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Medical devices and IVDs: Cancellations from the ARTG

7 November 2019

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 107

2019

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: 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.

Date of effect: 16 May 2019

Juvo Solutions Pty Ltd

Product name/ARTG reference: Trolley, medication

ARTG number: 257959

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: 16 May 2019

Juvo Solutions Pty Ltd

Product name/ARTG reference: Trolley, <specify>

ARTG number: 257957

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: 16 May 2019

Juvo Solutions Pty Ltd

Product name/ARTG reference: Trolley, general-purpose

ARTG number: 257958

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: 15 May 2019

Medical Devices Pty Limited

Product name/ARTG reference: Trolley, general-purpose

ARTG number: 140397

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: 3 May 2019

Medical Systems International Pty Ltd

Product name/ARTG reference: Specimen recepticle IVDs - Class I IVD

ARTG number: 217780

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

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: 29 Apr 2019

Caresentral Australia Pty Ltd

Product name/ARTG reference: Rayonex biofeedback system

ARTG number: 224787

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

The sponsor did not provide information or documents when required under a section 41JA notice.

Date of effect: 29 Apr 2019

Classic Pty Ltd

Product name/ARTG reference: E-Lybra Bio-energy mapping system

ARTG number: 310955

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

The sponsor did not provide information or documents when required under a section 41JA notice.

Date of effect: 27 Feb 2019

Allure Skincare

Product name/ARTG reference: Skin contouring system, multifunction [44832]

ARTG number: 286785

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

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: 20 Feb 2019

Grifols Australia Pty Ltd

Product name/ARTG reference: Procleix Ultrio Plus Assay - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ARTG number: 222720

Type of regulatory action: Cancelled from the ARTG under s41GK

The manufacturer requested in writing the revocation of their TGA conformity assessment certificates.

Date of effect: 20 Feb 2019

Grifols Australia Pty Ltd

Product name/ARTG reference: Procleix Ultrio Elite Assay - HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ARTG number: 275205

Type of regulatory action: Cancelled from the ARTG under s41GK

The manufacturer requested in writing the revocation of their TGA conformity assessment certificates.

2018

Date of effect: 6 Aug 2018

Hovans's Group Pty Ltd

Product name/ARTG reference: Stimulator [13762]

ARTG number: 190674

Type of regulatory action: Cancelled from the ARTG under paragraphs 41GN(1)(b) and 41GN(1)(f)

The certifications made by the sponsor under section 41FD in relation to the inclusion of the kind of device in the ARTG are incorrect in a material particular and the sponsor failed to comply with the conditions of inclusion stipulated under paragraph 41FN(3).

Date of effect: 20 Apr 2018

Profile Surgical Pty Ltd

Product name/ARTG reference: Forceps, biopsy

ARTG number: 186551

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

As 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: 4 Jan 2018

Coloplast Pty Ltd

Product name/ARTG reference: Mesh, polymeric, non-biodegradable (Altis Single Incision Sling)

ARTG number: 190173

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

Cancelled on the basis that the Secretary is satisfied that the safety and performance of the kind of device is unacceptable.

2017

Date of effect: 8 Nov 2017

Leading Asia Pacific Pty Ltd

Product name/ARTG reference: Massager, electrical, home use

ARTG number: 215075

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

The certifications the sponsor made under section 41FD of the Act in relation to the inclusion of the Device in the ARTG are incorrect in a material particular and the sponsor failed to comply with the conditions to which the inclusion of the Device is subject to.

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