flow on impacts of competitive neutrality requirements
for TGA conformity assessment.
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8. Expedited review process - certain ‘novel’ devices
Implementation scheduled for January 2018
• Legislation in place (regulations also required)
• ‘Front of queue’ approach with normal assessment requirements
– Must still comply with EPs, conformity assessment procedures, etc.
– Compliance with Clinical Evidence Guidelines critical for fast assessment
• Reason for accelerated assessment would be based on health outcomes:
– prevents, diagnoses or treats a life threatening or seriously debilitating disease or condition
– addresses an unmet clinical need
– breakthrough technology
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9. Expedited review process - certain ‘novel’ devices
Implementation will be complex
• Need to define strict criteria to warrant expedited evaluation
– Will be similar, but not identical, to US FDA criteria
 include devices that can ‘prevent diseases and conditions’
 include ‘seriously debilitating’ rather than ‘irreversibly debilitating’ conditions
• Designation process will be under 6 weeks
– eligible sponsor must submit application within 3 months
• Impacts on other assessments need to be managed
• Rejection by a foreign regulator and failure to continue meeting
eligibility criteria can result in loss of status
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10. Comparable overseas regulators
Implementation scheduled for January 2018
• Legislation and regulations required
– Legislative change in MMDR Bill for passage in the Spring 2017 sittings
• Consultation closed 30 June 2017
– Submissions being considered (17 received)
• Proposed criteria:
– Scope
– Operational alignment
– IMDRF member
– Life cycle approach
– Communication and cooperation
– Expertise
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11. Comparable overseas regulators
Implementation will be complex
• International device regulations different to Australia
• Comparable overseas regulators will need to be identified
• Regulations undergoing significant change in Europe
• Sponsors need to provide submissions and evaluation
reports to TGA
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12. Harmonisation with Europe
New European regulations came into effect from 25 May 2017
• MMDR Recommendation 20 accepted by Government:
“The regulation of medical devices by the Australian NRA is, wherever possible, aligned with the European
Union framework…Should the Australian NRA seek to apply specific requirements, there must be a clear
rationale to do so.”
• Consultation has recently commenced on two specific aspects (closes 25 August 2017):
– Up-classification of surgical mesh from Class IIb to Class III
– Requirement for patient medical device ID cards (patient implant cards)
 Aim to be in place by end of 2017 (with transition aligned with Europe)
• Further consultations on harmonisation with Europe will be released in 2018
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13. Post market monitoring recommendations
• Better integration and timely analysis of available datasets
• Electronic reporting of adverse events
• Enhanced information-sharing with overseas regulators
• Implementation of registries for all high risk implantable devices
Accepted by Government
Deferred
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14. Post market monitoring
Enhanced Post Market Monitoring and Analytics (EPMMA)
• TGA has embarked on a project aimed at establishing
enhanced post market monitoring and analytics
– has already delivered enhanced analytics for medical devices
• The next stages in the project will deliver:
– electronic data interchange (EDI) for reporting of medical device incident
reports
– improved TGA adverse event report management systems (AEMS).
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15. Post market monitoring
Electronic Data Interchange (EDI)
• Currently, details of adverse events and incidents are
manually entered in an online TGA form (via the TGA’s
Business Services portal).
• EDI will enable sponsors (and other users) to submit the
required information directly from their own information
management / investigation systems.
• Expected to be launched early 2018.
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16. Low risk product review
Consultation closed May 2017 – over 1000 submissions
• Part of review includes Class I medical devices:
– does not recommend changing the current Australian classification system for
medical devices
– no specific products have been singled out under this review
• Proposed next steps
– Systematic review of ARTG to identify non therapeutic goods
– Engage with States and Territories Health department procurement branches
– Update the Excluded Goods Order
– Review the Class I medical device ARTG entry process
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17. Questions?
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