Notice of Particulars of Revocation of Conformity Assessment Certificates

Administered by Department of Health, Disability and Ageing

Legislation au C2017G00695 In force Gazette

Legislation content

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

 

NOTICE OF PARTICULARS OF REVOCATION OF CONFORMITY ASSESSMENT CERTIFICATES UNDER SECTION 41EV OF THE THERAPEUTIC GOODS ACT 1989

 

I, Cheryl McRae, a delegate of the Secretary of the Department of Health for the purpose of section 41EV of the Therapeutic Goods Act 1989 (the Act), provide notice of the following particulars relating to the revocation of the following conformity assessment certificates under section 41ES of the Act:

(a)   By written notice of revocation dated 25 August 2016, a delegate of the Secretary notified Teleflex Medical Australia Pty Ltd, the person in relation to whom Conformity Assessment Certificate AU Q00189 is taken to be issued pursuant to regulation 4.7 of the Therapeutic Goods (Medical Devices) Regulations 2002, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00189. The request for revocation follows the acquisition of Mayo Healthcare Pty Ltd (the company in relation to whom the Conformity Assessment Certificate AU Q00189 was issued) by Teleflex Australia in February 2014. The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Teleflex Medical Australia dated 29 July 2016.  The revocation took effect on 30 August 2016, being the day that the written notice of revocation was given to Teleflex Medical Australia Pty Ltd.

 

(b)  By written notice of revocation dated 25 August 2016, a delegate of the Secretary notified National Diagnostics Products Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00344 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00344.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from National Diagnostics Products Pty Ltd dated 1 August 2016. The revocation took effect on 30 August 2016, being the day that the written notice of revocation was given to National Diagnostics Products Pty Ltd.

 

(c)   By written notice of revocation dated 19 September 2016, a delegate of the Secretary notified ImpediMed Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00077 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00077.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from ImpediMed Ltd dated 12 September 2016.  The revocation took effect on 19 September 2016, being the day that the written notice of revocation was given to ImpediMed Ltd.

 

(d)  By written notice of revocation dated 11 January 2017, a delegate of the Secretary notified Micropace Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00070 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00070.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Micropace Pty Ltd dated 12 December 2016.  The revocation took effect on 13 January 2017, being the day that the written notice of revocation was given to Micropace Pty Ltd.

 

(e)   By written notice of revocation dated 6 February 2017, a delegate of the Secretary notified Johnson & Johnson Medical Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00069 (version 4) was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00069.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Johnson & Johnson Medical Pty Ltd dated 25 January 2017.  The revocation took effect on 6 February 2017, being the day that the written notice of revocation was given to Johnson & Johnson Medical Pty Ltd.

 

(f)    By written notice of revocation dated 24 February 2017, a delegate of the Secretary notified Edwards Lifesciences LLC, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00338 was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00338.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Edwards Lifesciences LLC dated 20 February 2017.  The revocation took effect on 24 February 2017, being the day that the written notice of revocation was given to Edwards Lifesciences LLC.

 

(g)   By written notice of revocation dated 30 March 2017, a delegate of the Secretary notified Cyclomedica Australia Pty Ltd, the manufacturer in relation to whom Conformity Assessment Certificate AU Q00061 (version 3.1) was issued, of the delegate’s decision to revoke Conformity Assessment Certificate AU Q00061.  The revocation was made under section 41ES of the Act in accordance with a written request for revocation from Cyclomedica Australia Pty Ltd dated 16 March 2017.  The revocation took effect on 4 April 2017, being the day that the written notice of revocation was given to Cyclomedica Australia Pty Ltd.

 

 

 

Signed by

 

 

Dr Cheryl McRae

Delegate of the Secretary

19   June 2017

 

Overview

The Therapeutic Goods Act 1989 was enacted by the Australian Parliament to provide a regulatory framework for therapeutic goods, including medicines, medical devices, and other health-related products. This legislation was introduced to address the need for a comprehensive and coordinated system to ensure that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. The Act establishes the Therapeutic Goods Administration (TGA) under the Department of Health, which is responsible for the regulation and oversight of therapeutic goods in the country. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are safe, effective, and of high quality. This is achieved through rigorous assessment, approval, monitoring, and enforcement processes to maintain the integrity of the therapeutic goods market. The Act also aims to facilitate access to therapeutic goods while ensuring that risks to public health are minimised.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods within Australia, encompassing a broad range of products such as medicines, medical devices, and blood and blood components. The Act applies to entities and individuals involved in the manufacturing, importing, supplying, and advertising of therapeutic goods, and it operates on a Commonwealth level, with jurisdiction extending across the entire nation. The Act provides for the assessment and control of therapeutic goods to ensure their safety, quality, and efficacy, and it includes provisions for the certification and conformity assessment of medical devices. The Act may be subject to amendments and extensions through subordinate instruments, allowing for the incorporation of new scientific evidence and technological advancements. The Act does not apply to goods that are exempt under specific provisions, such as those used for personal, non-commercial purposes, or where an alternative regulatory scheme is applicable. The revocation of conformity assessment certificates under section 41EV of the Therapeutic Goods Act 1989 applies to entities that have had their certificates revoked following a written request and notice from the relevant delegate. The revocation process is specific to the entities named in the notice, such as Teleflex Medical Australia Pty Ltd, National Diagnostics Products Pty Ltd, and others, and it follows the acquisition or other circumstances that lead to the request for revocation. The revocation of these certificates means that the entities are no longer authorised to use the certificates as evidence of compliance with the requirements for medical devices in Australia. The revocation is effective from the date the written notice is given, and it signifies the cessation of the entity's ability to market their products under the authority of the revoked certificates.

Key Provisions

The Therapeutic Goods Act 1989, under section 41ES, allows for the revocation of conformity assessment certificates, which are crucial for the certification of therapeutic goods. These certificates are issued to manufacturers who meet the necessary standards for their products, and the revocation process is outlined in section 41EV. In this notice, Cheryl McRae, a delegate of the Secretary, details the revocation of several conformity assessment certificates. For instance, Conformity Assessment Certificate AU Q00189, issued to Teleflex Medical Australia Pty Ltd, was revoked following a written request dated 29 July 2016, with the revocation taking effect on 30 August 2016. Similarly, certificates AU Q00344, AU Q00077, AU Q00070, AU Q00069, AU Q00338, and AU Q00061 (version 3.1) were revoked in accordance with written requests from the respective companies and took effect on the dates the notices were given. The obligations imposed by the Act on the entities governed by it include maintaining the standards required for the issuance of conformity assessment certificates and promptly responding to requests for revocation if they wish to have their certificates revoked. The companies must ensure they meet all regulatory requirements and maintain accurate records of their certifications and any actions taken regarding them. This includes submitting written requests for revocation when appropriate and ensuring that such requests are processed within the stipulated timelines. Breaches of the provisions under the Therapeutic Goods Act 1989 can result in various consequences. For instance, knowingly supplying therapeutic goods that do not meet the required standards can lead to significant penalties. The Act provides for both civil and criminal penalties, with the specifics depending on the nature and severity of the breach. Civil penalties can include fines up to a certain amount determined by the court, while criminal penalties can result in imprisonment for individuals found guilty of serious offences. The exact penalties depend on the specific provisions breached and the context of the offence.

Legal classification tags

Area of Law
Regulatory Standards
Instrument
Gazette Notice
Concepts
Regulatory Standards
Reporting & Disclosure Obligations
Enforcement Powers

Interactions

Authorises

All Versions

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.