Publication of Cancellation of Entries for Kinds of Medical Devices from the Australian Register of Therapeutic Goods - Osstem Australia Pty Ltd - 202504

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, establishes the legal framework for regulating therapeutic goods in Australia, including medicines, medical devices, and blood and blood components. The Act aims to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy, and to protect the public from potential harm. This piece of legislation addresses gaps in the regulation of therapeutic goods to safeguard public health and safety. In this instance, the Act is used to manage the registration and quality assurance of medical devices, ensuring that only those that meet the necessary standards are available for use in Australia. On 23 July 2013, Rodolfo Ferrari, as the delegate of the Secretary to the Department of Health and Ageing, published the cancellation of an entry for a medical device from the Australian Register of Therapeutic Goods. The device, a Surgical Procedure Kit, dental, implant/prosthesis, manufactured by Osstem Implant Co Ltd and sponsored by Osstem Australia Pty Ltd, was cancelled under section 41GN(1)(c) of the Act due to the sponsor's failure to comply with a notice given by the Secretary under section 41JA. The cancellation took effect on 30 August 2013, highlighting the enforcement of compliance with the Act's regulatory requirements for therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of therapeutic goods, including medical devices, and encompasses various entities such as sponsors, manufacturers, importers, and suppliers. This Act is of Commonwealth jurisdiction and therefore applies across Australia, regulating the supply and advertising of therapeutic goods to ensure public health and safety. The Act includes provisions for the registration of therapeutic goods in the Australian Register of Therapeutic Goods, and it mandates compliance with specific standards and requirements. Exclusions and exemptions may apply under certain circumstances, such as for research and development purposes, and these are detailed in the Act and related regulations. The application of the Act can be extended or restricted through subordinate instruments, which provide additional detail and enforce the provisions of the primary Act. In this instance, the cancellation of the ARTG entry for the surgical procedure kit, dental, implant/prosthesis, highlights the enforcement mechanisms available under the Act to address non-compliance by sponsors, which in this case involved Osstem Australia Pty Ltd failing to comply with a notice issued by the Secretary.

Key Provisions

The primary operative sections of the Therapeutic Goods Act 1989, as referenced in the Gazette, pertain to the cancellation of entries in the Australian Register of Therapeutic Goods (ARTG) (sections 41GP and 41GN(1)(c)). Section 41GP authorises the delegate of the Secretary to the Department of Health and Ageing to cancel entries in the ARTG, while section 41GN(1)(c) provides the basis for cancellation when the sponsor of a therapeutic good, in this case a medical device, fails to comply with a notice issued under section 41JA. The cancellation of the ARTG entry for the Surgical Procedure Kit, dental, implant/prosthesis with ARTG number 202504 was due to the sponsor, Osstem Australia Pty Ltd, failing to comply with a notice given by the Secretary under section 41JA. The Act imposes several obligations on the parties involved, particularly the sponsor of the medical device. The sponsor is responsible for ensuring compliance with all regulatory requirements and notices issued by the Secretary, including adherence to the provisions under section 41JA. Failure to comply with these obligations can result in the cancellation of the device's entry in the ARTG. Additionally, the manufacturer, Osstem Implant Co Ltd, must also ensure that the device meets all safety and efficacy standards required by Australian regulations, though the primary responsibility for compliance with regulatory notices falls on the sponsor. Breach of the obligations under the Act can lead to significant consequences. The cancellation of the ARTG entry effectively removes the product from the market, prohibiting its sale or distribution in Australia. This not only impacts the sponsor's ability to profit from the device but also potentially affects consumers' access to the product. Under section 41GN(1)(c), the Act does not specify particular criminal or civil penalties for the failure to comply with a notice; however, the consequences of non-compliance are severe, including the mandatory cancellation of the ARTG entry. This action underscores the importance of adhering to regulatory requirements to maintain market authorisation for therapeutic goods in Australia.