Class III and AIMD Proposal A introduction of Option 2 Proposal A - new The initial proposal for TGA (i) – – implantable devices require Level 3 audit to assess Level 3 audit to assess conformity assessment for all a TGA conformity evidence of conformity evidence of conformity Class III implantable and AIMD assessment certificate to be (including new fee) (including new fee) medical devices has been issued replaced with the Level 3 audit proposal Expanding the Class IIb Proposal A expanded Option 2 Proposal A - Though not identical, this (ii) – – implantable devices to be targeting of mandatory audits expanded targeting of option is a direct progression selected for mandatory to all Class IIb implantable and mandatory audits for targeted from the 2010 proposal to auditing long term surgically invasive devices (new regulatory select Class IIb implantable medical devices. instrument proposed) devices for mandatory audit Proposal 2C The TGA will further develop these proposals in consultation Recognition of third party with stakeholders and provide assessment bodies advice to Government. (i) Confidence building for This option has been EU notified bodies overtaken by the update of the designated under the MRA MRA and confidence building is being progressed in that context (ii) Recognising Australian This option has been third party assessment overtaken by the proposed EU bodies notified reforms. Immediate issues are addressed by the Option 2, Proposal audit requirements.
(i) Class III and AIMD implantable devices require a TGA conformity assessment certificate to be issued 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) 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 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) 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 The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government. (i) Confidence building for EU notified bodies designated under the MRA This option has been overtaken by the update of the MRA and confidence building is being progressed in that context (ii) Recognising Australian third party assessment bodies This option has been overtaken by the proposed EU notified reforms. Immediate issues are addressed by the Option 2, Proposal audit requirements.
consult-ris-medical-devices-premarket-assessment-130510-1.docx