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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 1 - 25 of 515

2021

Date of effect: 21 Jun 2021

Envon Pty Ltd

Product name/ARTG reference: Severe acute respiratory syndrome-associated coronavirus IVDs

ARTG number: 333160

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

Non response to a s41JA

Date of effect: 16 Jun 2021

Laleen Health International Pty LTD

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

ARTG number: 340005

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

Non response to a s41JA

Date of effect: 16 Jun 2021

Rudhran Holdings Pty Ltd

Product name/ARTG reference: Airway protection face mask

ARTG number: 334345

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

Non response to a s41JA

Date of effect: 16 Jun 2021

Heng Rui Australian Investment

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

ARTG number: 333718

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

Non response to a s41JA

Date of effect: 16 Jun 2021

Hystar Pty Ltd

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

ARTG number: 335347

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

Non response to a s41JA

Date of effect: 16 Jun 2021

Covid Solutions Pty Ltd

Product name/ARTG reference: Severe acute respiratory syndrome-associated coronavirus IVDs

ARTG number: 342730

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

Non response to a s41JA

Date of effect: 16 Jun 2021

H3 Diagnostics Pty Ltd

Product name/ARTG reference: Severe acute respiratory syndrome-associated coronavirus IVDs

ARTG number: 340611

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

Non response to a s41JA

Date of effect: 7 Jun 2021

Pacific Dental Specialties Pty Ltd

Product name/ARTG reference: Suture, polytetrafluoroethylene

ARTG number: 303441

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

The sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a).

Date of effect: 17 May 2021

Total E&P Australia

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

ARTG number: 342093

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

Non response to a s41JA

Date of effect: 17 May 2021

The Trustee for ABY Imports Trust

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

ARTG number: 341691

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

Non response to a s41JA

Date of effect: 12 May 2021

Mombasa Trading Pty Ltd

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

ARTG number: 333971

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

Non response to a s41JA

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

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: 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: 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

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