Spotlight on Medical Device MMDR Reforms Dr Cheryl McRae Assistant - - PowerPoint PPT Presentation

Spotlight on Medical Device MMDR Reforms

Dr Cheryl McRae Assistant Secretary Medical Devices Branch, TGA 2017 ARCS Annual Conference August, 2017

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

Spotlight on Medical Device MMDR Reforms 1

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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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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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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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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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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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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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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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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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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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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Post market monitoring recommendations

Accepted by Government

• Better integration and timely analysis of available datasets
• Electronic reporting of adverse events
• Enhanced information-sharing with overseas regulators

Deferred

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• Implementation of registries for all high risk implantable devices

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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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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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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Questions?

16