215 results
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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 -
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 -
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 31 July 2035 -
Form: Confirmation of M2M HL7 SPL testing completion
This form is for medical device sponsors, manufacturers, or agents. It lets you advise the Therapeutic Goods Administration (TGA) that you confirm that your organisation has completed M2M HL7 SPL testing in accordance with the validation procedure in the M2M HL7 SPL – User Guide – AusUDID and is ready to submit UDI records to the AusUDID Production environment, using HL7 SPL. In particular, the confirmation is designed to reflect that you have undertaken all necessary... MoreCloses 1 January 2100 -
Form: Intent to submit to AusUDID using M2M HL7 SPL
This form is for medical device sponsors, manufacturers, agents or third party data providers. It lets you advise the Therapeutic Goods Administration (TGA) that you plan to submit data to the Australian Unique Device Identification Database (AusUDID) using the M2M HL7 SPL submission method. Important information: You cannot submit data to the AusUDID using M2M HL7 SPL until this form is completed. For more information on using the M2M... MoreCloses 1 January 2100
215 results.
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