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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 126 - 150 of 507

2020

Date of effect: 3 Dec 2020

Prestige Worldwide Imports Pty Ltd

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

ARTG number: 335703

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

Non response following a s41JA

Date of effect: 3 Dec 2020

Prestige Worldwide Imports Pty Ltd

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

ARTG number: 335617

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

Non response following a s41JA

Date of effect: 3 Dec 2020

Prestige Worldwide Imports Pty Ltd

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

ARTG number: 335616

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

Non response following a s41JA

Date of effect: 2 Dec 2020

Haemokinesis Pty Ltd

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

ARTG number: 335597

Type of regulatory action: Cancellation from the ARTG under s41GN(1)

The sponsor failed to demonstrate that the Device complies with Essential Principles 1,3,6,13, 14 and 15.

Date of effect: 26 Nov 2020

TELECORE AUSTRALIA PTY LTD

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

ARTG number: 331772

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

The Sponsor failed to comply with the notice under section 41JA within a further 10 working days.

Date of effect: 25 Nov 2020

Enviro Tech Holdings Pty Ltd

Product name/ARTG reference: Disinfectant, <specify> [31079]

ARTG number: 344321

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

The product is not a medical device therefore the certifications made under section 41FD of the Act at the time of application are incorrect.

Date of effect: 23 Nov 2020

Owen Kelly & Associates

Product name/ARTG reference: Surgical/examination garment kit [61938]

ARTG number: 338632

Type of regulatory action: Cancelled under subsection 41GN(1) of the Act

The sponsor failed to respond to a request for information and therefore failed to comply with an automatic condition of inclusion.

Date of effect: 23 Nov 2020

Owen Kelly & Associates

Product name/ARTG reference: Surgical/examination garment kit [61938]

ARTG number: 338634

Type of regulatory action: Cancelled under subsection 41GN(1) of the Act

The sponsor failed to respond to a request for information and therefore failed to comply with an automatic condition of inclusion.

Date of effect: 20 Nov 2020

Dento-Medical Trade Corp

Product name/ARTG reference: Dental implant suprastructure device, permanent

ARTG number: 282220

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

The sponsor has failed to comply with an automatic condition of inclusion applied to this ARTG entry under subsection 41FN(5A) of Therapeutic Goods Act 1989 and regulation 5.11 of Therapeutic Goods (Medical Devices) Regulations 2002, to provide information about the safety and performance of the Devices by 1 October each year for three consecutive years after the inclusion.

Date of effect: 20 Nov 2020

Durrenmatt-Folk Trading Pty Ltd / Fujian Hanhe Nursing Products Co Ltd

Product name/ARTG reference: Airway protection face mask / GMDN 18094

ARTG number: 331768

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

Failure to comply with a condition of inclusion

Date of effect: 16 Nov 2020

ULA Group Pty Ltd

Product name/ARTG reference: Ultraviolet room disinfection system [62893]

ARTG number: 343319

Type of regulatory action: Cancellation under s41GN(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, that the Product in question is a medical device, is incorrect.

Date of effect: 6 Nov 2020

Promotek Pty Ltd

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

ARTG number: 335205

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(2) of the Act.

Medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia

Date of effect: 6 Nov 2020

Promotek Pty Ltd

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

ARTG number: 334848

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(2) of the Act.

Medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia

Date of effect: 6 Nov 2020

AirSmart Pty Ltd

Product name/ARTG reference: Air cleaner high-efficiency filter, stationary [36296]

ARTG number: 342903

Type of regulatory action: Cancellation under s41GN(1) of the Act.

The product is not a therapeutic good/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: 6 Nov 2020

Baird Technology Pty Ltd

Product name/ARTG reference: Ultraviolet room disinfection system [62893]

ARTG number: 343082

Type of regulatory action: Cancellation under s41GN(1) of the Act.

The product is not a therapeutic good/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: 6 Nov 2020

Thunderstorm Scientific Pty Ltd

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

ARTG number: 340297

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

Non response to a s41JA

Date of effect: 6 Nov 2020

Thunderstorm Scientific Pty Ltd

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

ARTG number: 340401

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

Non response to a s41JA

Date of effect: 6 Nov 2020

Histar Tradings Pty Ltd

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

ARTG number: 333945

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

Non response to a s41JA

Date of effect: 6 Nov 2020

Histar Tradings Pty Ltd

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

ARTG number: 332835

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

Non response to a s41JA

Date of effect: 4 Nov 2020

The Dermaceutical Lab Pty Ltd

Product name/ARTG reference: Electronic cosmetic micro-needling handpiece [61216]

ARTG number: 333762

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

The sponsor failed to comply with a notice under section 41JA of the Act and therefore failed to comply with an automatic condition of inclusion under s41FN(3)(c)of the Act.

Date of effect: 3 Nov 2020

Melbourne Biotech

Product name/ARTG reference: 'Infectious disease IVDs'

ARTG number: 335991

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

The sponsor failed to comply with the conditions of inclusion stipulated under paragraph 41FN of the Therapeutic Goods Act 1989.

Date of effect: 3 Nov 2020

Emind Pty Ltd

Product name/ARTG reference: Face splash shield, reprocessed [64850]

ARTG number: 335978

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

The sponsor failed to provide information requested by the TGA under section 41JA of the Act. The sponsor therefore failed to comply with an automatic condition of inclusion (s41FN(3)(c) of the Act).

Date of effect: 3 Nov 2020

Pluspak Safety Pty Ltd

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

ARTG number: 340192

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

The sponsor failed to provide information requested by the TGA under section 41JA of the Act. The sponsor therefore failed to comply with an automatic condition of inclusion (s41FN(3)(c) of the Act).

Date of effect: 2 Nov 2020

Adamar Australia Pty Ltd

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

ARTG number: 337180

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

Non response to a s41JA

Date of effect: 28 Oct 2020

Brand Developers Australia Pty Ltd

Product name/ARTG reference: Ultraviolet room disinfection system [62893]

ARTG number: 342669

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

The product is an excluded good for the purposes of the Act, that is, the product is determined not to be a therapeutic good. Therefore the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion, that the product is a medical device, is incorrect.

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