Publication of Cancellation of Entries for Kinds of Medical Devices from the Australian Register of Therapeutic Goods – Pacific Medistim Pty Ltd - 137247

Overview

The Therapeutic Goods Act 1989 (the Act) was introduced to regulate the supply of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act is administered by the Therapeutic Goods Administration, an agency of the Australian Government Department of Health. One of the key functions of the Act is to maintain the Australian Register of Therapeutic Goods (ARTG), which lists all therapeutic goods that are permitted to be supplied in Australia. Section 41GP of the Act provides the mechanism for the cancellation of entries from the ARTG when certain conditions are met, such as when certifications related to the therapeutic goods are found to be incorrect or no longer correct in a material particular. This legislative provision ensures that only therapeutic goods meeting the required standards are available for supply in Australia, thereby protecting public health. In this particular instance, an entry for a kind of medical device, specifically a transcutaneous electrical nerve stimulation (TENS) device manufactured by Pacific Medistim Pty Ltd, was cancelled from the ARTG. The cancellation was made by Dr. Jane Cook, a delegate of the Secretary to the Department of Health and Ageing, on 7 January 2013, and took effect on 18 January 2013. The decision to cancel the entry was based on the delegate's satisfaction that certifications related to the TENS device were incorrect or no longer correct in a material particular, as stipulated under paragraph 41GN(1)(f) of the Act. This action reinforces the importance of maintaining accurate and up-to-date information in the ARTG, ensuring that only therapeutic goods that meet the necessary standards are available for supply in Australia.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, and under section 41GP, specific entries for kinds of medical devices can be cancelled from the Australian Register of Therapeutic Goods (ARTG). This particular legislation applies to the cancellation of entries for medical devices, specifically the removal of a listing for a transcutaneous electrical nerve stimulation (TENS) device used for analgesic purposes from the ARTG. The cancellation was ordered by Dr. Jane Cook, acting as a delegate of the Secretary to the Department of Health and Ageing, who determined that the certifications related to the device’s inclusion in the ARTG were incorrect or no longer accurate in material respects. The application of this Act is confined to the Commonwealth of Australia and pertains to entities and medical devices that are subject to the Therapeutic Goods Act 1989. There are no specified exclusions or exemptions mentioned in this excerpt, though the Act itself may contain provisions for these under other sections. The scope of the Act is further extended or refined through subordinate instruments, such as regulations and guidelines, which are not detailed in this specific publication but are integral to the administration of the Act.

Key Provisions

The main operative sections of the legislation, section 41GP of the Therapeutic Goods Act 1989 (the Act), detail the process for the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). Specifically, this section empowers the delegate of the Secretary to the Department of Health and Ageing to publish particulars of the cancellation of entries from the ARTG under certain circumstances, such as when certifications related to the inclusion of a medical device in the register are found to be incorrect or no longer correct in a material particular (subsection 41GN(1)(f)). In this instance, the delegate, Dr Jane Cook, has exercised this authority to cancel the entry for the peripheral nerve stimulator, electrical, analgesic, transcutaneous, with ARTG number 137247, sponsored by Pacific Medistim Pty Ltd. Under this Act, entities such as Pacific Medistim Pty Ltd, which have a medical device listed in the ARTG, are required to ensure that all certifications related to the inclusion of their devices are accurate and up-to-date. These certifications must comply with the provisions outlined in sections 41FD(d), 41FD(e), and 41FN(3) of the Act. Failure to maintain accurate certifications can result in the cancellation of the device's entry from the ARTG, as observed in this case. The Act mandates that any party wishing to include a medical device in the ARTG must adhere to the stipulated certification requirements and maintain the accuracy of these certifications at all times. Breaching the requirements of the Therapeutic Goods Act 1989 can lead to serious consequences. Under this Act, the delegate of the Secretary has the authority to cancel entries from the ARTG when it is determined that certifications related to a medical device are incorrect or no longer correct in a material particular. This cancellation effectively removes the device from the ARTG, potentially impacting its availability and use within Australia. Furthermore, while the Act does not specify particular offences or penalties for such breaches, the cancellation of an entry serves as a significant consequence, reflecting the importance of compliance with the Act's provisions. The precise legal ramifications of non-compliance, including any potential civil or criminal penalties, would be determined by the courts in the context of any legal proceedings arising from such breaches.