Publication of Cancellation of Entries for Kinds of Medical Devices from the Australian Register of Therapeutic Goods – Active Mobility Systems - 164473 and 188718

Overview

The Therapeutic Goods (Australian Register of Therapeutic Goods) Amendment (2013 Measures No. 1) Regulations 2013, published under the Therapeutic Goods Act 1989, aim to address issues concerning the integrity and accuracy of entries in the Australian Register of Therapeutic Goods (ARTG). Enacted by the Governor-General under the authority of the Commonwealth of Australia, these regulations introduce measures to ensure that the ARTG reflects accurate and up-to-date information about therapeutic goods, including medical devices. Specifically, this legislative instrument empowers the Secretary to the Department of Health to cancel entries from the ARTG when there is evidence that the certifications related to these entries are incorrect or no longer correct in a material way. The underlying policy objective is to maintain the safety, quality, and efficacy of therapeutic goods available in Australia, thereby protecting public health. On 26 February 2013, Dr. Jane Cook, as the delegate of the Secretary to the Department of Health and Ageing, published the cancellation of entries for Patient Lifters from the ARTG. The decision was based on the finding that the certifications for these medical devices were incorrect or no longer correct in a material particular. This action underscores the commitment of the Australian government to rigorously manage the therapeutic goods market and ensure compliance with the standards set forth in the Therapeutic Goods Act 1989.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of medical devices and therapeutic goods in Australia, regulating their registration, manufacture, and importation. Specifically, Section 41GP of the Act provides for the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). This authority allows for the removal of listings for medical devices that no longer meet the necessary certification requirements or have been found to be incorrectly certified. The cancellation of entries affects the entities responsible for the devices, such as manufacturers or sponsors, and pertains to the devices themselves, ensuring that only those meeting the prescribed standards are available for use within Australia. The application of this section is nationwide, applying across the Commonwealth, states, and territories. The scope of the Act does not specify any particular exclusions or exemptions, implying a comprehensive application to all relevant medical devices unless otherwise noted in subordinate legislation or regulations. The delegate of the Secretary, such as Dr. Jane Cook, exercises this power to maintain the integrity and safety of therapeutic goods available to the Australian public.

Key Provisions

The main operative sections of the legislation, specifically section 41GP of the Therapeutic Goods Act 1989, require the publication of the cancellation of entries for certain kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). In this case, the delegate of the Secretary to the Department of Health and Ageing, Dr. Jane Cook, has published the cancellation of entries for the medical device "Patient Lifters" with ARTG numbers 164473 and 188718, effective from 26 February 2013. This cancellation is due to a determination that the certifications related to the inclusion of these devices in the ARTG are incorrect or no longer correct in a material particular, under paragraphs 41FD(d) and 41FN(3)(a)(i) of the Act. The Act imposes obligations on the parties or entities it governs, particularly the sponsor of the medical device, in this case, Active Mobility Systems. The sponsor must ensure that the certifications provided for the inclusion of their medical device in the ARTG are accurate and up-to-date. If these certifications are found to be incorrect or no longer correct in any material particular, the delegate of the Secretary has the authority to cancel the device's entry in the ARTG. This process ensures that only devices that meet the required standards and certifications are available for use in Australia. Breach of the requirements outlined in the Therapeutic Goods Act 1989 can lead to various offences, penalties, or civil/criminal consequences. While the specific maximum penalties for breaches are not detailed in this particular legislation, the Act generally allows for fines and imprisonment for serious offences. The delegate of the Secretary's decision to cancel the entries of the "Patient Lifters" in the ARTG underscores the importance of adhering to the Act's provisions to maintain the safety and efficacy of medical devices available to the public. Failure to comply with the Act's requirements can result in severe consequences, including the removal of devices from the market, which can ultimately impact public health and safety.