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Medical devices and IVDs: Cancellations from the ARTG

12 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 1 - 25 of 498

2021

Date of effect: 5 May 2021

Bug Bandits

Product name/ARTG reference: Mask, <specify>

ARTG number: 341692

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

Non response following s41JA

Date of effect: 22 Apr 2021

Australia Health Way Pty Ltd

Product name/ARTG reference: Public face mask, reusable

ARTG number: 342987

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

Non response to a s41JA

Date of effect: 22 Apr 2021

Australia Top 1 Health Management Pty Ltd

Product name/ARTG reference: Airway protection face mask

ARTG number: 338932

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

Non response to a s41JA

Date of effect: 22 Apr 2021

Maroon Tree Pty Ltd

Product name/ARTG reference: Mask, surgical, reusable

ARTG number: 343733

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

Non response to a s41JA

Date of effect: 21 Apr 2021

R&H Imports

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

ARTG number: 343443

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

Non response to a s41JA

Date of effect: 21 Apr 2021

Health Equipment Supplies

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

ARTG number: 345433

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

Non response to a s41JA

Date of effect: 21 Apr 2021

MK Visy Pty Ltd

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

ARTG number: 341502

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

Non response to a s41JA

Date of effect: 21 Apr 2021

INQ Innovation Global Pty Ltd

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

ARTG number: 342095

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

Non response to a s41JA

Date of effect: 21 Apr 2021

INQ Innovation Global Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 342555

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

Non response to a s41JA

Date of effect: 21 Apr 2021

Intex International Group Pty Ltd

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

ARTG number: 339478

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

Non response to a s41JA

Date of effect: 31 Mar 2021

Arslan Mukhtar

Product name/ARTG reference: Mask, <specify>

ARTG number: 338753

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

Non response to a s41JA

Date of effect: 31 Mar 2021

Sixty Third Raven Pty Ltd

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

ARTG number: 340389

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

Non response to a s41JA

Date of effect: 31 Mar 2021

Protective Personal Product Solutions Pty Ltd

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

ARTG number: 342632

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

Non response to a s41JA

Date of effect: 30 Mar 2021

Big Start Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 336365

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

Non response to a s41JA

Date of effect: 30 Mar 2021

Big Start Pty Ltd

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

ARTG number: 340632

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

Non response to a s41JA

Date of effect: 30 Mar 2021

Big Start Pty Ltd

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

ARTG number: 340635

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

Non response to a s41JA

Date of effect: 30 Mar 2021

Big Start Pty Ltd

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

ARTG number: 340642

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

Non response to a s41JA

Date of effect: 30 Mar 2021

Big Start Pty Ltd

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

ARTG number: 341116

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

Non response to a s41JA

Date of effect: 22 Mar 2021

Australia Top 1 Health Management Pty Ltd

Product name/ARTG reference: Airway protection face mask

ARTG number: 338932

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

Non response to a s41JA

Date of effect: 22 Mar 2021

Maroon Tree Pty Ltd

Product name/ARTG reference: Mask, surgical, reusable

ARTG number: 343733

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

Non response to a s41JA

Date of effect: 22 Mar 2021

Australia Health Way Pty Ltd

Product name/ARTG reference: Public face mask, reusable

ARTG number: 342987

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

Non response to a s41JA

Date of effect: 21 Mar 2021

R&H Imports

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

ARTG number: 343443

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

Non response to a s41JA

Date of effect: 21 Mar 2021

Health Equipment Supplies

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

ARTG number: 345433

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

Non response to a s41JA

Date of effect: 21 Mar 2021

MK Visy Pty Ltd

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

ARTG number: 341502

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

Non response to a s41JA

Date of effect: 21 Mar 2021

INQ Innovation Global Pty Ltd

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

ARTG number: 342095

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

Non response to a s41JA

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