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NOTIFICATION FORM: Clinical decision support software exemption
This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 . The exemption applies to medical devices that are clinical decision support software (CDSS) that meet all three of the following criteria: intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a... MoreCloses 25 December 2031 -
Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR
Transitioning devices This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. Complete this form if you are a sponsor or agent seeking to utilise TGA’s web publication service to provide market notifications to health care providers and/or end users as a result of your devices transitioning from the EU MDD to the EU MDR. ... MoreCloses 31 July 2029 -
Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR
This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. This tool will assist you to determine what actions you may or may not need to take as a result of changes to conformity assessment documents relevant to your medical devices as a result of the implementation of the European Union Medical Device Regulations (EU MDR). ... MoreCloses 31 July 2029 -
Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification
From 1 July 2023, sponsors may apply for an annual charge waiver or refund for eligible transitioning medical devices subject to reclassification. Background In accordance with the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 , certain categories of medical devices are required to be reclassified so they align, wherever possible with the changes introduced in European Union (EU) medical devices framework. Transitional... MoreCloses 30 June 2029 -
Notification form: Lapses in medical device conformity assessment certification
Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. Notifying the TGA of any lapse in certification is a legal requirement. Changes to the medical device directive (93/42/EEC) and the IVD Directive (98/79/EC) along with disruptions due to the... MoreCloses 22 July 2026 -
Form: Annual Reporting of Custom-made medical devices
Manufacturers and sponsors of custom-made medical devices must supply an annual report to the TGA, detailing all of the custom-made medical devices they have manufactured and/or supplied within the preceding 1 July - 30 June financial year. The report must be submitted by 1 October each year. The report to the TGA can be submitted using this form. Please note: This form is being hosted on a consultation platform, however it is not a consultation and information provided in the form... MoreCloses 1 October 2024
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