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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 76 - 100 of 507

2021

Date of effect: 9 Feb 2021

DES Holdings Pty Ltd

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

ARTG number: 341912

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

Non response to a s41JA

Date of effect: 9 Feb 2021

Lway Trading Pty Ltd

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

ARTG number: 334257

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

Non response to a s41JA

Date of effect: 9 Feb 2021

Lway Trading Pty Ltd

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

ARTG number: 332990

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

Non response to a s41JA

Date of effect: 9 Feb 2021

Lway Trading Pty Ltd

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

ARTG number: 332989

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

Non response to a s41JA

Date of effect: 8 Feb 2021

Aidacare Pty Ltd

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

ARTG number: 333179

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

Non response to a s41JA

Date of effect: 8 Feb 2021

Aidacare Pty Ltd

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

ARTG number: 332604

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

Non response to a s41JA

Date of effect: 8 Feb 2021

Leigh Nails Supply Pty Ltd

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

ARTG number: 336141

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

Incomplete response to a s41JA

Date of effect: 5 Feb 2021

Iatric Solutions Pty Ltd

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

ARTG number: 333248

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

Non response to a section 41JA

Date of effect: 5 Feb 2021

Iatric Solutions Pty Ltd

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

ARTG number: 333249

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

Non response to a section 41JA

Date of effect: 5 Feb 2021

Melbourne Innovation Centre

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

ARTG number: 333929

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

Non response to a section 41JA

Date of effect: 5 Feb 2021

Melbourne Innovation Centre

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

ARTG number: 333791

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

Non response to a section 41JA

Date of effect: 5 Feb 2021

Melbourne Innovation Centre

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

ARTG number: 333092

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

Non response to a section 41JA

Date of effect: 5 Feb 2021

Melbourne Innovation Centre

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

ARTG number: 333094

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

Non response to a section 41JA

Date of effect: 5 Feb 2021

Melbourne Innovation Centre

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

ARTG number: 333095

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

Non response to a section 41JA

Date of effect: 3 Feb 2021

Koala Fund Pty Ltd

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

ARTG number: 335568

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

Non response to a s41JA

Date of effect: 29 Jan 2021

The Trustee for DKT Family Trust

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

ARTG number: 338931

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

Non response to a s41JA

Date of effect: 26 Jan 2021

ASA Hospitality Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 342067

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

Non response to a s41JA

Date of effect: 26 Jan 2021

ASA Hospitality Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 341092

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

Non response to a s41JA

Date of effect: 26 Jan 2021

ASA Hospitality Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 340875

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

Non response to a s41JA

Date of effect: 26 Jan 2021

ASA Hospitality Pty Ltd

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

ARTG number: 335456

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

Failure to comply with a condition of inclusion and and a certification made under 41FD(e) is incorrect in a material particular

Date of effect: 26 Jan 2021

ASA Hospitality Pty Ltd

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

ARTG number: 337385

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

Non response to a s41JA

Date of effect: 25 Jan 2021

Billhagen Pty Ltd

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

ARTG number: 333952

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

Non response to s41JA

Date of effect: 22 Jan 2021

Meditech Medical Supplies. Com

Product name/ARTG reference: Mask, <specify>

ARTG number: 334492

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

Failure to comply with a condition of inclusion, non- response to a s41JA, the safety and performance of the kind of Device is unacceptable and a certification made under 41FD(f) is incorrect in a material particular

Date of effect: 22 Jan 2021

ADKA Global Exports

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

ARTG number: 335543

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

Failure to comply with a condition of inclusion

Date of effect: 21 Jan 2021

JC Medical Group Pty Ltd

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

ARTG number: 283681

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

Non response to a s41JA

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