Therapeutic Goods (Articles that are not Medical Devices) Order No.1 2017

Overview

The Therapeutic Goods (Articles that are not Medical Devices) Order No.1 of 2017 was enacted to address a specific gap in the Therapeutic Goods Act 1989, specifically clarifying which products do not qualify as medical devices. This notifiable instrument was created under the authority of Cheryl McRae, a delegate of the Secretary of the Department of Health, and it came into effect the day after its registration. The primary objective of this order is to explicitly exclude certain riboflavin products used in ophthalmic treatments from the definition of medical devices, thereby ensuring they are not subject to the regulatory requirements applicable to medical devices. These products, which are used with UV-A light to strengthen and stabilise the cornea by altering the crosslinking of collagen, are vital in treating eye disorders that cause structural corneal changes.

Scope and Application

The Therapeutic Goods (Articles that are not Medical Devices) Order No.1 of 2017 specifies certain items that are not to be considered medical devices under the Therapeutic Goods Act 1989. This legislative instrument is applicable to any entity or person involved in the classification, importation, supply, or advertising of therapeutic goods in Australia. The order identifies specific riboflavin products that are used for the treatment of certain eye disorders as not constituting medical devices, thereby excluding them from the stringent regulatory requirements applicable to medical devices. This exclusion is geographical in scope, applying nationally across Australia, and is intended to streamline the regulatory process for these particular therapeutic products. The order is effective from the date it is registered and is made under the authority granted by subsection 41BD(3) of the Therapeutic Goods Act 1989. The scope of the order can potentially be extended or clarified through subordinate instruments, although no such extensions or modifications are mentioned in this specific order.

Key Provisions

The Therapeutic Goods (Articles that are not Medical Devices) Order No.1 of 2017 primarily identifies certain therapeutic goods that are not classified as medical devices under the Therapeutic Goods Act 1989 (section 4). Specifically, it declares that riboflavin products instilled into the eyes, used in the treatment of eye disorders causing structural changes within the cornea, are not to be considered medical devices (section 4(a)). This distinction is significant as it affects how these products are regulated, marketed, and assessed for compliance with therapeutic goods standards. The order imposes obligations on entities that manufacture, supply, or claim therapeutic benefits for these specified riboflavin products. It ensures that these products are appropriately classified and managed under the Therapeutic Goods Act, rather than the more stringent regulations that apply to medical devices. This includes adherence to specific labelling, advertising, and record-keeping requirements that are tailored to therapeutic goods but not to medical devices. Manufacturers and suppliers must ensure that these products are registered appropriately and that they comply with the relevant provisions of the Therapeutic Goods Act. Failure to comply with the provisions of this order can result in significant legal consequences. Under the Therapeutic Goods Act 1989, breaches may lead to administrative penalties. For example, supplying a therapeutic good that does not comply with the Act can result in an infringement notice with a maximum penalty of $22,200 for a corporation and $4,440 for an individual (section 36DA(2)). Additionally, continued non-compliance or more serious breaches may lead to prosecution, which can result in heavier penalties, including fines of up to $5.5 million for corporations and $1.1 million for individuals, as well as potential imprisonment terms. These penalties underscore the importance of adhering to the regulatory framework established by the Therapeutic Goods Act and the specific classifications outlined in the order.