PUBLICATION OF CANCELLATION OF ENTRIES FOR KINDS OF MEDICAL DEVICES
FROM THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
SECTION 41GP OF THE THERAPEUTIC GOODS ACT 1989
I, Rodolfo Ferrari, delegate of the Secretary to the Department of Health and Ageing for the purposes of section 41GP of the Therapeutic Goods Act 1989 (the Act), hereby publish particulars of the cancellation of the following entry of a kind of medical device from the Australian Register of Therapeutic Goods under subsection 41GN(1)(f) of the Act:
ARTG entry of a kind of medical device: cryogenic spray, cutaneous
ARTG number: 197620
Sponsor: Device Technologies Australia Pty Ltd
Manufacturer: Occam Design (USA)
Decision Date: 16 July 2013
Date of Effect: 31 August 2013
Reason
The certifications made in the application to include this kind of device in the Register under section 41FD(c) of the Act is not correct in relation to the classification of this kind of device. The classification of the medical device in the ARTG Entry is incorrect.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
16 July 2013
Overview
The Therapeutic Goods Act 1989, as amended, is central to regulating therapeutic goods in Australia, ensuring they are safe and of high quality. The Act was introduced to address the need for a comprehensive legal framework to govern the supply, importation, and registration of therapeutic goods. Enacted by the Parliament of Australia, the Act aims to protect public health by ensuring that only safe and effective therapeutic goods are available in the market. The policy objective is to maintain high standards for therapeutic goods to safeguard health and safety. This particular legislative action, Gazette C2013G01119, pertains to the cancellation of an entry for a cryogenic spray, cutaneous device from the Australian Register of Therapeutic Goods (ARTG) due to an incorrect classification. The decision was made by Rodolfo Ferrari, acting as a delegate of the Secretary to the Department of Health and Ageing, and it became effective on 31 August 2013. The cancellation was necessitated by the inaccuracy in the certification provided for the inclusion of the device in the ARTG, underscoring the importance of precise classification for regulatory compliance.
Scope and Application
The scope of the Therapeutic Goods Act 1989 as referenced by section 41GP involves the regulation of therapeutic goods, including medical devices, within Australia. Specifically, this Act applies to the inclusion and subsequent cancellation of entries of kinds of medical devices in the Australian Register of Therapeutic Goods (ARTG). The Act governs entities such as sponsors and manufacturers of medical devices, including Device Technologies Australia Pty Ltd and Occam Design (USA) in this instance. The decision to cancel the entry for a cryogenic spray, cutaneous, from the ARTG pertains to the classification and certification of medical devices. This Act has a national reach across the Commonwealth of Australia, ensuring a standardised regulatory framework for therapeutic goods across all states and territories. The Act allows for exclusions and exemptions as specified within its provisions, but the provided excerpt does not detail any specific exclusions or thresholds related to this cancellation. Any further application or restrictions of this Act may be extended or clarified through subordinate instruments or regulations.
Key Provisions
The key operative section of this legislation is section 41GP of the Therapeutic Goods Act 1989, which pertains to the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). Under this section, the delegate of the Secretary to the Department of Health and Ageing has the authority to cancel an entry if it is determined that the certifications made in the application for inclusion in the Register are incorrect, specifically concerning the classification of the medical device. In this instance, the delegate has published the cancellation of an entry for a cryogenic spray, cutaneous device (ARTG number: 197620), manufactured by Occam Design (USA) and sponsored by Device Technologies Australia Pty Ltd, due to an incorrect classification of the device.
The Act imposes certain obligations on the parties involved, such as the sponsor and the manufacturer, to ensure that the certifications and classifications of medical devices are accurate and in compliance with the requirements of the Therapeutic Goods Act 1989. This includes providing truthful and complete information when applying for the inclusion of a medical device in the ARTG and ensuring that the classification of the device is correctly determined. Failure to meet these obligations may result in the cancellation of the entry for the medical device from the ARTG.
In the event of a breach of the obligations and requirements imposed by the Therapeutic Goods Act 1989, there may be civil or criminal consequences for the parties involved. However, the specific offences, penalties, or consequences are not outlined in the provided text. The maximum penalties for breaches of the Therapeutic Goods Act 1989 can vary depending on the nature and severity of the offence, and can include fines and imprisonment. It is important to consult the full Act and relevant case law for a comprehensive understanding of the potential penalties and consequences for breaches of the Act.