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Medical devices and IVDs: Suspensions from the ARTG

14 November 2019

Following a review by the TGA, medical devices (including IVDs) can be suspended from the Australian Register of Therapeutic Goods. These suspensions are made by the Secretary under section 41GA of the Therapeutic Goods Act 1989.

Medical devices and IVDs can also be suspended from the ARTG if the conformity assessment certificate applying to that kind of device is suspended under section 41GF.

If a suspension occurs because of a safety concern, the TGA considers whether other actions including a recall are necessary and takes those actions when required. Any related safety alerts will appear under 'Further information'.

The reasons for a suspension are stated in the database under 'Grounds for suspension'.

The heading 'Decision status' provides updated information about a suspension, for example, a decision to extend the suspension, or information about any decision to revoke a suspension decision. It will not appear in every entry.

Medical devices and IVD suspensions

Displaying 51 - 64 of 64

2015

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Mammary Implant-Silicone Gel-Smooth Surface - Prosthesis, internal, mammary, gel filled

ARTG number: 148764

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, testicle

ARTG number: 144004

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Mammary Implant - Silicone Gel - Textured Surface - Prosthesis, internal, mammary, gel filled

ARTG number: 148763

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Balloon, gastric, appetite-suppressing

ARTG number: 143651

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, tendon sheath

ARTG number: 147759

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, band, gastroplasty

ARTG number: 143181

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, joint, digit

ARTG number: 147758

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Tissue reconstructive material, synthetic, silicone, block

ARTG number: 143152

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Dressing, occlusive, silicone

ARTG number: 145286

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Tissue reconstructive material, synthetic, silicone, sheet

ARTG number: 143151

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

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

2014

Suspension start date: 23 May 2014

Suspension end date: 21 Nov 2014

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference: Sizer, mammary prosthesi

ARTG number: 162029

Type of regulatory action: Suspended from the ARTG under s. 41GA(1)(b) of the Act

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information:

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Suspension start date: 23 May 2014

Suspension end date: 21 Nov 2014

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference: Cereform Optima Silicone Gel-Filled Breast Implant

ARTG number: 165462

Type of regulatory action: Suspended from the ARTG under s. 41GA(1)(b) of the Act

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information:

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Suspension start date: 23 May 2014

Suspension end date: 21 Nov 2014

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference: Cereform Silicone Gel-Filled Breast Implant (Intermediate Texture)

ARTG number: 165461

Type of regulatory action: Suspended from the ARTG under s. 41GA(1)(b) of the Act

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information:

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Suspension start date: 23 May 2014

Suspension end date: 21 Nov 2014

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference: Cereform Silicone Gel-Filled Breast Implant (Smooth Texture)

ARTG number: 165460

Type of regulatory action: Suspended from the ARTG under s. 41GA(1)(b) of the Act

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information:

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

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