Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p6
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 15619–19199

Measures No. 3) Regulations 2018
11.37 Application of table item 1.5 in Part 1 of Schedule 5
Division 11.10—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019
Subdivision A—Definitions
11.38 Definitions
Subdivision B—Reclassification of medical devices
11.39 Definitions
11.40 Transitional medical devices—application of amendments
11.41 Transitional medical devices—Secretary must be notified of unique product identifiers of devices supplied under pre‑commencement entries
11.42 Transitional medical devices—selecting applications for auditing
11.43 Waiver of certain application fees
Subdivision C—Programmed or programmable medical device or software that is a medical device
11.44 Definitions
11.45 Programmed or programmable medical device or software that is a medical device—classification rules
11.46 Secretary must be notified in relation to a transitional kind of medical device
11.47 Programmed or programmable medical device or software that is a medical device—essential principles
Subdivision D—Personalised medical devices
11.48 Definitions
11.49 Personalised medical devices—reports
11.50 Personalised medical devices—conformity assessment procedures
11.51 Personalised medical devices—exemptions
11.52 Personalised medical devices—classification rules
11.53 Secretary must be notified in relation to a transitional kind of medical device
Subdivision E—IVD companion diagnostics
11.54 IVD companion diagnostics
Division 11.11—Application provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020
11.55 System or procedure packs
11.56 Period for notifying adverse events
11.57 Class 4 in‑house IVD medical devices
Division 11.12—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021
11.58 Application provisions
Division 11.13—Application, saving and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021
11.59 System or procedure packs
11.60 Reports about adverse events or occurrences for medical devices
11.61 Patient implant cards and patient information leaflets
11.62 Medical devices assembled or adapted at point of care
11.63 Patient‑matched medical devices
11.64 Surgical loan kits
11.66 Surgical mesh
Division 11.14—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021
11.67 Patient implant cards and patient information leaflets
Division 11.15—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022
11.68 Fee for application for consent of Secretary
Division 11.16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022
11.69 Fee for application for consent of Secretary
11.70 Exempt medical devices
Division 11.17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023
11.71 Clinical trials
Division 11.18—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023
11.72 Clinical trials
Division 11.19—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023
11.73 Application of amendments
Division 11.20—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024
11.74