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Medical devices and IVDs: Cancellations from the ARTG

20 May 2021

Following a review by the TGA, medical device entries (including IVDs) can be cancelled from the Australian Register of Therapeutic Goods. These cancellations are made by the Secretary under section 41GK, 41GL, 41GM and 41GN of the Therapeutic Goods Act 1989.

Where other actions are taken in relation to safety, the TGA will generally publish additional information about the issue on its alerts page.

The reasons for a cancellation are stated in the database below under 'Grounds for cancellation'.

The heading 'Decision status' provides updated information about cancellation decisions, for example information about any decision to revoke a cancellation decision. It will not appear in every entry.

To find out whether a product is currently authorised for supply in Australia, check the ARTG.

For cancellations that result in only one or more medical devices of a kind being cancelled and not the entry removed from the ARTG, see:

For cancellations of face masks following post-market review, see: Post-market review of face masks: Cancelled ARTG entries

Medical devices and IVD cancellations

Displaying 101 - 125 of 507

2021

Date of effect: 14 Jan 2021

TRANSCEND INDUSTRIES PTY LTD

Product name/ARTG reference: Surgical/medical respirator, single-use

ARTG number: 335026

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 14 Jan 2021

Directlink Global

Product name/ARTG reference: Public respirator, single-use

ARTG number: 334346

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 14 Jan 2021

Directlink Global

Product name/ARTG reference: Public respirator, single-use

ARTG number: 335565

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 12 Jan 2021

Tinawells Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 332563

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 12 Jan 2021

Tinawells Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 336117

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 12 Jan 2021

Tinawells Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340298

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 12 Jan 2021

Tinawells Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340491

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 11 Jan 2021

Jac International Trading Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 332682

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 7 Jan 2021

Innovation Drive Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 335549

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following a s41JA

Date of effect: 6 Jan 2021

Da Shi

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 334604

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

2020

Date of effect: 24 Dec 2020

UTN GROUP PTY LTD

Product name/ARTG reference: Public respirator, single-use

ARTG number: 335629

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 24 Dec 2020

UTN GROUP PTY LTD

Product name/ARTG reference: Public respirator, single-use

ARTG number: 335631

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 18 Dec 2020

Inivos Pty Ltd

Product name/ARTG reference: Ultraviolet room disinfection system [62893]

ARTG number: 342507

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1) of the Act.

The product is an excluded good for the purposes of the Act, that is, the product is determined not to be a therapeutic good. Therefore the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion, that the product is a medical device, is incorrect.

Date of effect: 17 Dec 2020

Jardini Pty Ltd

Product name/ARTG reference: Surgical/medical respirator, single-use

ARTG number: 335996

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following s41JA

Date of effect: 17 Dec 2020

Jardini Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 335619

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following s41JA

Date of effect: 17 Dec 2020

Jardini Pty Ltd

Product name/ARTG reference: Public respirator, single-use

ARTG number: 334624

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following s41JA

Date of effect: 17 Dec 2020

Jardini Pty Ltd

Product name/ARTG reference: Public respirator, single-use

ARTG number: 334625

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following s41JA

Date of effect: 9 Dec 2020

Germii UV-C Sterilization Pty Ltd

Product name/ARTG reference: Ultraviolet room disinfection system [62893]

ARTG number: 345368

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1) of the Act.

The product is not a medical device. Therefore, the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion is incorrect

Date of effect: 9 Dec 2020

T R Lord & Associates

Product name/ARTG reference: Camera, thermographic [36731]

ARTG number: 345344

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1) of the Act.

The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.

Date of effect: 9 Dec 2020

T R Lord & Associates

Product name/ARTG reference: Camera, thermographic [36731]

ARTG number: 345343

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1) of the Act.

The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.

Date of effect: 8 Dec 2020

T R Lord & Associates

Product name/ARTG reference: Camera, thermographic [36731]

ARTG number: 344532

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1) of the Act

The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.

Date of effect: 7 Dec 2020

GT Construction Australia

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 334303

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1) of the Act.

Failure to comply with a condition of inclusion

Date of effect: 3 Dec 2020

Prestige Worldwide Imports Pty Ltd

Product name/ARTG reference: Public respirator, single-use

ARTG number: 335569

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following a s41JA

Date of effect: 3 Dec 2020

Prestige Worldwide Imports Pty Ltd

Product name/ARTG reference: Public respirator, single-use

ARTG number: 335564

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following a s41JA

Date of effect: 3 Dec 2020

Prestige Worldwide Imports Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 336113

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response following a s41JA

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