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Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

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Attachment A: Previous and current reform proposals

The following table maps the reform proposals in the 2010 and 2013 consultation processes, illustrating how these proposals have developed over this period.

Consultation Paper October 2010 TGA Blueprint Implementation Plan July 2012 Consultation Paper January 2013 RIS Exposure Draft
May 2013
RIS
June 2013
Notes

Proposal 1

Reclassification of joint replacement implants

Agreed Not applicable as implemented on 1 July 2012 Completed – joint replacement implants were reclassified from 1 July 2012.

Proposal 2A

Use of third party assessment bodies for all Australian medical device manufacturers

The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government.

Proposal C – Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower risk medical devices

(limited application to Class IIb and lower)

Option 2 - Proposal C - Abolition of requirement for TGA conformity assessment for Australian manufacturers

(applies to all classes of devices, as originally proposed in 2010 proposal)

Option 2 - Proposal C - Abolition of requirement for TGA conformity assessment for Australian manufacturers Unchanged from RIS exposure draft

Proposal 2B

Increasing pre market scrutiny for implantable medical devices

(i) Class III and AIMD implantable devices require a TGA conformity assessment certificate to be issued The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government. Proposal A – introduction of Level 3 audit to assess evidence of conformity (including new fee) Option 2 – Proposal A - new Level 3 audit to assess evidence of conformity (including new fee)

Option 2 – Proposal A - new Level 3 audit to assess evidence of conformity

Unchanged from RIS exposure draft

The initial proposal for TGA conformity assessment for all Class III implantable and AIMD medical devices has been replaced with the Level 3 audit proposal
(ii) Expanding the Class IIb implantable devices to be selected for mandatory auditing The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government. Proposal A – expanded targeting of mandatory audits to all Class IIb implantable and long term surgically invasive medical devices. Option 2 – Proposal A - expanded targeting of mandatory audits for targeted devices (new regulatory instrument proposed)

Option 2 – Proposal A - expanded targeting of mandatory audits for targeted devices

Unchanged from RIS exposure draft

Though not identical, this option is a direct progression from the 2010 proposal to select Class IIb implantable devices for mandatory audit

Proposal 2C

Recognition of third party assessment bodies

While not specifically addressed in this RIS, Option 2 Proposal A and Proposal C in this RIS provide for recognition of third party assessment bodies to proceed
(i) Confidence building for EU notified bodies designated under the MRA The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government. Proposal A - proposed where a European notified body has issued an MRA conformity assessment certificate and undertaken confidence building, the TGA would select the application for a Level 1 audit. Option 2 - Proposal A - the level of mandatory audit could be reduced below Level 3 if confidence building requirements satisfied.

Option 2 – Proposal A - the level of mandatory audit could be reduced below Level 3 if confidence building requirements satisfied.

Unchanged from RIS exposure draft.

This option has been overtaken by the update of the MRA and confidence building is being progressed in that context. Option 2 Proposal A provides a good basis for confidence building.
(ii) Recognising Australian third party assessment bodies The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government.

Option 2 Proposal C allows this to happen

(as to some extent does Option 2 Proposal A)

This option has been overtaken by the proposed EU notified reforms. Immediate issues are addressed by the Option 2, Proposal A-mandatory audit requirements.

Proposal 3

Amending the way in which a medical device is included in the ARTG and enhancing identification of approved devices

(i) Amend the way in which a kind of device is included on the ARTG (product name) The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government.

Option 2 Proposal C allows this to happen

(as to some extent does Option 2 Proposal A)

This option has been overtaken by the proposed EU notified reforms. Immediate issues are addressed by the Option 2, Proposal A-mandatory audit requirements.
(ii) Enhance the ability to identify devices that have been approved by the TGA for supply in Australia (including ARTG number on product labels, etc)

Not agreed.

Proposal not supported as other reforms will achieve this objective.

Following the 2010 consultation it was agreed that this proposal would not progress.

Proposal 4

Publication of device product information on the TGA website

The TGA will work with stakeholders to develop a proposal to provide product information for medical devices with implementation planned from 1 July 2014. Proposal B – Publication of TGA regulatory decisions Option 2 – Proposal B - Publication of TGA regulatory decisions

Option 2 – Proposal B - Publication of TGA regulatory decisions

Modified from RIS exposure draft to restrict publication of negative decisions to only those related to safety and/or efficacy

This option is addressed through Option 2 Proposal B

* At the time the TGA Blueprint was released in December 2011, the response for Proposals 2A, B and C was only noted, pending the outcome of the Senate Community Affairs Referenced Committee inquiry into "The regulatory standards for the approval of medical devices in Australia". The response for Proposal 2A, B and C at that time was: Noted. Linked to further recommendation in Senate Community Affairs Referenced Committee inquiry into "The regulatory standards for the approval of medical devices in Australia". By the time the Blueprint Implementation Plan the way forward on these issues had been clarified, and so this is included in the table above.

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