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Cancellation of Registration/Listing/Inclusion of Goods in the Australian Register of Therapeutic Goods - 20 June 2013

Cancellation of Registration/Listing/Inclusion of Goods in the Australian Register of Therapeutic Goods - 20 June 2013

Administered by Department of Health, Disability and Ageing

Legislation au C2013G00915 In force Gazette

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COMMONWEALTH OF AUSTRALIA

THERAPEUTIC GOODS ACT 1989

CANCELLATION OF REGISTRATION / LISTING / INCLUSION OF GOODS IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS

I, Nicole McLay, Delegate of the Secretary to the Department of Health and Ageing, hereby give notice that the entries in the Australian Register of Therapeutic Goods of the goods which are specified below were cancelled on the dates specified below under Section 41GL(f) of the Therapeutic Goods Act 1989.

The goods were cancelled because the sponsors of the goods did not pay the annual charges within 20 days after they became due.

SPONSOR NAME	ARTG NO	AUSTRALIAN REGISTER OF THERAPEUTIC GOODS NAME	DATE CANCELLED
DKSH Australia Pty Ltd	27122	EDWARD KELLER INVITRO DIAGNOSTICS OF HUMAN ORIGIN	17/06/2013
DKSH Australia Pty Ltd	27127	EDWARD KELLER INVITRO DIAGNOSTICS OF HUMAN ORIGIN	17/06/2013
DKSH Australia Pty Ltd	134878	DKSH Australia Pty Ltd - Bath, ultrasonic cleaning unit	17/06/2013
Torinat Pty Ltd	94003	Torinat Pty Ltd Compress, hot pack, moist heat	17/06/2013
Baribunma Holdings Limited	107449	Baribunma Holdings Limited - Wheelchair, occupant, power assisted, non-collapsible	20/05/2013
Lyzw Pty Ltd	148644	Lyzw - Drill, dental, gas powered handpiece	31/05/2013
Lyzw Pty Ltd	148841	Lyzw - Artificial teeth, resin	31/05/2013
Lyzw Pty Ltd	168120	Lyzw - Drill, dental, gas powered handpiece	31/05/2013
Lyzw Pty Ltd	168543	Lyzw - Supply unit, dental	31/05/2013
Lyzw Pty Ltd	179877	Lyzw Pty Ltd - Light, dental, polymerization activator	31/05/2013
Australian Dentists Practice Assistance Company Ltd T/A Adpac	122426	Australian Dentists Practice Assistance Company Ltd T/A Adpac - Glove, patient examination, latex	17/06/2013
Australian Dentists Practice Assistance Company Ltd T/A Adpac	122427	Australian Dentists Practice Assistance Company Ltd T/A Adpac - Glove, patient examination, non-latex	17/06/2013
Australian Dentists Practice Assistance Company Ltd T/A Adpac	129652	Australian Dentists Practice Assistance Company Ltd T/A Adpac - Needle, dental	17/06/2013
DIO Australia Pty Ltd	130666	DIO Australia Pty Ltd - Torque wrench, manual, dental	14/06/2013
DIO Australia Pty Ltd	130669	DIO Australia Pty Ltd - dental implant surgicla kit - Surgical procedure kit, dental, implant/prosthesis	14/06/2013
DIO Australia Pty Ltd	130675	DIO Australia Pty Ltd - Driver/extractor	14/06/2013
DIO Australia Pty Ltd	130676	DIO Australia Pty Ltd - Torque wrench, manual, dental	14/06/2013
DIO Australia Pty Ltd	130677	DIO Australia Pty Ltd - Dental implant, fixture	14/06/2013
DIO Australia Pty Ltd	131380	DIO Australia Pty Ltd - Dental implant suprastructure device, permanent	14/06/2013
Therapeutic Goods & Supplies Pty Ltd	155846	Therapeutic Goods & Supplies Pty Ltd - Adhesive strip,	20/05/2013
United Networks International UNI Pty Ltd	189586	United Networks International UNI Pty Ltd - Acupuncture unit, home use	20/05/2013
United Networks International UNI Pty Ltd	189587	United Networks International UNI Pty Ltd - Acupuncture unit, home use	20/05/2013
United Networks International UNI Pty Ltd	189588	United Networks International UNI Pty Ltd - Acupuncture unit, home use	20/05/2013
United Networks International UNI Pty Ltd	189589	United Networks International UNI Pty Ltd - Acupuncture unit, home use	20/05/2013
United Networks International UNI Pty Ltd	189590	United Networks International UNI Pty Ltd - Acupuncture unit, home use	20/05/2013
United Networks International UNI Pty Ltd	189609	United Networks International UNI Pty Ltd - Acupuncture unit, home use	20/05/2013
United Networks International UNI Pty Ltd	189610	United Networks International UNI Pty Ltd - Acupuncture unit, home use	20/05/2013
Maxitrade Pty Ltd	196114	Maxitrade Pty Ltd - Wristlet, patient	17/06/2013
IDS Dental Pty Ltd	174426	Innovative DS - Camera, video,	18/06/2013
IDS Dental Pty Ltd	179551	Innovative DS - Supply unit, dental	18/06/2013
IDS Dental Pty Ltd	198427	IDS Dental Pty Ltd - Camera, video,	18/06/2013
Worldmed Pty Ltd	172589	Worldmed Pty Ltd - Cosmetic phototherapy system, professional	17/06/2013
Smart Smile	179994	Smart Smile - Dental bleaching agent	17/06/2013
Westpat Pty Ltd	185093	Westpat Pty Ltd - Dental handpiece cleaning/lubricating unit, automatic	14/06/2013
Westpat Pty Ltd	185094	Westpat Pty Ltd - Bath, ultrasonic cleaning unit	14/06/2013
Westpat Pty Ltd	185095	Westpat Pty Ltd - Sealing unit, packaging	14/06/2013
Westpat Pty Ltd	185096	Westpat Pty Ltd - Water purification unit, distillation	14/06/2013
Westpat Pty Ltd	185097	Westpat Pty Ltd - Sterilization packaging, single use	14/06/2013
Westpat Pty Ltd	185113	Westpat Pty Ltd - Light, dental, polymerization activator	14/06/2013
Westpat Pty Ltd	185114	Westpat Pty Ltd - Dental handpiece cleaning/lubricating unit, automatic	14/06/2013
Westpat Pty Ltd	185115	Westpat Pty Ltd - Camera, video, surgical	14/06/2013
Westpat Pty Ltd	185116	Westpat Pty Ltd - Bath, ultrasonic cleaning unit	14/06/2013
Westpat Pty Ltd	186377	Westpat Pty Ltd - Artificial teeth, resin	14/06/2013
Westpat Pty Ltd	187644	Westpat Pty Ltd - Drill, dental, gas powered handpiece	14/06/2013
Westpat Pty Ltd	187645	Westpat Pty Ltd - Drill, dental, gas powered handpiece	14/06/2013
Westpat Pty Ltd	187814	Westpat Pty Ltd - Mixer, dental, amalgam	14/06/2013
Westpat Pty Ltd	188522	Westpat Pty Ltd - Vibrating dental retractor	14/06/2013
Westpat Pty Ltd	188524	Westpat Pty Ltd - Vibrating dental retractor tip	14/06/2013
Westpat Pty Ltd	189784	Westpat Pty Ltd - Drill motor, surgical, electrically-powered	14/06/2013
Westpat Pty Ltd	190147	Westpat Pty Ltd - Drill, dental, electrically powered handpiece	14/06/2013
Westpat Pty Ltd	190776	Westpat Pty Ltd - Bur, dental, diamond	14/06/2013
Give Life Pty Ltd	182169	Give Life Pty Ltd - Glove, patient examination, non-latex	17/06/2013
Give Life Pty Ltd	182200	Give Life Pty Ltd - Scissors, general-purpose	17/06/2013
Give Life Pty Ltd	182201	Give Life Pty Ltd - Bandage,	17/06/2013
Give Life Pty Ltd	182202	Give Life Pty Ltd - Adhesive tape,	17/06/2013
Give Life Pty Ltd	182218	Give Life Pty Ltd - Resuscitator face mask, single-use	17/06/2013
Give Life Pty Ltd	182224	Give Life Pty Ltd - Splint, mouldable	17/06/2013
Give Life Pty Ltd	185280	Give Life Pty Ltd - Tourniquet strap	17/06/2013
Give Life Pty Ltd	187958	Give Life Pty Ltd - First aid kit	17/06/2013
Jointown Healthcare Pty Ltd	186126	Jointown Healthcare Pty Ltd - Walking aid, one arm, stick, multiple support	14/06/2013
Jointown Healthcare Pty Ltd	186127	Jointown Healthcare Pty Ltd - Walking aid, one arm, stick	14/06/2013
Jointown Healthcare Pty Ltd	186128	Jointown Healthcare Pty Ltd - Walking aid, one arm, stick	14/06/2013
Jointown Healthcare Pty Ltd	186130	Jointown Healthcare Pty Ltd - Walking aid,	14/06/2013
Jointown Healthcare Pty Ltd	186153	Jointown Healthcare Pty Ltd - Chair, toilet	14/06/2013
Jointown Healthcare Pty Ltd	186154	Jointown Healthcare Pty Ltd - Pressure alleviation pad, air, alternating contact, system	14/06/2013
Jointown Healthcare Pty Ltd	186155	Jointown Healthcare Pty Ltd - Stethoscope, mechanical	14/06/2013
Jointown Healthcare Pty Ltd	186156	Jointown Healthcare Pty Ltd - Fixation system, external, head/neck	14/06/2013
Jointown Healthcare Pty Ltd	186157	Jointown Healthcare Pty Ltd - Wheelchair,	14/06/2013
Jointown Healthcare Pty Ltd	188254	Jointown Healthcare Pty Ltd - Nebulizer, non-heated	14/06/2013
Medisense Best Care Pty Ltd T/a Medisense Healthcare	192293	Medisense Best Care Pty Ltd T/a Medisense Healthcare - Lancet tip	17/06/2013
Medisense Best Care Pty Ltd T/a Medisense Healthcare	192422	Medisense Best Care Pty Ltd T/a Medisense Healthcare - Lancet, manual, single use	17/06/2013
Delta Homes Australia Pty Ltd	191087	Delta Homes Australia Pty Ltd - Stimulator, electrical, analgesic, peripheral nerve, transcutaneous	17/06/2013
World Shopping Bay Pty Ltd	198425	World Shopping Bay Pty Ltd - Absorbent, <specify>	14/06/2013
World Shopping Bay Pty Ltd	198559	World Shopping Bay Pty Ltd - Absorbent, <specify>	14/06/2013
Everlast Energy Solutions Pty Ltd	202505	Everlast Energy Solutions Pty Ltd - Heating pad, chemically-reactive gel	11/06/2013
Market Reach Pty Ltd	149062	Market Reach Pty Ltd - Filter, bacteria, suction unit	23/05/2013
Market Reach Pty Ltd	149323	Market Reach Pty Ltd - Suction unit, low pressure	23/05/2013

(Signed by)
Nicole McLay
Delegate of the Secretary to the Department of Health and Ageing

Chief Financial Officer

Office of Corporate Services
Regulatory Support Group

20 June 2013

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the quality, safety, and efficacy of therapeutic goods available in Australia. This Act provides a comprehensive framework for the registration, evaluation, and monitoring of therapeutic goods, including medicines, medical devices, and blood products. One of the key objectives of the Act is to ensure that therapeutic goods available to the public meet appropriate standards and are safe for use, thereby protecting public health. Under Section 41GL(f) of the Act, the Therapeutic Goods Administration, acting through a delegate, has the authority to cancel the registration of therapeutic goods if the sponsors fail to meet certain obligations, such as paying annual charges within the stipulated timeframe. This measure serves to maintain the integrity of the Australian Register of Therapeutic Goods and ensures that only those goods which meet the regulatory standards are available for use. The notice issued under the Act by Nicole McLay, Delegate of the Secretary to the Department of Health and Ageing, highlights the cancellation of the registration of various therapeutic goods due to non-payment of annual charges by the sponsors. This action underscores the importance of compliance with regulatory requirements to maintain the quality and safety of therapeutic goods in the Australian market. The cancellation of these goods from the Australian Register of Therapeutic Goods reflects the enforcement mechanisms provided by the Act to ensure that therapeutic goods meet the necessary standards and obligations.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, which encompass a wide range of products such as medicines, medical devices, blood, and tissues, that are regulated to ensure their safety, quality, and efficacy. The Act applies to the sponsors of these goods, which are entities or individuals responsible for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG). The Act has a national reach, governing the entire Commonwealth of Australia, including its states and territories. It provides a framework for the regulation of therapeutic goods and includes provisions for the cancellation of registrations or listings if annual charges are not paid within the stipulated timeframe. The Act may extend or restrict its application through subordinate instruments, such as regulations or guidelines, which provide further detail on the administration and enforcement of the Act. There are no specific exclusions or exemptions mentioned in the notice, but certain goods may be exempt under other provisions of the Act or regulations. The threshold for cancellation in this instance is the non-payment of annual charges within 20 days after they become due.

Key Provisions

The Therapeutic Goods Act 1989, as referenced in Section 41GL(f), outlines the procedures for the cancellation of registration, listing, or inclusion of goods in the Australian Register of Therapeutic Goods (ARTG). The cancellation of entries in the ARTG occurs when sponsors fail to pay the required annual charges within the stipulated period, which is 20 days after they become due. The notice published by Nicole McLay, acting as the Delegate of the Secretary to the Department of Health and Ageing, informs the public that specific entries in the ARTG have been cancelled due to non-payment of these charges. The list of cancelled goods includes a range of therapeutic products, from diagnostic kits to dental supplies, and extends to medical devices such as wheelchairs and nebulizers. The Act imposes several obligations on sponsors of therapeutic goods listed in the ARTG. Primarily, they must ensure timely payment of the annual charges to maintain the listing of their goods. Failure to comply with this requirement can result in the cancellation of the ARTG entry, effectively removing the goods from the market unless the sponsor takes corrective action to reinstate the listing. Sponsors are also responsible for ensuring that their products comply with the regulatory standards set out in the Therapeutic Goods Act and its associated regulations. This includes maintaining quality, safety, and efficacy, and being able to provide evidence of compliance upon request from the Therapeutic Goods Administration (TGA). Breaches of the Therapeutic Goods Act, such as failure to pay annual charges, can lead to the cancellation of ARTG entries, which is a significant regulatory consequence. While the notice does not specify the penalties for non-compliance beyond the cancellation of entries, the Therapeutic Goods Act generally provides for both civil and criminal penalties. Civil penalties can include fines and the requirement to pay compensation to affected parties. Criminal penalties may include imprisonment, especially in cases where the breach is deemed to have caused harm to public health or safety. The maximum penalties for offences under the Act can vary depending on the nature and severity of the breach. It is important for sponsors to be aware of these potential consequences and to ensure compliance with all regulatory requirements to avoid such penalties.

Area of Law: Medical Law
Instrument: Gazette Notice
Concepts: Definitions & Interpretation; Reporting & Disclosure Obligations; Enforcement Powers

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

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