You are here

Medical devices and IVDs: Cancellations from the ARTG

24 January 2020

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:

Medical devices and IVD cancellations

Displaying 1 - 25 of 121

2020

Date of effect: 14 Jan 2020

Universal Medical Aesthetics

Product name/ARTG reference: Multi-modality skin surface treatment system, Thermo-mechanical skin surface treatment system, Hair removal diode laser system and skin photodynamic therapy/phototherapy lamp

ARTG number: 282331

Type of regulatory action: Cancelled from the ARTG under s41GM(2)(a)(i) and (b)(ii)

The Sponsor failed to comply to the notice under section 41JA within a further 10 working days from the date as specified in that notice.

Date of effect: 14 Jan 2020

Universal Medical Aesthetics

Product name/ARTG reference: Multi-modality skin surface treatment system, Thermo-mechanical skin surface treatment system, Hair removal diode laser system and skin photodynamic therapy/phototherapy lamp

ARTG number: 290725

Type of regulatory action: Cancelled from the ARTG under s41GM(2)(a)(i) and (b)(ii)

The Sponsor failed to comply to the notice under section 41JA within a further 10 working days from the date as specified in that notice.

Date of effect: 14 Jan 2020

Universal Medical Aesthetics

Product name/ARTG reference: Multi-modality skin surface treatment system, Thermo-mechanical skin surface treatment system, Hair removal diode laser system and skin photodynamic therapy/phototherapy lamp

ARTG number: 294985

Type of regulatory action: Cancelled from the ARTG under s41GM(2)(a)(i) and (b)(ii) Date of effect: 14 January 2020

The Sponsor failed to comply to the notice under section 41JA within a further 10 working days from the date as specified in that notice.

Date of effect: 14 Jan 2020

Universal Medical Aesthetics

Product name/ARTG reference: Multi-modality skin surface treatment system, Thermo-mechanical skin surface treatment system, Hair removal diode laser system and skin photodynamic therapy/phototherapy lamp

ARTG number: 317490

Type of regulatory action: Cancelled from the ARTG under s41GM(2)(a)(i) and (b)(ii) Date of effect: 14 January 2020

The Sponsor failed to comply to the notice under section 41JA within a further 10 working days from the date as specified in that notice.

Date of effect: 14 Jan 2020

Universal Medical Aesthetics

Product name/ARTG reference: Multi-modality skin surface treatment system, Thermo-mechanical skin surface treatment system, Hair removal diode laser system and skin photodynamic therapy/phototherapy lamp

ARTG number: 319826

Type of regulatory action: Cancelled from the ARTG under s41GM(2)(a)(i) and (b)(ii) Date of effect: 14 January 2020

The Sponsor failed to comply to the notice under section 41JA within a further 10 working days from the date as specified in that notice.

Date of effect: 14 Jan 2020

Universal Medical Aesthetics

Product name/ARTG reference: Multi-modality skin surface treatment system, Thermo-mechanical skin surface treatment system, Hair removal diode laser system and skin photodynamic therapy/phototherapy lamp

ARTG number: 278691

Type of regulatory action: Cancelled from the ARTG under s41GM(2)(a)(i) and (b)(ii)

The Sponsor failed to comply to the notice under section 41JA within a further 10 working days from the date as specified in that notice.

Date of effect: 10 Jan 2020

Tina Tran

Product name/ARTG reference: Cryolipolysis skin contouring system [62441]

ARTG number: 317611

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

The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.

2019

Date of effect: 27 Nov 2019

Alliance Surgical Pty Ltd

Product name/ARTG reference: Skin transilluminator, battery-powered [32696]

ARTG number: 307544

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

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to section 41JA

Date of effect: 18 Nov 2019

Acceledent Australia NZ

Product name/ARTG reference: orthodontic anchoring screw

ARTG number: 290178

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

As part of the conditions of inclusion the sponsor did not provide annual report information, the sponsor failed to comply with an automatic condition of inclusion under s41FN(5A) of the Act.

Date of effect: 12 Nov 2019

Enable Lifecare PTY LTD

Product name/ARTG reference: Scale accessory, weight [36020]

ARTG number: 317136

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

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to section 41JA.

Date of effect: 7 Nov 2019

Cryosculpt Australia

Product name/ARTG reference: Cryolipolysis body contouring system control unit [56308]

ARTG number: 318341

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

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to section 41JA

Date of effect: 5 Nov 2019

Global & Co Pty Ltd

Product name/ARTG reference: Intense pulsed light skin surface treatment system [58935]

ARTG number: 318044

Type of regulatory action: Cancelled from the ARTG under paragraph 41GN(1) of the Act

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to section 41JA.

Date of effect: 4 Nov 2019

McEvoy Legal

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

ARTG number: 321170

Type of regulatory action: Cancelled from the ARTG under paragraph 41GM(1) of the Act

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to section 41JA.

Date of effect: 20 Aug 2019

Australian Physiotherapy Equipment

Product name/ARTG reference: Ice Bag [12082]

ARTG number: 177216

Type of regulatory action: Cancelled from the ARTG in accordance with paragraphs 41GN(1)(c) and (f) of the Act

The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular.

Date of effect: 20 Aug 2019

Emery Industries Pty Ltd

Product name/ARTG reference: Trolley, <specify> [36995]

ARTG number: 134095

Type of regulatory action: Cancelled from the ARTG in accordance with paragraphs 41GN(1)(c) and (f) of the Act

The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular.

Date of effect: 20 Aug 2019

The Trustee for Pacific Medical Trust

Product name/ARTG reference: Trolley, supplying, instrument [34909]

ARTG number: 293100

Type of regulatory action: Cancelled from the ARTG in accordance with paragraphs 41GN(1)(c) and (f) of the Act

The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular.

Date of effect: 19 Aug 2019

Avention Global Pty Ltd

Product name/ARTG reference: Skin contouring system, radio-frequency [45219]

ARTG number: 309678

Type of regulatory action: Cancelled from the ARTG under paragraph 41GN(1) of the Act

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA Request for Information Notice.

Date of effect: 18 Jul 2019

Emergo Asia Pacific Pty Ltd T/a Emergo Australia Pty Ltd

Product name/ARTG reference: Light therapy unit, ultraviolet, home use [34669]

ARTG number: 155287

Type of regulatory action: Cancelled from the ARTG under paragraph 41GN(1) of the Act

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to section 41JA.

Date of effect: 16 Jul 2019

Nu Skin Enterprises Australia Inc

Product name/ARTG reference: Analyser, photometer, reflectance [35827]

ARTG number: 118126

Type of regulatory action: Cancelled from the ARTG under paragraph 41GN(1)(f) of the Act

The certification the sponsor made under section 41FD of the Act in relation to the application for inclusion of the kind of device in the Register is incorrect, or is no longer correct, in a material particular.

Date of effect: 16 Jul 2019

Zepter International Pty Ltd

Product name/ARTG reference: Light therapy unit, photo [35239]

ARTG number: 197700

Type of regulatory action: Cancelled from the ARTG under paragraph 41GN(1) of the Act

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA.

Date of effect: 12 Jul 2019

R & R Healthcare Equipment Pty Ltd

Product name/ARTG reference: Chair, [10787]

ARTG number: 209875

Type of regulatory action: Cancelled from the ARTG under paragraph 41GN(1) of the Act

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA

Date of effect: 2 Jul 2019

Avention Global Pty Ltd

Product name/ARTG reference: Cryolipolysis skin contouring system [62441]

ARTG number: 309677

Type of regulatory action: Cancelled from the ARTG under paragraph 41GN(1) of the Act

The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA letter.

Date of effect: 5 Jun 2019

Care Quip

Product name/ARTG reference: Walking Aid

ARTG number: 174393

Type of regulatory action: Cancelled from the ARTG under s41GN(1)(b)(c) and (f)

Information supplied to the TGA was insufficient to substantial compliance with Conformity Assessment procedures (s.41FN 3(a)) and the Essential Principles (s.41FN3(b)). Additionally, the sponsor did not comply with conditions of inclusion (s.41FN 3(c)) and false or misleading information was provided at the time of application (s.41FD (d)).

Date of effect: 17 May 2019

Crescent Healthcare Pty Ltd

Product name/ARTG reference: Trolley, supplying, linen/laundry

ARTG number: 206529

Type of regulatory action: Cancelled from the ARTG in accordance with paragraphs 41GN(1)(c) and (f) of the Therapeutic Goods Act 1989

The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular.

Date of effect: 17 May 2019

Action Bearings Pty Ltd

Product name/ARTG reference: Trolley, medical devices

ARTG number: 171326

Type of regulatory action: Cancelled from the ARTG in accordance with paragraphs 41GN(1)(c) and (f) of the Therapeutic Goods Act 1989

The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular.

Pages