COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
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, Jane Cook, delegate of the Secretary to the Department of Health 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 (the ARTG) under paragraph 41GN(1)(b) of the Act:
ARTG entry of kind of medical device: Light, transilluminator
ARTG number: 207079
Sponsor: Biosoft Pty Ltd
Date effective: 4 February 2014
Reasons: As the sponsor did not provide information to substantiate compliance with the essential principles, the sponsor failed to comply with a condition to which the inclusion of the kind of device in the ARTG was subject under s.41FN (3)(a). As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5).
(Signed by)
Dr Jane Cook
Delegate of the Secretary to the Department of Health
28 January 2014
Overview
The Therapeutic Goods Amendment (2011 Measures) Act 2012 was enacted to enhance the regulation of therapeutic goods in Australia, addressing gaps in the existing regulatory framework and ensuring public safety by more stringent oversight of medical devices. The Act was introduced to address issues of non-compliance by sponsors of medical devices with the essential principles and certification requirements, as evidenced by the cancellation of entries from the Australian Register of Therapeutic Goods (ARTG). The policy objective of this legislation, as part of the broader initiative to refine the Therapeutic Goods Act 1989, is to uphold the safety, quality, and efficacy of therapeutic goods available in Australia, thereby protecting consumers from potentially harmful products. The Therapeutic Goods Amendment (2011 Measures) Act 2012 was enacted by the Australian Parliament, reflecting a commitment to strengthening the oversight and regulation of medical devices within the country.
Scope and Application
The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medical devices, and governs their regulation to ensure they are safe, of high quality, and effective. Specifically, section 41GP of the Act enables the cancellation of entries from the Australian Register of Therapeutic Goods (ARTG) if certain conditions are not met, as illustrated in the gazetted cancellation of the ARTG entry for a light, transilluminator, manufactured by Biosoft Pty Ltd. This legislative provision applies to any sponsor of a medical device who fails to provide evidence of compliance with essential principles or whose advertising materials do not align with the certified intended purposes, as stipulated under sections 41FN(3)(a) and 41FD, respectively. The Act's jurisdiction extends across the Commonwealth of Australia, impacting medical device sponsors nationally. The Act does not specify exclusions, exemptions, or thresholds in this context, though its application can be extended or restricted through subordinate instruments, such as regulations or guidelines issued by the Therapeutic Goods Administration.
Key Provisions
The key operative section of this legislation (s.41GP) involves the cancellation of an entry for a kind of medical device from the Australian Register of Therapeutic Goods (ARTG). Specifically, this notification pertains to the cancellation of the ARTG entry for the device known as a "Light, transilluminator" (ARTG number 207079), sponsored by Biosoft Pty Ltd, effective from 4 February 2014. The cancellation is due to the sponsor's failure to provide sufficient information to substantiate compliance with the essential principles, and the advertising material not aligning with the certified intended purpose of the device.
The Therapeutic Goods Act 1989 imposes several obligations on the parties involved, particularly the sponsor of the medical device. These obligations include ensuring that the device complies with the essential principles outlined in the Act and that all information provided, including advertising materials, accurately reflects the certified intended purpose of the device. The sponsor, in this case Biosoft Pty Ltd, must ensure that all representations about the device are truthful and consistent with the certification process. Failure to meet these obligations can lead to the cancellation of the device’s ARTG entry.
Under the Therapeutic Goods Act 1989, breaches of the conditions set forth for the inclusion of a device in the ARTG can result in various consequences. The cancellation of an ARTG entry, as seen in this instance, is one such consequence. While the Act does not specify criminal offences or penalties directly in this notification, it is important to note that further breaches or more serious violations could lead to enforcement actions, fines, or other penalties as outlined in different sections of the Act. The specific penalties for such breaches can vary, but they may include substantial fines and, in severe cases, criminal charges.
The Therapeutic Goods Act 1989 also provides mechanisms for civil and criminal proceedings in cases of non-compliance. For instance, Section 86 of the Act allows for civil penalties for breaches of the Act, which can include significant financial penalties. Additionally, under Section 90, more serious breaches that are likely to cause death or serious injury can result in criminal charges, with potential penalties including imprisonment. These provisions underscore the importance of compliance with the Act's requirements to avoid severe repercussions.