Customs (Prohibited Imports) Regulations (Amendment)

Overview

The Customs (Prohibited Imports) Regulations (Amendment) 1986, issued under the authority of the Minister of State for Industry, Technology and Commerce, was enacted to address safety and quality concerns surrounding the importation of specific therapeutic devices into Australia. This amendment to the Customs (Prohibited Imports) Regulations aims to safeguard the community by prohibiting the importation of certain medical devices without the permission of the Secretary of the Department of Health. The inclusion of these devices in the Eighth Schedule to the Regulations arose due to significant incidents, such as deaths caused by faulty prosthetic heart valves in 1984, and controversies surrounding the use of certain intra-uterine contraceptive devices. By making these devices subject to strict import controls, the amendment seeks to enhance public health and safety by ensuring that only approved and safe medical devices are available for use within Australia.

Scope and Application

The Customs (Prohibited Imports) Regulations (Amendment) Statutory Rules 1986 No. 342, issued under the authority of the Minister of State for Industry, Technology and Commerce, aim to enhance public safety by amending the Customs (Prohibited Imports) Regulations to prohibit the importation of certain therapeutic devices without the explicit permission of the Secretary of the Department of Health. This amendment applies to the importation of prosthetic heart valves, implantable cardiac pacemakers, defibrillators, cardioverters, and their accessories, intra-ocular lenses, intra-uterine contraceptive devices, and drug infusion systems. The legislative change is a response to historical safety concerns, including fatalities caused by faulty heart valves in 1984 and controversies surrounding specific intra-uterine devices. The regulations extend their jurisdictional reach to the Commonwealth level, ensuring a uniform approach across Australia in the regulation of these critical medical devices. The Regulations come into effect on 2 February 1987, providing the relevant industries time to adapt to the new requirements. The amendment does not specify exclusions or exemptions, effectively prohibiting the importation of the listed devices without the necessary approval.

Key Provisions

The main operative sections of the Customs (Prohibited Imports) Regulations (Amendment) are contained in Regulation 3, which amends the Eighth Schedule to the Customs (Prohibited Imports) Regulations. Regulation 3 introduces new entries (11AA, 11B, 11C, and 13A) to the Eighth Schedule, listing specific therapeutic devices such as implantable cardiac pacemakers, defibrillators, cardioverters, intra-ocular lenses, intra-uterine contraceptive devices, and prosthetic heart valves. This amendment effectively prohibits the importation of these devices without the permission of the Secretary of the Department of Health. Regulation 4 makes a technical amendment by replacing "Director-General of Health" with "Secretary of the Department of Health" throughout the Regulations to reflect the correct title of the Department's head. The Regulations impose obligations on importers, manufacturers, and other relevant parties to ensure that the listed therapeutic devices are not imported without the necessary approval from the Secretary of the Department of Health. This includes providing all required documentation and obtaining prior authorisation where necessary. The Regulations also impose a duty on the Department of Health to assess applications for importation of these devices and to make determinations based on safety and efficacy standards. Additionally, customs officials are required to enforce the Regulations by preventing the importation of the listed devices unless approved. Breaching the Customs (Prohibited Imports) Regulations by importing the specified therapeutic devices without the necessary permission can result in both civil and criminal penalties. Civil penalties may include fines, and in severe cases, criminal penalties may apply, which could involve imprisonment. The exact penalties are not specified in the provided text, but they would typically be outlined in the principal Customs Act or other relevant legislation. Importers and other entities found to be in breach of these Regulations may also face additional administrative actions, such as seizure of the prohibited goods and potential bans on future importation activities.