Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(regulation 6A.1)
1 Early end of exemption--notice of medical devices held
(1) This clause applies if:
(a) the Minister makes an exemption under section 41GS of the Act in relation to kinds of medical devices; and
(b) a person is given a copy of a revocation or variation of the exemption under paragraph 41GV(b) of the Act.
(2) The person must give the Secretary:
(a) notice, in writing, of the quantity and location of:
(i) for a revocation--the devices over which the person has control that have not been used; or
(ii) for a variation--the devices mentioned in the variation over which the person has control that have not been used; and
(b) a copy of any records about the devices that the person is required to keep under a condition of the exemption.
(3) The person must comply with subclause (2) in relation to the devices within 7 days after the day the exemption ends for the devices.
2 End of exemption period--notice of medical devices held
(1) This clause applies if an exemption under section 41GS of the Act ends because the period stated in the exemption ends.
(2) A person who has been importing, manufacturing, supplying or exporting medical devices under the exemption must, within 7 days after the day the period ends, give the Secretary:
(a) notice, in writing, of the quantity and location of any unused emergency medical devices over which the person has control; and
(b) a copy of any records about the devices that the person is required to keep under a condition of the exemption.
3 Storage and disposal of unused emergency medical devices
(1) A person who has control over unused emergency medical devices must ensure that the devices are stored in a way that ensures that:
(a) the devices are only accessible for supply, export, use or disposal in accordance with the Act and these Regulations; and
(b) the security of the devices is appropriate to the level of risk that the devices could pose to the public and the environment; and
(c) the integrity of the condition of the devices is maintained.
(2) A person may dispose of unused emergency medical devices only in accordance with a direction given by the Secretary under subclause 4(1).
4 Direction for disposal of unused emergency medical devices
(1) The Secretary may direct, in writing, any person who has control over unused emergency medical devices to dispose of the devices in the way directed.
(2) A direction under subclause (1) must be in accordance with clause 5, 6, 7 or 8.
(3) A person who has been given a direction under subclause (1) must comply with the direction.
5 Relocation of unused emergency medical devices
If storage of unused emergency medical devices at a place poses, or would pose, a risk to the public or the environment, the Secretary may direct that the devices be stored at a stated place that will ensure compliance with subclause 3(1).
6 Disposal of unused emergency medical devices--destruction
(1) The Secretary may direct that unused emergency medical devices be destroyed within the time stated in the direction if any of the following applies:
(a) the devices have passed their expiry date;
(b) the devices no longer comply with the essential principles;
(c) conformity assessment procedures were not applied to the devices and requirements, comparable to the conformity assessment procedures, were not applied to the devices;
(d) use of the devices poses, or would pose, a risk to public health;
(e) storage of the devices at their current location and any other location poses, or would pose, a risk to the public or the environment;
(f) within 12 months after the exemption ends in relation to the devices, the devices have not become:
(i) devices of a kind included in the Register under Part 4 - 5 of the Act; or
(ii) exempt devices under section 41HA of the Act; or
(iii) devices that are the subject of an approval under section 41HB of the Act; or
(iv) devices that are the subject of an authority under section 41HC of the Act;
(g) the person who has control over the devices requests that the devices be destroyed.
(2) A person directed to destroy the devices may destroy them only in a way, approved by the Secretary, that ensures that the destruction avoids or minimises harm to the public and the environment.
7 Disposal of unused emergency medical devices--export
(1) This clause applies to unused emergency medical devices to which any of paragraphs 6(1)(a) to (e) applies.
(2) The Secretary may direct that the devices be exported to a country, instead of directing that they be destroyed, if a relevant authority of the country has confirmed in writing its willingness to accept the devices.
(3) A person directed to export the devices must ensure that, during exportation:
(a) the devices are only accessible for purposes relating to the export; and
(b) the security of the devices is appropriate to the level of risk that the devices could pose to the public and the environment; and
(c) the integrity of the condition of the devices is maintained.
8 Disposal of unused emergency medical devices--supply
(1) This clause applies to:
(a) unused emergency medical devices that are a kind of medical device if:
(i) an exemption under section 41GS of the Act in relation to that kind of medical device ceases to have effect other than because that kind of medical device becomes included in the Register under Part 4 - 5 of the Act; and
(ii) the devices later become devices of a kind included in the Register under Part 4 - 5 of the Act; and
(b) unused emergency medical devices that have become:
(i) devices that are the subject of an approval under section 41HB of the Act; or
(ii) devices that are the subject of an authority under section 41HC of the Act.
(2) The Secretary may direct that the devices be supplied to an authorised person (otherwise than for therapeutic use on the person).
(3) In this clause:
"authorised person" means:
(a) for paragraph (1)(a)--the person in relation to whom the kind of medical device is included in the Register under Part 4 - 5 of the Act; or
(b) for an approval under section 41HB of the Act--the person to whom the approval is given; or
(c) for an authority under subsection 41HC(1) of the Act--the person to whom the authority is given; or
(d) for an authority given by rules made under subsection 41HC(6) of the Act--a health practitioner included in the class of health practitioners specified in the rules.
9 Owner to be paid for medical devices supplied
A direction under clause 7 or 8 does not affect a person's liability to pay the owner of the unused emergency medical devices for the export or supply of the devices to the person.
10 Records about unused emergency medical devices
A person who has, or has had, control over unused emergency medical devices must:
(a) ensure that records are kept that include the following information:
(i) the quantities of the devices under the person's control;
(ii) how the devices are stored before being disposed of;
(iii) if a direction under subclause 4(1) has been received--what actions have been taken to dispose of the devices as directed and when the actions were taken;
(iv) if the devices have been exported or supplied--to whom they were exported or supplied and in what quantity; and
(b) keep the records for 7 years after the last entry is made; and
(c) if the Secretary asks the person, in writing, for a copy of a record mentioned in paragraph (a)--give the Secretary the copy:
(i) within 14 days after the day the person is given the Secretary's request; or
(ii) if the information is required to establish whether the devices pose imminent risk to the public or the environment--within 24 hours, or any shorter period, stated by the Secretary.
11 Failure to comply with this Schedule
If a person who has control over any unused emergency medical devices has not complied with a provision of this Schedule, the Secretary may direct a person, other than the person who has control over the devices, to destroy the devices in the way directed.