Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 - Information about Sponsor

On 4 October 2007, the Therapeutic Goods (Medical Devices) Amendment Regulations 2003 (No.2) came into effect, amending subregulation 10.2 and subclause 13.2 in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.

The amendments mean that from 4 October 2007, the name and address of the sponsor of a medical device must be able to be readily identified by a user of the device. The long lead time from the gazettal of the amendments on 16 October 2003 has given sponsors considerable time to comply with the requirements of the Regulations.

A summary of the effect of the amendments follows:

• The sponsor of a medical device is required to provide with the device its name and address in a way that allows the user of the device to readily identify the sponsor, in accordance with specific locational requirements set out in clause 13.2 in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.
• 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.
• The sponsor's name and address may 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.

From 4 October 2007, subregulation 10.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 reads as follows:

10.2 Information about sponsor

1. The sponsor of a medical device must ensure that the sponsor's name and address are:
   1. provided with the device in such a way that a user of the device can readily identify the sponsor; and
   2. located in accordance with clause 13.2 in Schedule 1.
   Penalty: 10 penalty units.
2. If the sponsor of a medical device arranges for a label to be attached or affixed to the device for the purpose of complying with subregulation (1) or for any other purpose (for example, to comply with a labelling requirement under the law of a State or Territory), the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer.
   Penalty: 10 penalty units.

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