Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p7
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 18866–22186

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 Definitions
11.75 Exemption for certain prescription spectacle lenses
11.76 Auditing of applications
11.77 Reclassification of medical devices
Division 11.21—Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024
11.78 Application provision—application audit assessment fees
Division 11.22—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024
11.79 Definitions
11.80 Application of amendments
11.81 Transitional vaping devices—exemption from Division 3 of Part 4‑11 of the Act
Division 11.23—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024
11.82 Definitions
11.83 Exempt therapeutic goods
11.84 Notices, statements and determinations
Schedule 1—Essential principles
Part 1—General principles
1 Use of medical devices not to compromise health and safety
2 Design and construction of medical devices to conform with safety principles
3 Medical devices to be suitable for intended purpose
4 Long‑term safety
5 Medical devices not to be adversely affected by transport or storage
6 Benefits of medical devices to outweigh any undesirable effects
Part 2—Principles about design and construction
7 Chemical, physical and biological properties
7.1 Choice of materials
7.2 Minimisation of risks associated with contaminants and residues
7.3 Ability to be used safely with materials etc
7.4 Verification of incorporated substance
7.5 Minimisation of risks associated with leaching substances
7.6 Minimisation of risks associated with ingress or egress of substances
7.7 Minimisation of risks associated with nanomaterials
8 Infection and microbial contamination
8.1 Minimisation of risk of infection and contamination
8.2 Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances
8.3 Medical devices to be supplied in a sterile state
8.4 Medical devices to be supplied in a non‑sterile state
8.5 Distinction between medical devices supplied in sterile and non‑sterile state
9 Construction and environmental properties
9.1 Medical devices intended to be used in combination with other devices or equipment
9.2 Minimisation of risks associated with use of medical devices
10 Medical devices with a measuring function
11 Protection against radiation
11.1 Minimisation of exposure to radiation
11.2 Medical devices intended to emit radiation
11.3 Minimisation of exposure to unintended radiation
11.4 Operating instructions
11.5 Medical devices intended to emit ionising radiation—additional requirements
12 Medical devices connected to or equipped with an energy source
12.1 Programmed or programmable medical device or software that is a medical device
12.2 Safety dependent on internal power supply
12.3 Safety dependent on external power supply
12.4 Medical devices intended to monitor clinical parameters
12.5 Minimisation of risk