Division 4.1AKeeping of records

Division 4.1A— Keeping of records

20 Compliance records

A compliance record is a record that must be kept under section 21.

21 Keeping of records—general requirements

(1) The supplier of a device must keep, for 5 years after the device has ceased to be supplied in Australia:

(a) the declaration of conformity relating to the device; and

(b) the description of the device; and

(c) for a category B device—the records mentioned in section 22; and

(d) for a device to which a compliance label is not applied because of section 19C—the records mentioned in subsection 19C(3).

(2) If an agent of a manufacturer or importer keeps records for the manufacturer or importer that must be kept under subsection (1), the agent must also keep a copy of its agency agreement with the manufacturer or importer for the same period as those records are kept.

(3) A compliance record:

(a) must be in English; and

(b) may be a copy of an original record; and

(c) may be kept in electronic form.

22 Records of testing for category B devices

For paragraph 21(1)(c), the records are:

(a) the report issued under section 16 showing that the device meets the applicable standard; and

(b) for a variant—a statement by the supplier that:

(i) identifies the device and its variant; and

(ii) describes the differences between the device and its variant; and

(iii) provides a technical rationale for the conformity of the variant; and

(iv) includes evidence that the electromagnetic radiation exposure in relation to the variant is not likely to exceed that of the device.