EXPLANATORY STATEMENT
Statutory Rules 1987 No. 37
Customs (Prohibited Imports) Regulations (Amendment)
Issued by Authority of the Minister of State
for Industry, Technology and Commerce
The Government has undertaken the removal of the import controls on certain medical items following a review of the alternative quality and safety controls applying to such goods. The items removed from the Schedules to the Customs (Prohibited Imports) Regulations are Item 6 of the Third Schedule (clinical thermometers), Item 8A of the Eighth. Schedule (condoms and contraceptive diaphragms) and Item 11 of the Eighth Schedule (goods that purport to produce a therapeutic effect by electric, ultrasonic or magnetic influences or by the presence of radio-active elements).
Technological advances over recent years have resulted in the availability of a wide range of thermometers and electromedical equipment, the quality and safety of which cannot effectively be monitored through Customs import controls. The Department of Health now monitors these goods, as appropriate, through the various provisions of the Government’s Medical Device Program.
In respect of condoms and contraceptive diaphragms, these goods are now subject to mandatory standards under the Therapeutic Goods Act 1966. Further, the Department of Health has implemented a random sampling program to ensure that these standards are complied with.
The Regulations provide as follows:
Regulation 1 omits item 6 (clinical thermometers) from the Third Schedule to the Customs (Prohibited Imports) Regulations.
Regulation 2 omits item 8A (condoms and contraceptive diaphragms) and item 11 (goods that purport to produce a therapeutic effect by electric, ultrasonic or magnetic influences or by the presence of radio-active elements) from the Eighth Schedule to the Customs (Prohibited Imports) Regulations.
Overview
The Customs (Prohibited Imports) Regulations (Amendment) Statutory Rules 1987 No. 37, enacted by the Minister of State for Industry, Technology and Commerce, address the issue of outdated import controls on certain medical items. This amendment was necessitated by the advancement of technology, which has led to a broader range of high-quality and safe medical devices that can no longer be effectively regulated through traditional Customs import controls. The policy objective is to streamline the importation process while maintaining quality and safety standards through alternative regulatory frameworks.
The amendment removes clinical thermometers, condoms and contraceptive diaphragms, and therapeutic goods utilising electric, ultrasonic, magnetic, or radioactive elements from the prohibited import lists, reflecting a shift towards more contemporary and health-focused regulatory measures. These items are now subject to quality and safety monitoring by the Department of Health under the Therapeutic Goods Act 1966 and the Medical Device Program.
Scope and Application
The Customs (Prohibited Imports) Regulations (Amendment) Statutory Rules 1987 No. 37, issued under the authority of the Minister of State for Industry, Technology and Commerce, pertains to the removal of certain import controls on specific medical items. This amendment applies to clinical thermometers, condoms and contraceptive diaphragms, and goods that claim to produce therapeutic effects through electric, ultrasonic, magnetic influences, or radioactive elements. The decision to remove these items from the prohibited imports list follows a review indicating that alternative quality and safety controls are now sufficient. These alternative measures are enforced by the Department of Health under the Medical Device Program for thermometers and electromedical equipment, and through the Therapeutic Goods Act 1989 for condoms and contraceptive diaphragms. Additionally, a random sampling program is in place to ensure compliance with the mandatory standards set for these therapeutic goods. The Regulations specifically omit clinical thermometers from the Third Schedule, and condoms, contraceptive diaphragms, and certain therapeutic goods from the Eighth Schedule of the Customs (Prohibited Imports) Regulations.
Key Provisions
The Customs (Prohibited Imports) Regulations (Amendment) Statutory Rules 1987 No. 37, issued under the authority of the Minister of State for Industry, Technology and Commerce, contain several key provisions that have effectively removed certain medical items from the list of prohibited imports. Regulation 1 removes item 6 (clinical thermometers) from the Third Schedule, while Regulation 2 omits item 8A (condoms and contraceptive diaphragms) and item 11 (goods that purport to produce a therapeutic effect by electric, ultrasonic or magnetic influences or by the presence of radioactive elements) from the Eighth Schedule. These changes reflect a shift in the approach to monitoring the quality and safety of these items.
The primary obligations imposed by these Regulations are the removal of specific items from the lists of prohibited imports, thereby indicating that these items are no longer subject to Customs import controls. Instead, the Department of Health is now responsible for monitoring the quality and safety of these items through the Government’s Medical Device Program and various provisions of the Therapeutic Goods Act 1966. For instance, clinical thermometers, which were previously prohibited, are now subject to health department oversight, ensuring that their quality and safety are maintained without the need for import controls.
Failure to comply with the provisions of these Regulations could result in significant legal consequences. While the Regulations themselves do not explicitly state the penalties for non-compliance, breaches of import controls and the Therapeutic Goods Act 1966 can lead to civil and criminal penalties. Under the Customs Act 1901, the importation of prohibited goods can result in fines of up to $11,100 per contravention for individuals and significantly higher penalties for corporations. Additionally, the Therapeutic Goods Act 1989 imposes civil penalties for non-compliance with therapeutic goods standards, including fines of up to $1,650,000 for serious and repeated breaches. These penalties underscore the importance of adhering to the new regulatory framework established by these Regulations.