Therapeutic Goods Order No. 28 - Standard for Contraceptive Devices - Diaphragms (10/04/1986)

Overview

The Therapeutic Goods Act 1966 was enacted to regulate the supply and quality of therapeutic goods, including medicines, medical devices, and other health-related products available in Australia. This Act was introduced to address the need for a robust regulatory framework to ensure that therapeutic goods are safe, of high quality, and effective. The Therapeutic Goods Administration (TGA), operating under the auspices of the Australian Government Department of Health, was established to administer and enforce the provisions of the Act. The policy objective behind the Act is to protect public health by controlling the importation, supply, and advertising of therapeutic goods, ensuring that they meet acceptable standards of quality, safety, and efficacy. The Therapeutic Goods Order No. 28, specifically addressing the standard for contraceptive devices – diaphragms, was issued by the Minister of State for Health, Neal Blewett, under the authority granted by the Therapeutic Goods Act 1966. This legislative instrument specifies that the Australian Standard 1808-1984 for Contraceptive Devices – Diaphragms, published by the Standards Association of Australia, is to be adhered to for these products. This ensures that diaphragms available in Australia meet the necessary safety and performance criteria, thereby safeguarding consumer health.

Scope and Application

The Therapeutic Goods Order No. 28, promulgated under the Therapeutic Goods Act 1966, mandates the application of the Australian Standard 1808-1984 titled "Contraceptive Devices – Diaphragms" published by the Standards Association of Australia, for all diaphragms classified as therapeutic goods within the Commonwealth of Australia. This legislative instrument applies to entities and individuals involved in the manufacture, import, supply, or advertisement of contraceptive diaphragms, ensuring they adhere to the specified standard. The geographical reach of this Act is national, governing practices across all states and territories of Australia. Notably, this Order does not specify any exclusions or exemptions but is subject to the overarching provisions of the Therapeutic Goods Act 1966, which may provide for exceptions under certain conditions. The application of this Order is further extended or refined through subordinate instruments as necessary to maintain regulatory efficacy and compliance.

Key Provisions

The Therapeutic Goods Order No. 28 specifies that the standard for contraceptive devices – diaphragms must comply with the Australian Standard 1808-1984, published by the Standards Association of Australia (section 1). This standard sets out the specific requirements and specifications that must be met for diaphragms to be considered safe and effective for contraceptive purposes within Australia. Manufacturers, importers, and suppliers of diaphragms are required to ensure that their products adhere to this standard to be legally marketed and sold within the country. The Act imposes obligations on parties involved in the manufacture, import, and supply of diaphragms, including ensuring that these products meet the specified standard (section 2). This includes having appropriate quality control systems in place, maintaining accurate records, and providing documentation that demonstrates compliance with the Australian Standard 1808-1984. These obligations are designed to protect public health by ensuring that only safe and effective contraceptive devices are available to consumers. Failure to comply with the standards set out in the Therapeutic Goods Order No. 28 can result in significant penalties and legal consequences (section 3). Offences under the Therapeutic Goods Act 1966 include the manufacture, supply, or import of therapeutic goods that do not comply with the prescribed standards. Individuals and companies found guilty of such offences may face criminal charges, substantial fines, and potential imprisonment. The maximum penalties can vary depending on the severity of the breach and the intent behind it, but they serve as a deterrent against non-compliance and help maintain high standards in the therapeutic goods market.