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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 26 - 50 of 507

2021

Date of effect: 19 Mar 2021

South Yarra News & Lotto

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

ARTG number: 340302

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

WILLIESTON INTERNATIONAL PTY LTD

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

ARTG number: 340771

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

WILLIESTON INTERNATIONAL PTY LTD

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

ARTG number: 340753

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

GBT Express Pty Ltd

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

ARTG number: 341174

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

Yex International Pty Ltd

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

ARTG number: 342052

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

Vandar Pty Ltd

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

ARTG number: 342899

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

J Lian Pty Ltd

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

ARTG number: 338138

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

Hargovind Pty Ltd

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

ARTG number: 339181

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

JRL SOLAR PTY LTD

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

ARTG number: 333735

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

JRL SOLAR PTY LTD

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

ARTG number: 333736

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

Mincorli Pty Ltd

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

ARTG number: 338930

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

MLM Corp Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 339642

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

MLM Corp Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 339809

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 19 Mar 2021

MLM Corp Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 339811

Type of regulatory action: Cancellation after 20 days 41GM(1) Non response following s41JA

Non response to a s41JA

Date of effect: 5 Mar 2021

Vinrec Australia Pty Ltd

Product name/ARTG reference: Airway protection face mask

ARTG number: 341175

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

Non response to a s41JA

Date of effect: 5 Mar 2021

Vinrec Australia Pty Ltd

Product name/ARTG reference: Airway protection face mask

ARTG number: 341501

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

Non response to a s41JA

Date of effect: 5 Mar 2021

Vinrec Australia Pty Ltd

Product name/ARTG reference: Airway protection face mask

ARTG number: 341814

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

Non response to a s41JA

Date of effect: 5 Mar 2021

TOWARDS GROUP HOLDING PTY LTD

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

ARTG number: 339997

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

Failure to comply with s41JA within a further 10 days

Date of effect: 5 Mar 2021

TOWARDS GROUP HOLDING PTY LTD

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

ARTG number: 341718

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

Failure to comply with s41JA within a further 10 days

Date of effect: 5 Mar 2021

KCM Hygiene Pty Ltd

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

ARTG number: 325345

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

Failure to comply with s41JA within a further 10 days

Date of effect: 4 Mar 2021

BlueMountain Healthcare Pty Ltd

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

ARTG number: 335361

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1)(c), (f) and 41FD(d) of the Act.

Failure to comply with s41JA within a further 10 days, poor device safety and incorrect certification

Date of effect: 4 Mar 2021

Face mask Edit

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

ARTG number: 341399

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

Non response to a s41JA

Date of effect: 1 Mar 2021

ENVIRO TECH HOLDING PTY LTD

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

ARTG number: 341652

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

Non response to a s41JA

Date of effect: 1 Mar 2021

ENVIRO TECH HOLDING PTY LTD

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

ARTG number: 345617

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

Non response to a s41JA

Date of effect: 22 Feb 2021

Eco Corporation

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

ARTG number: 341643

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

Non response to a s41JA

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