Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020

Administered by Department of Health, Disability and Ageing

Legislation au F2020N00032 Not in force Notifiable Instrument

Legislation content

 

Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020

I, Caroline Edwards, as delegate of the Minister for Health, make the following exemption.

Dated 22 March 2020

Caroline Edwards

Acting Secretary

Department of Health

 

Contents

1  Name

2  Commencement

3  Authority

4  Definitions

5  Exemption

6  Conditions

7  Repeals

Schedule 1—Repeals

Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020

 

1  Name

  This instrument is the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day this instrument is made.

 

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under section 41GS of the Therapeutic Goods Act 1989.

4  Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

(a) conformity assessment certificate;

(b) conformity assessment procedures;

(c) essential principles;

(d) medical device;

(e) Register; and

(f) Secretary.

  In this instrument:

accredited pathology laboratory has the same meaning as in the Health Insurance Act 1973.

Act means the Therapeutic Goods Act 1989.

COVID-19 emergency means the public health emergency caused by the outbreak of the disease known as coronavirus disease (COVID-19).

Note: The World Health Organization declared the outbreak of COVID-19, formerly novel coronavirus (2019 nCoV), a Public Health Emergency of International Concern on 30 January 2020, and subsequently characterised the outbreak as a pandemic on 11 March 2020.

IVD medical device has the same meaning as in the Regulations.

Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

relevant kinds of medical devices means medical devices that are IVD medical devices used for the diagnosis, confirmatory testing, prevention, monitoring, treatment or alleviation of coronavirus disease (COVID-19).

5  Exemption

 (1) Relevant kinds of medical devices are exempt from:

 (a) Division 1 of Part 4-2 of the Act (essential principles); and

 (b) Division 1 of Part 4-3 of the Act (conformity assessment procedures); and

 (c) Part 4-4 of the Act (conformity assessment certificates); and

 (d) Part 4-5 of the Act (including medical devices in the Register);

in order to deal with the threat to public health caused by the COVID-19 emergency.

Note: Under paragraph 41GS(2)(b) of the Act, the Minister may make an exemption under subsection 41GS(1) only if satisfied that, in the national interest, the exemption should be made so that the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.

Period of exemption

 (2) This exemption comes into force on the commencement of this instrument and remains in force until 31 January 2021.

6  Conditions

  This exemption is subject to the following conditions:

 (a) the relevant kinds of medical devices must only be:

 (i) imported, manufactured or supplied by, or on behalf of, an accredited pathology laboratory; or

 (ii) imported or manufactured by another person for supply to an accredited pathology laboratory; and

 (b) the laboratory mentioned in subparagraph (a)(i) or the person mentioned in subparagraph (a)(ii) must keep records in relation to such importation, manufacture and supply of the relevant kinds of medical devices for which that laboratory or person is responsible; and

 (c) on request from the Secretary, the laboratory mentioned in subparagraph (a)(i) or the person mentioned in subparagraph (a)(ii) must make the records mentioned in paragraph (b) available to the Secretary.

Note 1: There are offences and civil penalty provisions related to the breach of a condition: see Division 3A of Part 4-11 of the Act.

Note 2: Regulation 6A.1 and Schedule 3A of the Regulations set out arrangements for the disposal of unused emergency medical devices for the purposes of section 41GY of the Act.

7  Repeals

  Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in the applicable items in that Schedule.


Schedule 1—Repeals

Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020

1  The whole of the instrument

Repeal the instrument

 

 

Overview

The Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, issued under the authority of the Therapeutic Goods Act 1989, was enacted to swiftly address the public health threat posed by the COVID-19 pandemic. The exemption, made by Caroline Edwards, acting on behalf of the Minister for Health, aims to facilitate the urgent availability of relevant medical devices in Australia by exempting accredited pathology laboratories from specific regulatory requirements. This legislative measure was necessary to enable a rapid response to the emergency, ensuring that essential diagnostic and treatment tools could be swiftly deployed to combat the spread of the virus. The exemption is in effect from the date of its enactment and will remain in force until 31 January 2021, subject to conditions that ensure the controlled and monitored distribution of these medical devices.

Scope and Application

The Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 applies to accredited pathology laboratories as defined under the Health Insurance Act 1973 and to relevant kinds of medical devices used for the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of coronavirus disease (COVID-19). The exemption is made under section 41GS of the Therapeutic Goods Act 1989 and operates on a national level, aiming to expedite the availability of medical devices to address the public health threat posed by the COVID-19 emergency. This exemption excludes certain requirements of the Therapeutic Goods Act 1989, including essential principles, conformity assessment procedures, conformity assessment certificates, and the inclusion of medical devices in the Register. The exemption is in effect from the date of its creation and remains in force until 31 January 2021, subject to conditions that the relevant medical devices must be handled by accredited pathology laboratories or entities supplying to such laboratories, with obligations to maintain and provide access to records of importation, manufacture, and supply upon request by the Secretary. The exemption also repeals the Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020, consolidating regulatory measures under this single instrument.

Key Provisions

The Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 (section 1) is designed to facilitate the urgent availability of certain medical devices during the COVID-19 pandemic. This exemption, made under section 41GS of the Therapeutic Goods Act 1989, provides relief from specific regulatory requirements to address the public health threat posed by COVID-19. Specifically, the exemption exempts relevant kinds of medical devices—those used for the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19—from certain sections of the Act, including essential principles, conformity assessment procedures, conformity assessment certificates, and the inclusion of medical devices in the Register (section 5(1)). The exemption imposes certain obligations on the parties it governs. Accredited pathology laboratories and other entities involved in the importation, manufacture, or supply of these devices must ensure that these activities are conducted under the purview of an accredited pathology laboratory or on behalf of such a laboratory (section 6(a)). Furthermore, they are required to maintain detailed records pertaining to these activities and make these records accessible to the Secretary upon request (section 6(b) and (c)). Breaches of the conditions specified in this exemption can result in significant consequences. The Act includes offences and civil penalty provisions related to the non-compliance of these conditions, as outlined in Division 3A of Part 4-11 of the Therapeutic Goods Act 1989. While the specific penalties are not detailed in the exemption itself, the Act generally allows for substantial fines and potential criminal charges for serious or repeated breaches, depending on the nature and severity of the violation. Additionally, Regulation 6A.1 and Schedule 3A of the Therapeutic Goods (Medical Devices) Regulations 2002 detail the arrangements for the disposal of unused emergency medical devices under section 41GY of the Act, providing further regulatory oversight and accountability mechanisms.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.