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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 201 - 225 of 507

2020

Date of effect: 30 Sep 2020

Amandla China Pty Limited

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

ARTG number: 334414

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

Non response to a s41JA

Date of effect: 28 Sep 2020

Accurex Australia Pty Ltd

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

ARTG number: 340184

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 23 Sep 2020

River Stone Fish Farm

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

ARTG number: 335700

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 18 Sep 2020

Big Start Pty Ltd

Product name/ARTG reference: Moister chamber goggles[40566]

ARTG number: 335462

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: 18 Sep 2020

Biosafety Pty Ltd

Product name/ARTG reference: Light, germicidal, ultraviolet[35150]

ARTG number: 306298

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: 16 Sep 2020

Sweet As Enterprise

Product name/ARTG reference: Mask, surgical, single use / 35177

ARTG number: 334193

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

Devices of that kind are no longer therapeutic goods.

Date of effect: 16 Sep 2020

Promedical Equipment Pty Ltd

Product name/ARTG reference: 2019-nCov Ab Test (Colloidal Gold)

ARTG number: 333090

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

The certifications made by the sponsor under section 41FD of the Therapeutic Goods Act 1989 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.

Date of effect: 4 Sep 2020

Imex Global Partners Pty Ltd.

Product name/ARTG reference: Public N95 Respirator [57793]

ARTG number: 333714

Type of regulatory action: Cancellation from the ARTG under subsection 41GL(e) 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 was false or misleading in a material particular

Date of effect: 2 Sep 2020

Envirofluid

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

ARTG number: 338259

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 2 Sep 2020

Envirofluid

Product name/ARTG reference: Disinfectant hospital grade [9950]

ARTG number: 338262

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 1 Sep 2020

CLO2 SOLUTIONS

Product name/ARTG reference: Disinfectant hospital grade [9950]

ARTG number: 337995

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 1 Sep 2020

Isochem Australia Pty Limited

Product name/ARTG reference: Disinfectant hospital grade [9950]

ARTG number: 336830

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 1 Sep 2020

Medispec Australia Pty Ltd

Product name/ARTG reference: Disinfectant hospital grade [9950]

ARTG number: 336824

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 1 Sep 2020

Medispec Australia Pty Ltd

Product name/ARTG reference: Medical device aerosol disinfectant [58082]

ARTG number: 336702

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 31 Aug 2020

Durr Dental SE

Product name/ARTG reference: Combination water purification system [44344]

ARTG number: 329059

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 28 Aug 2020

More Group Pty Ltd

Product name/ARTG reference: Dental implant suprastructure device, permanent [44879]

ARTG number: 214787

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: 28 Aug 2020

Minimax Implant Pty Ltd

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

ARTG number: 337115

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 28 Aug 2020

CARINDA HEALTH PTY LIMITED

Product name/ARTG reference: Air cleaner, high-efficiency filter, mobile[18113]

ARTG number: 3357885

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 25 Aug 2020

Alpro Medical Australia Pty Limited

Product name/ARTG reference: Medical device decontamination agent [63385]

ARTG number: 334965

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 18 Aug 2020

Saniflex Pty Ltd

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

ARTG number: 337665

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 18 Aug 2020

Intertrade Group Pty Ltd

Product name/ARTG reference: Disinfectant, hospital grade [9950]

ARTG number: 337543

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 14 Aug 2020

Precision Metal Group Aust

Product name/ARTG reference: Washer, decontamination/sanitizing [35318]

ARTG number: 334586

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 14 Aug 2020

Able Holdings (Aust) Pty Ltd atf Able Group Family Trust t/a Able Scientific

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

ARTG number: 317883

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 14 Aug 2020

Wilhelm Integrated Solutions

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

ARTG number: 331201

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

Date of effect: 14 Aug 2020

IC Disinfection Pty Ltd

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

ARTG number: 324884

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(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 in the application for inclusion is incorrect.

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