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35 result(s) found, displaying 1 to 25
- PublicationsAustralian Dental Sector Working Group, Meeting statement, Meeting 4, 31 March 2022A meeting statement from the fourth meeting of the Dental Sector Working Group is now available.
- PublicationsSummary and outcomes: review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in AustraliaSummary and outcomes of recent consultation on IVD self-tests.
- PublicationsTGA-NATA MoU relating to the regulation of in-house IVDsDescribers the interaction, role and responsibilities of the TGA and NATA in relation to the regulation of in-house IVDs
- PublicationsMedical devices reforms: Consumer Working Group meeting statement, Meeting 1, 19 November 2019Details about meeting 1 for the medical device reform consumer working group held in 2019.
- PublicationsMedical devices reforms: Consumer Working Group meeting statement, Meeting 2, 20 February 2020Details about meeting 2 for the medical device reform consumer working group held in 2020.
- PublicationsMedical devices reforms: Consumer Working Group meeting statement, Meeting 3, 18 June 2020Details about meeting 3 for the medical device reform consumer working group held in 2020.
- PublicationsMedical devices reforms: Consumer Working Group meeting statement, Meeting 4, 27 November 2020Details about meeting 4 for the medical device reform consumer working group held in 2020.
- PublicationsTherapeutic Goods (Medical Devices - Application Form for Priority Applicant Determinations) Approval 2020New legislative instrument
- PublicationsAustralian Dental Sector Working Group, Meeting statement, Meeting 1, 19 April 2021Details for meeting 1 of Australian Dental Sector Working Group held on 19 April 2021.
- PublicationsAustralian Dental Sector Working Group, Meeting statement, Meeting 2, 29 June 2021A meeting statement from the second meeting of the Dental Sector Working Group is now available.
- PublicationsMedical devices reforms: Consumer Working Group meeting statement, Meeting 5, 15 December 2021Meeting statement from meeting 5 of the MDCWG.
- PublicationsMedical devices reforms: Consumer Working Group meeting statement, Meeting 6, 25 February 2022Meeting statement from meeting 6 of the MDCWG.
- PublicationsAustralian Dental Sector Working Group, Meeting statement, Meeting 3, 27 August 2021A meeting statement from the third meeting of the Dental Sector Working Group is now available.
- PublicationsTherapeutic Goods (Goods that are not Therapeutic Devices) Order No. 1 of 1992Therapeutic Goods Order No. 1 of 1992.
- PublicationsTherapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2010Therapeutic Goods Order No. 1 of 2010.
- PublicationsGuidance for IVD sponsors - a roadmap to marketGuidance for IVD sponsors - a roadmap to market.
- PublicationsRegulation impact statement for reclassification of hip, knee and shoulder joint implantsThis statement guides decision making to help address concerns with joint replacement prostheses.
- PublicationsApplication audit (technical file review) of IVD medical device applicationsPrepare for a technical file review as part of your application to include an in vitro medical device in the Australian Register of Therapeutic Goods.
- PublicationsClassification of IVD medical devicesIVDs are classified according to the health risk that may arise from an incorrect result
- PublicationsTGA conformity assessment overview for in vitro diagnostic medical devices (IVDs)Information on conformity assessment of in vitro diagnostic medical devices (IVDs).
- PublicationsIncluding IVD medical devices in the ARTGUpdate to Including IVD medical devices in the ARTG
- PublicationsRegulatory requirements for in-house IVDsUpdated in-house IVD regulatory requirements guidance document now available
- PublicationsThe use of GMDN codes for IVD medical devices in AustraliaThe use Global Medical Device Nomenclature (GMDN) codes for in vitro diagnostic medical devices supplied in Australia.
- PublicationsGuidance on medical/surgical face masks and respirator standards - key performance aspectsGuidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing
- PublicationsUpdating an existing Class 1-3 in-house IVD notificationGuidance for sponsors seeking to update an existing Class 1-3 in-house IVD notification