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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 151 - 175 of 507

2020

Date of effect: 27 Oct 2020

Euro Implants Pty Ltd

Product name/ARTG reference: Cristaline Paragel Cohesive Gel Implant

ARTG number: 132037

Type of regulatory action: Cancellation from the ARTG under subsection 41GK of the Act.

The suspension of the Device from the ARTG was not revoked before the expiry date of the suspension.

Date of effect: 27 Oct 2020

JT Medical Pty Ltd

Product name/ARTG reference: Sublime Line, Microthane, Silicone gel filled Mammary Implants

ARTG number: 171782

Type of regulatory action: Cancellation from the ARTG under subsection 41GK of the Act.

The suspension of the Device from the ARTG was not revoked before the expiry date of the suspension.

Date of effect: 27 Oct 2020

JT Medical Pty Ltd

Product name/ARTG reference: 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants

ARTG number: 185060

Type of regulatory action: Cancellation from the ARTG under subsection 41GK of the Act.

The suspension of the Device from the ARTG was not revoked before the expiry date of the suspension.

Date of effect: 20 Oct 2020

Lionhawk Group Pty Ltd

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

ARTG number: 341170

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.

Date of effect: 19 Oct 2020

Life Biotech Pty Ltd

Product name/ARTG reference: Public respirator, single use

ARTG number: 333412

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

Non response to s41JA

Date of effect: 16 Oct 2020

Aurora Future Education Group

Product name/ARTG reference: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/ Serum/Plasma Combo)

ARTG number: 333901

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

The sponsor failed to provide information to comply with Essential principles of s41FN(3)(a), failed to provide evidence that device complies with conformity assessment procedures of s41FN(3)(b) and certifications made by the sponsor under section s41FC(2) 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.

Date of effect: 14 Oct 2020

Cardinal Health Australia 503 Pty Ltd

Product name/ARTG reference: Suction system tubing [16779]

ARTG number: 338121

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

The medical device is incorrectly classified. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect.

Date of effect: 12 Oct 2020

Parsa Global Import

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

ARTG number: 334089

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

Sponsor requested in writing the cancellation of the kind of device from the Register

Date of effect: 12 Oct 2020

Perfect Care Dental Pty Ltd

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

ARTG number: 334550

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

The safety and performance of the kind of device is unacceptable

Date of effect: 12 Oct 2020

Biovent Consulting Pty Ltd

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

ARTG number: 333081

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

Non response to a s41JA

Date of effect: 12 Oct 2020

Biovent Consulting Pty Ltd

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

ARTG number: 334953

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

Non response to a s41JA

Date of effect: 12 Oct 2020

Booming Australia Pty Ltd

Product name/ARTG reference: Public N95 respirator

ARTG number: 334099

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

Non response to a s41JA

Date of effect: 12 Oct 2020

Bradley John Lennox

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

ARTG number: 334195

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

Non response to a s41JA

Date of effect: 12 Oct 2020

BWRC

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

ARTG number: 333852

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

Non response to a s41JA

Date of effect: 9 Oct 2020

Protec Enviromental Group Pty

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

ARTG number: 334657

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

Non response to a s41JA

Date of effect: 9 Oct 2020

Beyond Bio Pty Ltd

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

ARTG number: 335920

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

Non response to a s41JA

Date of effect: 9 Oct 2020

Beyond Bio Pty Ltd

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

ARTG number: 336815

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

Non response to a s41JA

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334024

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334025

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Pluspak Safety Pty Ltd

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

ARTG number: 338402

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

The sponsor failed to provide information requested by the Secretary therefore the sponsor failed to comply with an automatic condition of inclusion under paragraph 41FN(3)(c) of the Act.

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334026

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Fasteners and More Pty Ltd

Product name/ARTG reference: Thermometer, infrared, skin [17888]

ARTG number: 335585

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

The sponsor failed to provide information requested by the Secretary therefore the sponsor failed to comply with an automatic condition of inclusion under paragraph 41FN(3)(c) of the Act.

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334027

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Imex Global Partners Pty Ltd.

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

ARTG number: 334339

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

Failure to comply with a request for information within the specified period

Date of effect: 7 Oct 2020

Concierge Contacts Pty Ltd

Product name/ARTG reference: Antiseptic swab [13913]

ARTG number: 336282

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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