EXPLANATORY STATEMENT
STATUTORY RULES 1986 NO. 342
CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT)
ISSUED BY THE AUTHORITY OF THE MINISTER OF STATE FOR INDUSTRY, TECHNOLOGY AND COMMERCE
The principal purpose of the regulations is to amend the Customs (Prohibited Imports) Regulations to include in the Eighth Schedule to those Regulations the following therapeutic devices:
(i) prosthetic heart valves;
(ii) implantable cardiac pacemakers, implantable defibrillators and implantable cardioverters and accessories thereto;
(iii) intra-ocular lenses;
(iv) intra-uterine contraceptive devices; and
(v) drug infusion systems.
Such a change in the Regulations provides a safeguard to the community in relation to the importation of these devices. Faulty heart valves were responsible for a number of deaths in Australia in 1984 and there has been controversy surrounding the use of particular intra-uterine devices. The inclusion of such devices in the Eighth Schedule to the Regulations prohibits the importation of such devices without the permission of the Secretary of the Department of Health.
Details of the regulations are as follows:
Regulation 1 provides that the Regulations come into operation on 2 February 1987. This will allow the industry sufficient time to adjust to the amended Regulations.
Regulation 2 is a technical drafting provision.
Regulation 3 amends the Eighth Schedule to the Customs (Prohibited Imports) Regulations by inclusion of the following items:
“11AA implantable cardiac pacemakers, defibrillators and cardioverters and accessories for these,
“11B intra-ocular lenses, that is, implantable devices used to replace the natural lens inside the eye,
“11C intra-uterine contraceptive devices, and
“13A prosthetic heart valves.
Regulation 4 effects a technical drafting change to the Customs (Prohibited Imports) Regulations, by omitting “Director-General of Health” (wherever occurring) and substituting “Secretary of the Department of Health”, to reflect the correct title of the permanent head of the Department of Health.