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Medical devices and IVDs: Cancellations from the ARTG

16 September 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 582

2021

Date of effect: 10 Sep 2021

Mediflex Industries Pty Ltd

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

ARTG number: 299954

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

Nonresponse to a s41JA

Date of effect: 9 Sep 2021

STANDARD MEDICAL SUPPLIES PTY LTD

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

ARTG number: 337428

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

Nonresponse to a s41JA

Date of effect: 9 Sep 2021

Above Clothing Pty Ltd

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

ARTG number: 344156

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

Nonresponse to a s41JA

Date of effect: 9 Sep 2021

Michael Darby

Product name/ARTG reference: Mask, surgical, reusable

ARTG number: 335621

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

Nonresponse to a s41JA

Date of effect: 9 Sep 2021

OEI Trading

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

ARTG number: 336582

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

Failure to comply with a condition of inclusion

Date of effect: 9 Sep 2021

OEI Trading

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

ARTG number: 334142

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

Nonresponse to a s41JA

Date of effect: 9 Sep 2021

OEI Trading

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

ARTG number: 333969

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

Nonresponse to a s41JA

Date of effect: 8 Sep 2021

Shifa Dental Supplies

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

ARTG number: 340250

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

Nonresponse to a s41JA

Date of effect: 2 Sep 2021

Globaleyes Distribution Pty Ltd

Product name/ARTG reference: Public Respirator, Single use

ARTG number: 337214

Type of regulatory action: Cancellation from the ARTG under section 9F(2) of the Act

Removal of Excluded Goods

Date of effect: 2 Sep 2021

Globaleyes Distribution Pty Ltd

Product name/ARTG reference: Public Respirator, Single use

ARTG number: 337446

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

Nonresponse to a s41JA

Date of effect: 26 Aug 2021

Orso International Pty Ltd

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

ARTG number: 335336

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

Nonresponse to a s41JA

Date of effect: 26 Aug 2021

Simcare Pty Ltd

Product name/ARTG reference: Mask, surgical, reusable

ARTG number: 334841

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

Nonresponse to a s41JA

Date of effect: 26 Aug 2021

J & K Trading Pty Ltd

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

ARTG number: 334315

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

Nonresponse to a s41JA

Date of effect: 26 Aug 2021

Hui Cheng International Pty Ltd

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

ARTG number: 334323

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

Nonresponse to a s41JA

Date of effect: 26 Aug 2021

KSJ Pharmatech

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

ARTG number: 331987

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

Nonresponse to a s41JA

Date of effect: 26 Aug 2021

Next Generational Occupational Medicine Devices

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

ARTG number: 336513

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

Failure to comply with a condition of inclusion

Date of effect: 26 Aug 2021

Prolotus Australia Pty Ltd ATF Davis Family Trust T/A ATX Medical Solutions

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

ARTG number: 333250

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

Nonresponse to a s41JA

Date of effect: 25 Aug 2021

Key2Asia

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

ARTG number: 340855

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

Nonresponse to a s41JA

Date of effect: 25 Aug 2021

Harcor Security Seals Pty Ltd

Product name/ARTG reference: Public respirator, single use

ARTG number: 340516

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

Nonresponse to a s41JA

Date of effect: 23 Aug 2021

Lightyear Science and Technology Pty Ltd

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

ARTG number: 334932

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

Nonresponse to a s41JA

Date of effect: 23 Aug 2021

Pacific Garment Pty Ltd

Product name/ARTG reference: Public respirator, single use

ARTG number: 334348

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

Nonresponse to a s41JA

Date of effect: 23 Aug 2021

Pacific Garment Pty Ltd

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

ARTG number: 334349

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

Nonresponse to a s41JA

Date of effect: 23 Aug 2021

Pacific Garment Pty Ltd

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

ARTG number: 335210

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

Nonresponse to a s41JA

Date of effect: 19 Aug 2021

Maya Corporation Pty Ltd

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

ARTG number: 340237

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

Nonresponse to a s41JA

Date of effect: 9 Aug 2021

Aspen Medical Pty Ltd

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

ARTG number: 336492

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

Failure to comply with a condition of inclusion

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