Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020
I, Glenys Beauchamp, as delegate of the Minister for Health, make the following exemption.
Dated 31 January 2020
Glenys Beauchamp
Secretary
Department of Health
Contents
1 Name
2 Commencement
3 Authority
4 Definitions
5 Exemption
6 Conditions
1 Name
This instrument is the Therapeutic Goods (Medical Devices—Novel Coronavirus) (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. | 31 January 2020 |
Note: This table relates only to the provisions of this instrument as originally made.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:
Act means the Therapeutic Goods Act 1989.
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
novel coronavirus means the disease known as novel coronavirus (2019-nCoV) infection, first identified in Wuhan, Hubei Province, China in 2019.
relevant kinds of medical devices means kinds of medical devices that are used for the diagnosis, confirmatory testing, prevention, monitoring, treatment or alleviation of novel coronavirus.
5 Exemption
(1) Relevant kinds of medical devices are exempt from:
(a) Division 1 of Part 4-2 of the Act (essential principals); 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);
when imported, exported, manufactured or supplied to deal with the threat to public health caused by the novel coronavirus emergency.
Note: Under subsection 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) relevant kinds of medical devices must only be imported, exported, manufactured or supplied by a laboratory that is a state or territory member of the Public Health Laboratory Network; and
(b) a laboratory mentioned in paragraph (a) must keep records in relation to the importation, exportation, manufacture and supply of the relevant kinds of medical devices; and
(c) on request from the Secretary, the laboratory must make the records mentioned in paragraph (b) available to the Secretary.
Note: Regulation 6A.1 and Schedule 3A of the Medical Devices Regulations set out arrangements for the disposal of unused emergency medical devices for the purposes of section 41GY of the Act.
Overview
The Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020 was enacted on 31 January 2020, addressing the urgent need for rapid availability of medical devices to manage the threat posed by the novel coronavirus emergency. This exemption was issued by Glenys Beauchamp, as delegate of the Minister for Health, under section 41GS of the Therapeutic Goods Act 1989, in response to an actual threat to public health. The exemption aims to facilitate the timely importation, exportation, manufacturing, and supply of medical devices specifically intended for the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of the novel coronavirus. The exemption is in effect from its commencement until 31 January 2021 and is subject to conditions, including that only designated laboratories, which are members of the Public Health Laboratory Network, can handle these devices and maintain detailed records of their activities, which must be made available to the Secretary upon request.
Scope and Application
The Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020 applies to specific types of medical devices used for diagnosing, testing, preventing, monitoring, treating, or alleviating the effects of the novel coronavirus. This exemption is geographically applicable throughout Australia and is made under section 41GS of the Therapeutic Goods Act 1989. The exemption exempts relevant medical devices from certain regulatory requirements when they are imported, exported, manufactured, or supplied to address the public health threat posed by the novel coronavirus. The exemption is limited to devices used in the context of this emergency and is effective from its commencement on 31 January 2020 until 31 January 2021. The exemption is conditional upon the devices being handled only by laboratories that are members of the Public Health Laboratory Network of states or territories, with these laboratories required to maintain detailed records and make them available upon request from the Secretary. This exemption allows for the urgent availability of necessary medical devices while ensuring compliance with public health standards.
Key Provisions
The Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020 (sections 1-6) provides exemptions for certain medical devices used in the context of the novel coronavirus (COVID-19) emergency. This exemption exempts relevant kinds of medical devices from several parts of the Therapeutic Goods Act 1989 (sections 5 and 6), including essential principles, conformity assessment procedures, conformity assessment certificates, and inclusion in the Register, when these devices are imported, exported, manufactured, or supplied in response to the public health threat posed by the novel coronavirus. The exemption, effective from 31 January 2020, will remain in force until 31 January 2021.
Entities and individuals governed by this Act must adhere to specific obligations and conditions outlined in the legislation. For instance, only laboratories that are members of the Public Health Laboratory Network of the relevant state or territory are authorised to import, export, manufacture, or supply the exempted medical devices (section 6(a)). Additionally, these laboratories must maintain detailed records of their activities involving the relevant medical devices and make these records available to the Secretary upon request (section 6(b) and (c)). These conditions are designed to ensure that the devices are handled responsibly and that there is accountability for their use in addressing the public health emergency.
Failure to comply with the conditions set out in the exemption or misuse of the exempted medical devices may result in various legal consequences. Although the specific penalties for breaches are not detailed in the text, it is known that contraventions of the Therapeutic Goods Act 1989 can result in substantial penalties. For example, for a corporation, the penalties can include fines up to $2.1 million or three times the benefit obtained from the contravention, and for individuals, the fines can reach up to $210,000 or three times the benefit obtained from the contravention, in addition to potential imprisonment terms. These severe penalties underscore the importance of strict compliance with the Act's provisions and conditions.