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Medical devices and IVDs: Cancellations from the ARTG

6 July 2020

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 230

2020

Date of effect: 3 Jul 2020

Laser Body Pty Ltd

Product name/ARTG reference: Hair-removal diode laser system [58786]

ARTG number: 317615

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

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

Date of effect: 29 Jun 2020

Novapharm Research (Australia) Pty Ltd

Product name/ARTG reference: Novapharm Research (Australia) Pty Ltd - Hospital Grade Disinfectants, with Non-Specific Claims, 'Benzalkonium Chloride'

ARTG number: 159751

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Ebos Group Australia Pty Ltd

Product name/ARTG reference: Ebos Group Australia Pty Ltd - TUFFIE 5 wipes - Hosptial Grade Disinfectants, with Non-Specific Claims, Non-Sterile

ARTG number: 165776

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Novapharm Research (Australia) Pty Ltd

Product name/ARTG reference: Novapharm Research (Australia) Pty Ltd, Asepti Active 24/7, Hospital grade disinfectant without claims, non-sterile

ARTG number: 218203

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Novapharm Research (Australia) Pty Ltd

Product name/ARTG reference: Novapharm Research (Australia) Pty Ltd, Hospital Grade Disinfectants, ‘benzalkonium chloride’ with Non-Specific Claims, Non-Sterile

ARTG number: 300207

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

National Compliance Australia

Product name/ARTG reference: National Compliance Australia - Not applicable - Disinfectant, hospital grade

ARTG number: 312131

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Steri-7 Pty Ltd

Product name/ARTG reference: Steri-7 Pty Ltd - S-7 Wipes Soft Pack - Disinfectant, hospital grade

ARTG number: 250032

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Onboard Solutions Pty Ltd

Product name/ARTG reference: Onboard Solutions Pty Ltd - Actril Hospital Grade Disinfectant – no claims- non sterile - Disinfectant, hospital grade

ARTG number: 282733

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Interclean Australasia Pty Ltd

Product name/ARTG reference: Interclean Australasia Pty Ltd, Hospital Grade Disinfectants, with Non-Specific Claims, ‘N,N-bis(3-aminopropyl) dodecylamine, Non-sterile

ARTG number: 289645

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Eucalip Bio Chemical Group Pty Ltd

Product name/ARTG reference: EUCALIP BIO-CHEMICAL GROUP DISINFECTANTS, WITH NON-SPECIFIC CLAIMS NON-STERILE

ARTG number: 90768

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Jasol Australia

Product name/ARTG reference: Jasol Australia - Fincol - Disinfectant, hospital grade

ARTG number: 119084

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Jasol Australia

Product name/ARTG reference: Jasol Australia, Hospital Grade Disinfectants, with Non-Specific Claims, 'benzalkonium chloride', Non-sterile

ARTG number: 284352

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Textor Converting Pty Ltd

Product name/ARTG reference: Textor Converting Pty Ltd - Hospital Grade Disinfectants, with Non-Specific Claims, '70%v/v Isopropyl alcohol, Non-sterile'

ARTG number: 216656

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 29 Jun 2020

Jasol Australia

Product name/ARTG reference: Jasol Australia, Hospital Grade Disinfectant, with Non-Specific Claims, 'Sodium hypochlorite, Sodium hydroxide', Non-sterile

ARTG number: 279786

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

Grounds for cancellation The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 26 Jun 2020

Jasol Australia

Product name/ARTG reference: Jasol Australia, Hospital Grade Disinfectant, with Non-Specific Claims, 'Sodium hypochlorite', Non-sterile

ARTG number: 279787

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 25 Jun 2020

Ecolab Pty Ltd

Product name/ARTG reference: Ecolab Pty Ltd - Actichlor Plus, Hospital Grade with Non-Specific claims, "Sodium dichloroisocyanurate"

ARTG number: 174320

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 25 Jun 2020

Caronlab Australia Pty Ltd

Product name/ARTG reference: Caronlab Australia Pty Ltd, Hospital Grade Disinfectants, with Non-Specific Claims, 'Lactic acid, Malic acid, citric acid,Non-sterile

ARTG number: 279402

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 25 Jun 2020

Fresche Bioscience Pty Ltd

Product name/ARTG reference: Fresche Bioscience Pty Ltd, Hospital Grade Disinfectants, 'benzalkonium chloride' and 'didecyl dimethyl ammonium chloride', with Non-Specific Claims, Non-Sterile

ARTG number: 299500

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 25 Jun 2020

Agar Cleaning Systems Pty Ltd

Product name/ARTG reference: Agar Cleaning Systems Pty Ltd - Chloradet, Hospital Grade Disinfectant with Non-Specific Claims, Non-Sterile, "Sodium Hypochlorite and Sodium Hydroxide"

ARTG number: 166219

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 25 Jun 2020

Sterri-Matt Pty Ltd

Product name/ARTG reference: Sterri-Matt Pty Ltd - Gienie clinical - Disinfectant, hospital grade

ARTG number: 228834

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 23 Jun 2020

Zenpharm Pty Ltd

Product name/ARTG reference: COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)-ICOV421

ARTG number: 333881

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

The sponsor failed to fully comply with a request for information under s41JA and therefore failed to comply with a condition of inclusion under subsection 41FN(2) of the Act.

Date of effect: 19 Jun 2020

Orion Laboratories Pty Ltd T/A Perrigo Australia

Product name/ARTG reference: Orion Laboratories Pty Ltd T/A Perrigo Australia - Alcohol 70% untinted - Disinfectant, hospital grade

ARTG number: 125639

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 19 Jun 2020

SC Johnson & Son Pty Ltd

Product name/ARTG reference: SC Johnson & Son Pty Ltd - Duck Power Odour Elimination Lime & Vinegar - Disinfectant, hospital grade

ARTG number: 152287

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 19 Jun 2020

Orion Laboratories Pty Ltd T/A Perrigo Australia

Product name/ARTG reference: Orion Laboratories Pty Ltd T/A Perrigo Australia - Special Methylated Spirit 70% untinted - Disinfectant, hospital grade

ARTG number: 125642

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

Date of effect: 19 Jun 2020

Thermo Fisher Scientific Australia Pty Ltd

Product name/ARTG reference: Hosptial Grade Disinfectants, with Non-Specific Claims, 'Isopropyl Alcohol'

ARTG number: 156754

Type of regulatory action: Cancelled from the ARTG in accordance with paragraph 30(1)(b) of the Therapeutic Goods Act 1989

The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act).

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