Division 2.3Compliance levels

Division 2.3—Compliance levels

12 Compliance levels

(1) Before a supplier applies a compliance label to a device, the supplier must comply with the compliance level for the device.

(1A) For the purposes of subsections 18(3), (4), (5) and (6), the supplier of a device must ensure that the device complies with the compliance level for the device.

(2) The compliance level for a device is:

(a) for a category A device—compliance level 1; and

(b) for a category B device for which the normal position of use is more than 20cm from the human body—compliance level 2; and

(c) for a category B device for which the normal position of use is not more than 20cm from the human body—compliance level 3.

13 Compliance level 1

To comply with compliance level 1, the supplier of a device must:

(a) prepare a description of the device; and

(b) make a declaration of conformity for the device in accordance with section 11.

Note Subsection 11(2) sets out the circumstances in which the requirement for a supplier of a device to make a declaration of conformity is taken to be satisfied by the overseas manufacturer of the device making the declaration.

14 Compliance level 2

To comply with compliance level 2, the supplier of a device must:

(a) comply with compliance level 1; and

(b) show conformity with the applicable standard by a report of the results of assessment under section 16.

15 Compliance level 3

To comply with compliance level 3, the supplier of a device must:

(a) comply with compliance level 1; and

(b) show conformity with the applicable standard by a report of the results of an assessment under section 16 by an accredited testing body.