Publication of Cancellation of Entries for Kinds of Medical Devices from the Australian Register of Therapeutic Goods – World Shopping Bay Pty Ltd - 198775

Overview

The Therapeutic Goods Act 1989, enacted to regulate the supply and manufacture of therapeutic goods in Australia, was updated in 2013 with the inclusion of Section 41GP, which allows for the publication of the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). This update was introduced to address gaps in regulatory compliance, ensuring that medical devices available on the market meet required safety and efficacy standards. The relevant policy objective is to protect public health by removing non-compliant medical devices from the market. The Secretary to the Department of Health and Ageing, through a delegate, published the cancellation of an entry for a specific kind of medical device, a transcutaneous peripheral nerve stimulator, manufactured by Hivox Biotek Inc and sponsored by World Shopping Bay Pty Ltd, due to the sponsor's failure to comply with a notice requiring the provision of necessary information about the device. This action was taken to maintain the integrity and safety of the therapeutic goods market in Australia.

Scope and Application

The Therapeutic Goods Act 1989 applies to various entities including sponsors, manufacturers, and importers of therapeutic goods in Australia. This particular section, 41GP, specifically pertains to the public notification of the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). The scope of this section is limited to medical devices and their sponsors, and it impacts those entities by removing their products from the ARTG when certain conditions are not met. The geographic reach of the Act is national, as it applies across all states and territories in Australia. In this instance, the cancellation affects a specific peripheral nerve stimulator manufactured by Hivox Biotek Inc and sponsored by World Shopping Bay Pty Ltd, with the cancellation taking effect from 19 April 2013. The Act does not specify exclusions or thresholds within the text, but it does allow for the extension of its application through subordinate instruments, which might detail further specific conditions or procedures for cancellations.

Key Provisions

Section 41GP of the Therapeutic Goods Act 1989 mandates the publication of details regarding the cancellation of entries for specific kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). In this instance, the cancellation pertains to a particular entry for a medical device, namely a transcutaneous electrical nerve stimulation (TENS) device used for analgesic purposes, with the ARTG number 198775. This entry, sponsored by World Shopping Bay Pty Ltd and manufactured by Hivox Biotek Inc, was officially cancelled on 8 March 2013 and the cancellation took effect on 19 April 2013. The cancellation was executed due to the sponsor's failure to comply with a notice issued by the Secretary under section 41JA of the Act. This notice required the sponsor to provide information about the specified kind of medical device. The Act imposes a requirement on sponsors to ensure compliance with such notices to maintain the integrity of the ARTG and to protect public health and safety. Failure to provide the requested information can lead to the cancellation of the device's entry from the ARTG, as demonstrated in this case. In terms of legal obligations, the Therapeutic Goods Act 1989 necessitates that sponsors of medical devices maintain accurate and up-to-date records and promptly respond to any information requests from the Secretary. The Act aims to regulate the quality, safety, and efficacy of therapeutic goods in Australia, ensuring they meet the necessary standards. Sponsors are required to take all reasonable steps to comply with the provisions of the Act, including providing any requested information without delay. Failure to comply with the Act's requirements can result in significant legal consequences. Under the Act, the cancellation of a device's entry from the ARTG is a serious action, reflecting non-compliance with regulatory standards. In addition to the cancellation of the device's listing, breaches of the Act may also result in civil or criminal penalties. While the specific penalties are not detailed in the notice, they can include fines and, in severe cases, imprisonment, underscoring the importance of adhering to the Act's stipulations.