Commonwealth Consolidated Acts Commonwealth Consolidated ActsAny standards that were in force immediately before the commencement of this Act under Part 2 of the Therapeutic Goods Act 1966 , and any requirements that were in force at that time under section 15 of the Therapeutic Goods Act 1966 , continue in force as if they were standards made under Part 3 - 1 of this Act.
The conformity assessment procedures set out the requirements relating to the application of quality management systems for medical devices, and other requirements imposed on manufacturers.
Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied to medical devices.
(a) that relevant quality management systems have been applied to the device;
(b) the essential principles for the device have been complied with;
(c) other certification requirements of the conformity assessment procedures have been met.
Kinds of medical devices can be included in the Register if they comply with the essential principles, and conformity assessment procedures have been applied to the kinds of devices or requirements, comparable to those procedures, have been applied to the kinds of devices (and certain other requirements are complied with).
Inclusions in the Register are subject to certain automatic conditions and the Secretary may impose further conditions.
Inclusions in the Register may be suspended in certain circumstances, such as when a conformity assessment document is suspended. A kind of medical device that is suspended is taken not to be included in the Register for most purposes.
Inclusions in the Register may also be cancelled in certain circumstances.
(a) medical devices exempted under the regulations;
(b) approval for medical devices to be used for special treatment of individuals or for experimental purposes;
(c) authorisation of health practitioners to supply specified medical devices;
(d) medical devices exempted if substitutes are unavailable or in short supply.
The Secretary may seek information or documents relating to:
• the application of conformity assessment procedures or requirements comparable to those procedures;
• compliance with the essential principles;
• compliance with other requirements;
• distribution of, and other matters relating to, medical devices covered by exemptions under Part 4 - 6A or Part 4 - 7.
This Part contains offences and civil penalty provisions that are aimed at ensuring that:
• the essential principles are complied with (see Division 1);
• the conformity assessment procedures have been applied to kinds of medical devices or requirements, comparable to those procedures, have been applied to kinds of medical devices (see Division 2);
• administrative processes put in place by Parts 4 - 4 to 4 - 9 are followed (see Divisions 3, 3A and 4).
The Secretary can give a person an infringement notice for a contravention of a provision of this Act or the regulations that is an offence of strict liability or for a contravention of a civil penalty provision.
The person can choose to pay an amount as an alternative to having court proceedings brought against the person for the contravention. If the person does not choose to pay the amount, proceedings can be brought against the person in relation to the contravention.
The Secretary can seek injunctions from the Federal Court or Federal Circuit and Family Court of Australia (Division 2) to restrain a person from contravening this Act or the regulations, or to compel compliance with this Act or the regulations.
Interim injunctions are also available.
This Part provides the basis for a uniform system in Australia of access controls for goods containing scheduled substances.
The scheduling of substances allows restrictions to be placed on their supply
to the public, in the interests of public health and safety. This is aimed at
minimising the risks of poisoning from, and the misuse and abuse of, scheduled
substances.