Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 9220–12547

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 7.3—Exemptions for medical practitioners
7.6 Classes of medical practitioners and recipients (Act s 41HC)
7.7 Circumstances for supply of device under authority (Act s 41HC)
7.8 Information to be notified in relation to supply of certain medical devices
Part 8—Obtaining information
8.1A Matters for which information and documents can be requested
8.1 Notice period (Act s 41JA)
Part 8A—Waiver and refund of charges
8A.1 Definitions
8A.2 Waiver of charges in relation to transitional medical devices
8A.3 Refund of certain charges in relation to transitional medical devices
Part 9—Fees
Division 9.1—Fees
9.1 Fees
Division 9.1A—Reduced fee for consent to import, supply or export implantable medical devices—information requirements
9.1AA Working out the reduced fee
Division 9.2—Conformity assessment body determination assessment fees
9.1A Purposes of this Division
9.1B Conformity assessment body determination assessment fees
9.1C Conformity assessment body determination assessment fees—abridged assessment
9.1D Payment of conformity assessment body determination assessment fees by instalments
9.1E Recovery of conformity assessment body determination assessment fees
9.1F Refund of conformity assessment body determination assessment fees if applications withdrawn
Division 9.3—Assessment fees and reductions or refunds of fees connected with applications for conformity assessment certificates
9.2 Application audit assessment fee (Act ss 41LA, 41LB)
9.3 Conformity assessment fee (Act ss 41LA, 41LB)
9.5 Payment of assessment fee by instalments (Act s 41LC)
9.6 Reduction of assessment fees
9.7 Reduction of assessment fees—abridged assessment
9.8 Refund of fees—kinds of medical devices covered by former regulation 4.1
Division 9.4—Other refunds or waivers of fees
9.9 Other refunds or waivers of fees
Part 10—Miscellaneous
10.1 Authorised persons
10.2 Information about sponsor
10.3 Custom‑made medical devices—information about manufacturer
10.3A Custom‑made medical devices—information about supplies
10.4 Offences—period for notifying adverse events (Act s 41MP)
10.4AA Civil penalty—period for notifying adverse events
10.4A Secretary may maintain a system to enhance safe and effective use of particular medical devices
10.5 Delegation—powers and functions under these Regulations
10.6 Delegation—powers under paragraph 41HB(1)(d) of the Act
10.6A Delegation of Secretary's powers under section 41HD of the Act
10.6B Forms or manners—software requirements
10.7 Review of decisions
Part 11—Transitional provisions
Division 11.1—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1)
Subdivision A—Preliminary
11.1 Interpretation
11.2 Application of 2010 Amendment Regulations
Subdivision B—General provisions relating to transitional devices
11.3 Application of this Subdivision
11.4 Transitional devices exempted from requirement to be included in the Register
11.5 Essential principles for transitional devices
Subdivision C—Listed or registered transitional devices and exempt transitional devices
11.6 Application of