(c) target emerging Not addressed Instrument for Not addressed - risks additional options mandatory proposed are audits allows static risk management over time (d) promoting Not addressed Minimises Duplication of alignment of duplication of conformity international regulatory assessment for medical device activity AIMD and Class regulation III implantable devices * Note: the more ticks in a cell the greater the effect of the option on the key issue or objective. Crosses indicate not effect. Based on the above table, and the relative cosy of the options as outlined in the Costs and benefits section above, Option 2 is recommended as the appropriate response. <<< This conclusion section is included as a draft for consultation it is expected it – will be expanded and revised based on feedback provide through consultation >>> Attachments Attachment A: Regulation of medical devices in Australia Under the Therapeutic Goods Act 1989, medical devices must be included on the Australian Register of Therapeutic Goods (ARTG) prior to supply in Australia unless exempt from that requirement. In order to be included on the ARTG, devices must have the necessary conformity assessment certification to ensure they are of acceptable safety and quality, and perform as intended. An application must be made to the TGA to include the device on the ARTG, supported by the appropriate conformity assessment certification. The level of assessment conducted by the TGA at the point of application for ARTG inclusion depends on the following: the risk classification of the device, against the following range: Class I: low risk; I - supplied sterile and/or incorporating a measuring function: low–medium risk; Class IIa: low–medium risk; Class IIb: medium–high risk;
(c) target emerging risks Not addressed Instrument for additional mandatory audits allows risk management over time Not addressed - options proposed are static (d) promoting alignment of international medical device regulation Not addressed Minimises duplication of regulatory activity Duplication of conformity assessment for AIMD and Class III implantable devices * Note: the more ticks in a cell the greater the effect of the option on the key issue or objective. Crosses indicate not effect. Based on the above table, and the relative cosy of the options as outlined in the Costs and benefits section above, Option 2 is recommended as the appropriate response. <<< This conclusion section is included as a draft for consultation – it is expected it will be expanded and revised based on feedback provide through consultation >>> Attachments Attachment A: Regulation of medical devices in Australia Under the Therapeutic Goods Act 1989, medical devices must be included on the Australian Register of Therapeutic Goods (ARTG) prior to supply in Australia unless exempt from that requirement. In order to be included on the ARTG, devices must have the necessary conformity assessment certification to ensure they are of acceptable safety and quality, and perform as intended. An application must be made to the TGA to include the device on the ARTG, supported by the appropriate conformity assessment certification. The level of assessment conducted by the TGA at the point of application for ARTG inclusion depends on the following: the risk classification of the device, against the following range: Class I: low risk; I - supplied sterile and/or incorporating a measuring function: low–medium risk; Class IIa: low–medium risk; Class IIb: medium–high risk;