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)(c) of the Act:
ARTG entry of a kind of medical device: Irrigation/aspiration unit, endoscopic
ARTG number: 196700
Sponsor: A & A Lifetech Pty Ltd t/a Eisner Australia
Manufacturer: RZ medizintechnik GmbH (Germany)
Date cancelled: 8 March 2013
Date of effect of cancellation: 17 April 2013
Reason:
The certification made in the application to include this kind of device in the Register concerning the classification of the device was not correct because the device is of a higher classification.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
8 March 2013
Overview
The Therapeutic Goods (Cancellation of Entry for Kinds of Medical Devices) Notice 2013 was published under section 41GP of the Therapeutic Goods Act 1989. This notice, issued by Rodolfo Ferrari, a delegate of the Secretary to the Department of Health and Ageing, provides details regarding the cancellation of an entry for a specific kind of medical device from the Australian Register of Therapeutic Goods (ARTG). The Act, enacted in 1989, was introduced to regulate therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The cancellation of the ARTG entry for an endoscopic irrigation/aspiration unit, manufactured by RZ medizintechnik GmbH and sponsored by A & A Lifetech Pty Ltd trading as Eisner Australia, was necessitated by an incorrect classification certification in the application. The cancellation took effect on 17 April 2013, addressing the discrepancy in the device's classification. This action underscores the regulatory body's commitment to maintaining the integrity of the ARTG by ensuring all listed therapeutic goods meet the appropriate standards and classifications.
Scope and Application
The Therapeutic Goods Act 1989 (the Act), through section 41GP, outlines the process for the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). The Act applies to any medical devices and their sponsors, manufacturers, and importers who seek inclusion in the ARTG. This includes any person or entity involved in the supply or use of medical devices within Australia. The Act has a national jurisdictional reach, applying across the Commonwealth of Australia, and is administered by the Department of Health and Ageing. The scope of the Act includes the regulation of therapeutic goods, including medical devices, to ensure they meet specific safety, quality, and performance standards before they can be supplied in Australia. The Act provides mechanisms for the cancellation of ARTG entries if the certification provided in the application for inclusion was incorrect, such as in cases where a device is misclassified. The exclusions and exemptions from the Act are minimal, with the primary exclusion being those therapeutic goods not intended for use in Australia. The Act may extend its application through subordinate instruments, such as regulations and guidelines, which provide further detail on the processes and requirements for the inclusion and cancellation of entries in the ARTG.
Key Provisions
The key provision of this legislation is the cancellation of an entry for a kind of medical device from the Australian Register of Therapeutic Goods (ARTG). Specifically, section 41GP of the Therapeutic Goods Act 1989 allows for the cancellation of such entries under certain conditions. In this instance, the cancellation pertains to an irrigation/aspiration unit, endoscopic, with the ARTG number 196700. The sponsor of this device is A & A Lifetech Pty Ltd t/a Eisner Australia, and the manufacturer is RZ medizintechnik GmbH from Germany. The cancellation was initiated by Rodolfo Ferrari, a delegate of the Secretary to the Department of Health and Ageing, under subsection 41GN(1)(c) of the Act, due to an incorrect certification regarding the device's classification.
This Act imposes certain obligations on the parties involved, particularly the sponsor and the manufacturer. The sponsor, A & A Lifetech Pty Ltd, must ensure that all entries in the ARTG are correctly classified and that any certifications made in applications are accurate. Similarly, the manufacturer, RZ medizintechnik GmbH, is responsible for providing correct and complete information about the device to support its inclusion in the ARTG. Both parties must comply with the Therapeutic Goods Act 1989 and any associated regulations, ensuring that the devices they market meet the required safety and efficacy standards.
The Act does not explicitly outline specific offences, penalties, or consequences for breaches related to the cancellation of an ARTG entry due to incorrect certification. However, breaches of the Therapeutic Goods Act 1989 can lead to various civil and criminal penalties. For instance, under section 42DA of the Act, a person who contravenes certain provisions can be subject to fines of up to $2,200,000 for a corporation and up to $440,000 for an individual, along with potential imprisonment terms. Additionally, the Act allows for the cancellation of ARTG entries, which can result in the cessation of the sale and distribution of the affected medical devices, thereby impacting the businesses involved. The seriousness of the consequences often depends on the nature and extent of the breach, and authorities may take enforcement actions to ensure compliance with the legislative requirements.