Australian Once the manufacturer has obtained conformity assessment evidence, Manufacturer Declaration of they must make an Australian DoC Conformity The DoC declares that the device complies with: (DoC) the applicable provisions of the Essential Principles the classification rules an appropriate conformity assessment procedure if requested, the TGA must be provided with a copy of the DoC the DoC must be maintained and updated when appropriate Ongoing Maintain appropriate records, including: Manufacturer conformity technical documentation assessment responsibilities evidence that an appropriate conformity assessment procedure has been applied the Australian Declaration of Conformity details of any systematic reviews undertaken details of any changes to the device and/or quality management system implement appropriate means to apply any necessary corrective action in relation to the design or production of a device notify the TGA and/or the sponsor as soon as practicable becoming aware of information relating to any malfunction or adverse event systematically review information gained the device is supplied in Australia Please note: for more information on these requirements please see Section 22. Post-market vigilance and monitoring requirements. apply for re-certification prior to the expiry of existing conformity assessment evidence The classification of a medical device determines the conformity assessment procedures a manufacturer can choose to ensure that the device is adequately assessed. Higher classification devices must undergo more stringent conformity assessment procedures than classification devices. The conformity assessment procedures have been modelled on those developed by the Global Harmonization Task Force (GHTF), an international forum that was established to achieve greater uniformity between national medical device regulatory systems. The GHTF principles of conformity assessment are also closely aligned with the relevant EU Directives. Although the Australian and EU conformity assessment procedures are similar, there are some important differences manufacturers must be aware of and accommodate, before completing an Australian Declaration of Conformity. For more information please see . The Australian Government also has international agreements in place with other countries. For more information on these agreements please see . The conformity assessment evidence to be registered with the TGA for all medical devices, except Class I non-measuring and non-sterile medical devices.
Australian Declaration of Conformity (DoC) Once the manufacturer has obtained conformity assessment evidence, they must make an Australian DoC The DoC declares that the device complies with: the applicable provisions of the Essential Principles the classification rules an appropriate conformity assessment procedure if requested, the TGA must be provided with a copy of the DoC the DoC must be maintained and updated when appropriate Manufacturer Ongoing conformity assessment responsibilities Maintain appropriate records, including: technical documentation evidence that an appropriate conformity assessment procedure has been applied the Australian Declaration of Conformity details of any systematic reviews undertaken details of any changes to the device and/or quality management system implement appropriate means to apply any necessary corrective action in relation to the design or production of a device notify the TGA and/or the sponsor as soon as practicable becoming aware of information relating to any malfunction or adverse event systematically review information gained the device is supplied in Australia Please note: for more information on these requirements please see Section 22. Post-market vigilance and monitoring requirements. apply for re-certification prior to the expiry of existing conformity assessment evidence Manufacturer The classification of a medical device determines the conformity assessment procedures a manufacturer can choose to ensure that the device is adequately assessed. Higher classification devices must undergo more stringent conformity assessment procedures than classification devices. The conformity assessment procedures have been modelled on those developed by the Global Harmonization Task Force (GHTF), an international forum that was established to achieve greater uniformity between national medical device regulatory systems. The GHTF principles of conformity assessment are also closely aligned with the relevant EU Directives. Although the Australian and EU conformity assessment procedures are similar, there are some important differences manufacturers must be aware of and accommodate, before completing an Australian Declaration of Conformity. For more information please see . The Australian Government also has international agreements in place with other countries. For more information on these agreements please see . The conformity assessment evidence to be registered with the TGA for all medical devices, except Class I non-measuring and non-sterile medical devices.