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SLI 2010 No. 267 Regulations as made
These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 to allow reduced assessment fees relating to IVDs where, under specified circumstances, an abridged assessment can be carried out.
Administered by: Health
Registered 29 Oct 2010
Tabling HistoryDate
Tabled HR15-Nov-2010
Tabled Senate15-Nov-2010
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 3)1

Select Legislative Instrument 2010 No. 267

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 27 October 2010

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

CATHERINE KING


1              Name of Regulations

                These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 3).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

                Schedule 1 amends the Therapeutic Goods (Medical Devices) Regulations 2002.


Schedule 1        Amendments

(regulation 3)

 

[1]           After Part 6

insert

Part 6A               Disposal of unused emergency medical devices

  

6A.1        Disposal of unused emergency medical devices

         (1)   For subsection 41GY (2) of the Act, the arrangements for disposal of unused emergency medical devices are set out in Schedule 3A.

         (2)   Nothing in this regulation or in Schedule 3A is taken to prevent a disposal of unused emergency medical devices if:

                (a)    the devices have 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; and

               (b)    the disposal is in accordance with other provisions of the Act and these Regulations relevant to the devices.

[2]           Paragraphs 9.7 (1) (a) and (b)

substitute

                (a)    items 1.2, 1.3 and 1.3A (review of conformity assessment certificate);

               (b)    items 1.9 and 1.9A (initial assessment under conformity assessment procedures);

[3]           After paragraph 9.7 (1) (c)

insert

              (ca)    item 1.10A (assessment because of changes or proposed changes to:

                          (i)    an IVD medical device; or

                         (ii)    the quality management system applying to an IVD medical device);

[4]           Paragraph 9.7 (1) (d)

substitute

               (d)    items 1.13, 1.14 and 1.14A (application subject to audit assessment);

[5]           After Schedule 3

insert

Schedule 3A      Disposal of unused emergency medical devices

(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;

               (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 section 41HC of the Act — the person to whom the authority is given.

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 destroy the devices.

[6]           Schedule 4, Part 2, after item 2.10

insert

2.11

Unused emergency medical devices directed by the Secretary, under clause 7 of Schedule 3A, to be exported

compliance with Schedule 3A, as if section 41GY of the Act applies to the devices

[7]           Dictionary, after definition of type examination procedures

insert

unused emergency medical devices means medical devices to which section 41GY of the Act applies.


Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.