Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1--Reclassification of medical devices                                                                           2

Part 1--Spinal implantable medical devices                                                                                2

Therapeutic Goods (Medical Devices) Regulations 2002                                                             2

Part 2--Active implantable medical devices                                                                               3

Therapeutic Goods (Medical Devices) Regulations 2002                                                             3

Part 3--Medical devices that administer medicines or biologicals by inhalation     5

Therapeutic Goods (Medical Devices) Regulations 2002                                                             5

Part 4--Medical devices that are substances for introduction into the body             6

Therapeutic Goods (Medical Devices) Regulations 2002                                                             6

Part 5--Active medical devices for therapy                                                                                7

Therapeutic Goods (Medical Devices) Regulations 2002                                                             7

Part 6--Medical devices in direct contact with the heart etc.                                            8

Therapeutic Goods (Medical Devices) Regulations 2002                                                             8

Part 7--Amendments relating to charges                                                                                      9

Therapeutic Goods (Charges) Regulations 2018                                                                            9

Schedule 2--Programmed or programmable medical device or software that is a medical device         10

Part 1--Classification rules                                                                                                                10

Therapeutic Goods (Medical Devices) Regulations 2002                                                           10

Part 2--Essential principles                                                                                                                13

Therapeutic Goods (Medical Devices) Regulations 2002                                                           13

Schedule 3--Personalised medical devices                                                                                      15

Part 1--Definitions                                                                                                                                 15

Therapeutic Goods (Medical Devices) Regulations 2002                                                           15

Part 2--Reports                                                                                                                                        17

Therapeutic Goods (Medical Devices) Regulations 2002                                                           17

Part 3--Conformity assessment procedures                                                                              18

Therapeutic Goods (Medical Devices) Regulations 2002                                                           18

Part 4--Exemptions                                                                                                                               19

Therapeutic Goods (Medical Devices) Regulations 2002                                                           19

Part 5--Classification rules                                                                                                                22

Therapeutic Goods (Medical Devices) Regulations 2002                                                           22

Part 6--Essential principles                                                                                                                23

Therapeutic Goods (Medical Devices) Regulations 2002                                                           23

Schedule 4--IVD companion diagnostics                                                                                        24

Therapeutic Goods (Medical Devices) Regulations 2002                                                           24

Schedule 5--Faecal microbiota transplant products                                                                25

Therapeutic Goods Regulations 1990                                                                                             25

Schedule 6--Consumer medicine information documents                                                   26

Therapeutic Goods Regulations 1990                                                                                             26

Schedule 7--Handling and testing of samples                                                                              28

Therapeutic Goods Regulations 1990                                                                                             28

Schedule 8--Fee waivers for certain requests relating to prescription opioids        33

Therapeutic Goods Regulations 1990                                                                                             33

Schedule 9--Other amendments                                                                                                           34

Part 1--Fee waiver for requests to vary product information for medicine              34

Therapeutic Goods Regulations 1990                                                                                             34

Part 2--Clinical trials                                                                                                                             35

Therapeutic Goods Regulations 1990                                                                                             35

Part 3--Nappy rash products                                                                                                            36

Therapeutic Goods Regulations 1990                                                                                             36

Part 4--Other amendments                                                                                                                37

Therapeutic Goods Regulations 1990                                                                                             37

Schedule 10--Application, saving and transitional provisions                                           38

Therapeutic Goods (Medical Devices) Regulations 2002                                                           38

Therapeutic Goods Regulations 1990                                                                                             47

 

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