Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The Secretary may, in writing, impose requirements, relating to a kind of medical device, on a person if:
(a) any of the circumstances referred to in the second column of an item in the following table occur in relation to the kind of device; and
(b) the person is referred to in the third column of that item of the table.
Circumstances in which requirements may be imposed | ||
Item | Circumstance relating to a kind of medical device | Person subject to requirements |
1. | It is supplied while it is included in the Register, but the Secretary is satisfied that medical devices of that kind do not comply with the essential principles | The person in relation to whom it is included in the Register |
It is supplied while it is included in the Register, but the Secretary is satisfied that the conformity assessment procedures have not been applied to medical devices of that kind and that requirements, comparable to those procedures, have not been applied to medical devices of that kind | The person in relation to whom it is included in the Register | |
3. | It is supplied while: (a) medical devices of that kind are exempt devices; or (b) there is an approval under section 41HB relating to devices of that kind; or (c) there is an authority under section 41HC relating to devices of that kind; or (d) there is an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind; but the Secretary is satisfied that medical devices of that kind do not comply with the essential principles | The person supplying the kind of medical device |
It is supplied while: (a) medical devices of that kind are exempt devices; or (b) there is an approval under section 41HB relating to devices of that kind; or (c) there is an authority under section 41HC relating to devices of that kind; or (d) there is an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind; but the Secretary is satisfied that the conformity assessment procedures have not been applied to medical devices of that kind and that requirements, comparable to those procedures, have not been applied to medical devices of that kind | The person supplying the kind of medical device | |
It is supplied and the Secretary is satisfied that: (a) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--the supply contravenes one or more of those prohibitions; or (b) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--the supply contravenes one or more of those conditions | The person supplying the kind of medical device | |
5. | It is supplied while: (a) it is not included in the Register; and (aa) it is not covered by an exemption in force under section 41GS; and (b) it is not an exempt device; and (c) there is not an approval under section 41HB relating to devices of that kind; and (d) there is not an authority under section 41HC relating to devices of that kind; and (e) there is not an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind. | The person supplying the kind of medical device |
5A. | It is supplied while it is covered by an exemption in force under section 41GS, and the Secretary is satisfied that it is not fit to be used for its intended purpose | The person supplying the kind of medical device |
5B. | It is supplied while it is included in the Register, but it appears to the Secretary that the quality, safety or performance of medical devices of that kind is unacceptable | The person in relation to whom the kind of medical device is included in the Register |
6. | It has been suspended from the Register | The person in relation to whom it was included in the Register |
7. | Its entry has been cancelled from the Register | The person in relation to whom it was included in the Register |
8. | It is counterfeit goods (within the meaning of section 42E) | The person supplying the kind of medical device |
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within such reasonable period as is specified, to recall medical devices of that kind that have been distributed;
(b) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to medical devices of that kind;
(c) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:
(i) medical devices of that kind;
(ii) the circumstances referred to in paragraph (1)(a);
(d) to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of medical devices of that kind;
(e) to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom medical devices of that kind have been supplied.
(3) If the circumstances referred to in paragraph (1)(a) apply only to some medical devices of that kind, the Secretary may limit the imposition of the requirements to the medical devices of that kind to which those circumstances apply.
(4) A requirement to recall medical devices under this section does not apply to a medical device that cannot be recalled because it has been administered to, or applied in the treatment of, a person.