Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 5751–9453

Duration of determinations
4A.9 Procedure following decisions not to make determinations
Division 4A.3—Conditions on conformity assessment body determinations
Subdivision A—Automatic conditions on determinations
4A.10 Automatic conditions on determinations
4A.11 Conditions—requirements of Schedule 3AA
4A.12 Conditions—notifying Secretary and clients
4A.13 Conditions—entry and inspection
4A.14 Conditions—producing information and documents
4A.15 Conditions—reviews
4A.16 Conditions—record keeping
4A.17 Conditions—Australian conformity assessment body certificates
4A.18 Conditions—clients
Subdivision B—Conditions specified in conformity assessment body determinations
4A.19 Conditions specified in determinations
Division 4A.4—Suspension of conformity assessment body determinations
4A.20 Suspension of determinations
4A.21 Notice of proposed suspension
4A.22 Duration of suspension
4A.23 Revocation of suspension
4A.24 Powers of revocation of determinations unaffected
Division 4A.5—Revocation of conformity assessment body determinations
4A.25 Automatic revocation of determinations
4A.26 Immediate revocation of determinations
4A.27 Revocation of determinations after notice of proposed revocation
Division 4A.6—Variation of conformity assessment body determinations
4A.28 Imposing, varying or removing conditions
4A.29 Limiting determinations
4A.30 Notice of proposed variation
Division 4A.7—Australian conformity assessment body certificates
4A.31 Content of Australian conformity assessment body certificates
Part 5—Including medical devices in the Register
Division 5.1—Including medical devices in the Register
Subdivision A—Applications
5.2 Matters to be certified—period for obtaining information from manufacturer (Act s 41FD)
Subdivision C—Auditing of applications
5.3 Selecting applications for auditing (Act s 41FH)
Subdivision D—Miscellaneous—medical devices (priority applicant) determinations
5.4 Application of Subdivision
5.4A Application for medical devices (priority applicant) determination
5.4B Making of medical devices (priority applicant) determination
5.4C Period during which medical devices (priority applicant) determination is in force
5.4D Revocation of medical devices (priority applicant) determination
Division 5.2—Conditions
5.7 Conditions applying automatically—period for giving information about adverse events etc (Act s 41FN)
5.8 Conditions applying automatically—requirements in relation to information about kind of medical device (Act s 41FN)
5.8A Conditions applying automatically—giving of report about adverse events or occurrences (Act s 41FN)
5.9 Conditions applying automatically—storage and transport of medical devices (Act s 41FN)
5.10 Conditions applying automatically—record‑keeping (Act s 41FN)
5.11 Conditions applying automatically—reporting (Act s 41FN)
5.12 Conditions applying automatically—notification of information (Act s 41FN)
5.13 Conditions applying automatically—information about poisons (Act s 41FN)
Part 6—Suspension and cancellation from the Register
6.1 Period for revocation of suspension (Act s 41GD, s 63(2)(dd))
Part 6A—Disposal of unused emergency medical devices
6A.1 Disposal of unused emergency medical devices
Part 7—Exempting medical devices from inclusion in the Register
Division 7.1—Exempt devices
7.1 Exempt devices—general (Act s 41HA)
7.2 Exempt devices—use in life‑threatening cases (Act s 41HA)
Division 7.2—Exemptions for experimental uses
7.3 Conditions of approval—use of device by person to whom approval is given (Act s 41HB)
7.4 Powers of authorised persons in relation to medical devices being used in clinical trials
7.5 Conditions of approval—use of device by another person (Act s 41HB)
Division