CTHIn ForceLegislation
Therapeutic Goods (Medical Devices) Regulations 2002
8A.1Definitions
Start here
Get a plain-English read of 8A.1
Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Medical Devices) Regulations 2002.
#### 8A.1 Definitions
In this Part:
> charge year has the same meaning as in the Therapeutic Goods (Charges) Regulations 2018.
> transitional medical device means a medical device of a kind mentioned in column 1 of an item in the following table if:
(a) the medical device was, immediately before 25 November 2021, included in the Register and classified as a class of medical device mentioned in column 2 of the item; or
(b) on 25 November 2021:
(i) the medical device was the subject of a class of application mentioned in column 2 of the item for inclusion in the Register; and
(ii) the application had not been finally determined.
```html
<table cellspacing="0" cellpadding="0" style="width:411.1pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:400.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Transitional medical device</span></p></td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span></span></p></td><td style="width:180.7pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:152.3pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td></tr><tr><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:180.7pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Kind of medical device</span></p></td><td style="width:152.3pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Class of medical device or application</span></p></td></tr></thead><tbody><tr><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:180.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a medical device of a kind described in subclause</span><span> </span><span>3.4(4B) of Schedule</span><span> </span><span>2</span></p></td><td style="width:152.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>Class IIb</span></p></td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a medical device of a kind described in clause</span><span> </span><span>5.10 of Schedule</span><span> </span><span>2</span></p></td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>Class I or Class IIa</span></p></td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a medical device of a kind described in clause</span><span> </span><span>5.11 of Schedule</span><span> </span><span>2</span></p></td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>Class I, Class IIa or Class IIb</span></p></td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a medical device of a kind described in subclause</span><span> </span><span>4.2(4) of Schedule</span><span> </span><span>2</span></p></td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>Class IIa or Class IIb</span></p></td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a medical device of a kind described in subclause</span><span> </span><span>3.2(3A) of Schedule</span><span> </span><span>2</span></p></td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>Class IIa or Class IIb</span></p></td></tr></tbody></table>
```