Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (MEDICAL DEVICES) AMENDMENT REGULATIONS 2003 (NO. 2) 2003 NO. 259

EXPLANATORY STATEMENT

STATUTORY RULES 2003 No. 259

Issued by the authority of the Parliamentary Secretary to the Minister for Health and Ageing

Therapeutic Goods Act 1989

Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No. 2)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

The purpose of the Regulations is to provide a better means of identifying the sponsor responsible for supplying medical devices. The present provisions of subregulation 10.2(1) of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) do not always ensure identification of the sponsor in an appropriate and consistent fashion.

Section 3 of the Act defines 'sponsor', in relation to therapeutic goods, as a person who exports, imports, or arranges the export or import of the goods to or from Australia, or who manufactures, or arranges for the manufacture of the goods in Australia but does not include a person who does these things on behalf of another person who is a resident of, or is carrying on business in, Australia.

The Regulations ensure that the name and address of the sponsor of a medical device can be readily identified by a user of the device, and make some minor drafting and clarification amendments.

It is necessary for the name and address of the sponsor of a medical device in Australia to accompany the device to enable consumers and users of medical devices to identify the entity legally responsible for supply of the product and product information. Provision of the sponsor's name and address would facilitate consumer and user inquiry and the reporting of adverse outcomes by consumers and users to the sponsor (and in turn to the TGA and the manufacturer). In the event of recall or surveillance action, consumers, users and the regulator must be able to identify the entity legally responsible for the product at the point of supply.

The Regulations also make it clear that the sponsor details may be placed on the outer packaging used for devices where the individual packaging of the devices is impractical for supply and replace the phrase 'trade name' with 'trading name' (of the manufacturer) in the relevant positions to avoid any possible misinterpretation.

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

Details of the Regulations are set out in the Attachment.

Regulations 1 to 3 and Schedule 1 commence on gazettal. Schedule 2 commences on 4 October 2007. This is the date from which requirements for quality, safety and performance of medical devices (set out in Chapter 4 of the Act, inserted in 2002) will apply to medical devices that were already registered or listed goods on the date of commencement of the Therapeutic Goods Amendment (Medical Devices) Act 2002. Commencement on this date allows sufficient time for the clearance of existing stocks before the new requirements specified in Schedule 2 take effect.

ATTACHMENT

Details of the Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No. 2)

Regulation 1 states that the title of the Regulations will be the Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No. 2).

Regulation 2 provides that Regulations 1 to 3 and Schedule 1 will commence on gazettal and Schedule 2 will commence on 4 October 2007.

Regulation 3 provides that Schedules 1 and 2 amend the Therapeutic Goods (Medical Devices) Regulations 2002.

SCHEDULE 1 - Amendments commencing on gazettal

Item 1 amends paragraph 13.2(2)(b) of Schedule 1 by inserting wording to ensure that information required to be provided with a medical device can be placed on the outer packaging for devices packaged together where individual packaging of the devices for supply is not practicable. This amendment clarifies the intended operation of the provision that might otherwise be regarded as placing an unwarranted impost on industry.

Items 2 and 3 amend item 1 of the tables in clauses 13.3 and 13.4 to make it clear that information required to be provided relates to the trading name of the manufacturer.

SCHEDULE 2 - Amendments commencing on 4 October 2007

Item 1 substitutes 'Information about sponsor' as the heading to Regulation 10.2.

Item 2 substitutes a new subregulation 10.2(1) requiring the sponsor of a medical device to provide with the device its name and address in a way that allows a user of the device to readily identify the sponsor and in accordance with specific locational requirements set out in clause 13.2 in Schedule 1. As this amendment will not come into effect until 4 October 2007, this will allow a very considerable period for manufacturers' stocks of labels, and products in the supply chain, to clear before the new requirement takes effect.

Item 3 amends subclause 13.2(3) of Schedule 1 to allow the sponsor's name and address to be included in a leaflet supplied with the device if it is not practical for those details to be provided on the device or on the device's packaging.


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