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Medical devices and IVDs: Cancellations from the ARTG

22 June 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 176 - 200 of 515

2020

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334020

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334022

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334023

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334024

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334025

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Pluspak Safety Pty Ltd

Product name/ARTG reference: Surgical/medical face mask, reprocessed [64847]

ARTG number: 338402

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

The sponsor failed to provide information requested by the Secretary therefore the sponsor failed to comply with an automatic condition of inclusion under paragraph 41FN(3)(c) of the Act.

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334026

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Fasteners and More Pty Ltd

Product name/ARTG reference: Thermometer, infrared, skin [17888]

ARTG number: 335585

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

The sponsor failed to provide information requested by the Secretary therefore the sponsor failed to comply with an automatic condition of inclusion under paragraph 41FN(3)(c) of the Act.

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334027

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334339

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 333710

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Concierge Contacts Pty Ltd

Product name/ARTG reference: Antiseptic swab [13913]

ARTG number: 336282

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: 7 Oct 2020

Seizure Alert Australia

Product name/ARTG reference: Home seizure monitoring system [61288]

ARTG number: 330647

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

The sponsor failed to provide information requested by the Secretary therefore the sponsor failed to comply with an automatic condition of inclusion under paragraph 41FN(3)(c) of the Act.

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 333711

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 333712

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 333949

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Big Start Pty Ltd

Product name/ARTG reference: Thermometer, infrared, skin

ARTG number: 340810

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

The device is incorrectly classified therefore the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.

Date of effect: 1 Oct 2020

ASC Trading Pty Ltd

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

ARTG number: 334041

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

Non response to a s41JA

Date of effect: 1 Oct 2020

ASC Trading Pty Ltd

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

ARTG number: 334256

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

Non response to a s41JA

Date of effect: 1 Oct 2020

Aurelia Union Pty Ltd

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

ARTG number: 334872

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

Non response to a s41JA

Date of effect: 1 Oct 2020

Australia Fudao Pty Ltd

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

ARTG number: 336196

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

Non response to a s41JA

Date of effect: 1 Oct 2020

Australia Fudao Pty Ltd

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

ARTG number: 336197

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

Non response to a s41JA

Date of effect: 1 Oct 2020

Australia Resources Pty Ltd

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

ARTG number: 334042

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

Non response to a s41JA

Date of effect: 1 Oct 2020

Australian Pacific Medical Pty Ltd

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

ARTG number: 336063

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

Non response to a s41JA

Date of effect: 1 Oct 2020

AP Surgical Pty Ltd

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

ARTG number: 335151

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

Non response to a s41JA

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