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: 206812
Sponsor: Hoyland Medical 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 Act 1989 was enacted to ensure the safety, quality, and efficacy of therapeutic goods, including medical devices, available in Australia. This Act, administered by the Therapeutic Goods Administration, was introduced to address the need for stringent regulation and oversight of therapeutic goods to protect public health. The 2014 gazetted notice by the Department of Health, acting under the authority delegated by the Secretary, highlights the enforcement of the Act's provisions through the cancellation of an entry for a specific kind of medical device from the Australian Register of Therapeutic Goods. The notice underscores the importance of compliance with the essential principles and the conditions under which devices are included in the register, as failure to meet these requirements can result in the cancellation of the device's registration. This enforcement action serves as a clear demonstration of the policy objective to maintain high standards and ensure that therapeutic goods on the market are safe and effective for their intended use.
Scope and Application
The Therapeutic Goods Act 1989, under which the Therapeutic Goods Administration (TGA) operates, governs the regulation of therapeutic goods in Australia. Section 41GP of the Act provides the authority for the TGA to cancel entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG) if certain conditions are not met. The specified cancellation applies to the transilluminator, a kind of medical device, manufactured by Hoyland Medical Pty Ltd. This action is taken when the sponsor of the device fails to comply with the essential principles or when advertising material does not align with the intended purpose as certified by the sponsor. The cancellation of the ARTG entry number 206812, effective from 4 February 2014, is a measure enforced by the delegate of the Secretary to the Department of Health, in this instance, Dr. Jane Cook. The Act extends its jurisdiction across the Commonwealth, applying uniformly to all entities involved in the registration, manufacture, and advertising of therapeutic goods within Australia. The scope of the Act encompasses various types of medical devices, ensuring they meet specific safety, quality, and efficacy standards. Exclusions or exemptions from the Act's purview are not detailed in this specific notification but generally follow the provisions outlined within the Act and any subordinate legislation that may further define the regulatory framework.
Key Provisions
The main operative sections of this legislation, specifically section 41GP of the Therapeutic Goods Act 1989, establish the process for the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). This process is initiated when the sponsor of a medical device fails to meet certain conditions, such as failing to provide information to substantiate compliance with the essential principles (section 41FN(3)(a)) or when the advertising material does not align with the intended purposes as certified by the sponsor (section 41FD). In this instance, the cancellation pertains to the ARTG entry of the light, transilluminator with the ARTG number 206812, sponsored by Hoyland Medical Pty Ltd, effective from 4 February 2014.
The obligations imposed by the Act on the parties or entities it governs are multifaceted. Sponsors of medical devices must ensure that they provide sufficient information to substantiate compliance with the essential principles, which are the safety, performance, and quality standards that therapeutic goods must meet. Furthermore, sponsors must ensure that advertising material accurately reflects the intended purpose of the device, as certified by the sponsor. Failure to meet these obligations can result in the cancellation of the device’s entry from the ARTG. The Act also requires sponsors to keep accurate records and provide any requested information to the Therapeutic Goods Administration (TGA) to facilitate compliance checks.
The legislation also outlines potential consequences for breaches of the Act. In this case, the cancellation of the ARTG entry for the light, transilluminator is a direct consequence of the sponsor’s failure to meet the specified conditions. Although the document does not specify criminal offences or penalties, it is clear that failure to comply with the conditions for inclusion in the ARTG can lead to the removal of the device from the register. This can have significant implications for the sponsor, including the inability to legally market or supply the device in Australia. Further, continuous non-compliance or serious breaches may lead to more severe consequences, such as fines or legal action under other sections of the Therapeutic Goods Act.