Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 27618–30894

of production quality management system
4.4 Requirements of production quality management system
4.5 Changes to production quality management system
4.6 Information to be given to authorised person
4.7 Declaration of conformity
4.8 Records
Part 5—Product quality assurance procedures
5.1 Overview
5.2 References to kinds of medical devices
5.3 Implementation and assessment of product quality management system
5.4 Requirements of product quality management system
5.5 Changes to product quality management system or kinds of medical device
5.6 Information to be given to authorised person
5.7 Declaration of conformity
5.8 Records
Part 6—Declaration of conformity (not requiring assessment by Secretary) procedures
6.1 Overview
6.2 References to kinds of medical devices
6.3 Implementation
6.4 Required technical documentation
6.5 Post‑marketing system
6.6 Declaration of conformity
6.7 Records
Part 6A—Procedures applying to Class 1, 2 and 3 in‑house IVD medical devices
6A.1 Overview
6A.2 Procedures
6A.3 Information to be given to the Secretary
6A.4 Post‑marketing system
Part 6B—Procedures applying to Class 4 in‑house IVD medical devices
6B.1 Overview
6B.2 References to kinds of medical devices
6B.3 Procedures
6B.4 Required technical documentation
6B.5 Post‑marketing system
6B.6 Declaration of conformity
6B.7 Records
6B.8 Notification of certain Class 4 in‑house IVD medical devices being manufactured
Part 7—Procedures for medical devices used for a special purpose
7.1 Overview
7.2 Custom‑made medical devices
7.5 System or procedure packs
7.6 Records
Part 8—Clinical evaluation procedures
8.1 Overview
8.2 References to kinds of medical devices
8.3 Obtaining clinical data
8.4 Clinical investigation data
8.5 Literature review
8.6 Evaluation of clinical data
Schedule 3AA—Requirements for Australian conformity assessment bodies
1 Purpose of this Schedule
2 EU Regulations
3 Modifications of EU Regulations—general
4 Additional requirements
5 Additional modifications of EU medical devices regulations
6 Modifications of EU IVD regulations
7 Expressions used in modifications
Schedule 3A—Disposal of unused emergency medical devices
1 Early end of exemption—notice of medical devices held
2 End of exemption period—notice of medical devices held
3 Storage and disposal of unused emergency medical devices
4 Direction for disposal of unused emergency medical devices
5 Relocation of unused emergency medical devices
6 Disposal of unused emergency medical devices—destruction
7 Disposal of unused emergency medical devices—export
8 Disposal of unused emergency medical devices—supply
9 Owner to be paid for medical devices supplied
10 Records about unused emergency medical devices
11 Failure to comply with this Schedule
Schedule 4—Exempt devices
Part 1—Exempt devices—general
Part 2—Exempt devices—exemption subject to conditions
Schedule 5—Fees
Part 1—General
Part 2—Additional fees
2.1 Supplementary assessment
2.2 Costs of testing
     Dictionary
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history

Part 1—Preliminary

1.1  Name of Regulations
  These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.

1.3  Definitions—the dictionary etc
 (1) The dictionary at