Offences/enforcement/illegal supply of medical devices

Fact sheet no. 33

October 2006

1. Offences and penalties relating to medical devices

In addition to existing offences that may be committed in relation to therapeutic goods as outlined in Chapter 3, Part 3-2, sections 20, 21 & 22 of the Therapeutic Goods Act, 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill, 2002 (the Act), there are offences (relating to medical devices) which may be committed. These are outlined in Chapter 4, Part 4-11 of the Act.

These offences include:

• illegal importation, exportation, manufacture or supply of medical devices not included in the register and not subject to an appropriate exemption (section 41MI of the Act) with maximum penalties for individuals of imprisonment for 12 months or $110 000, or both, and $550 000 for corporations;
• non-compliance with the essential principles, unless the Secretary has consented (sections 41MA of the Act) with maximum penalties for individuals of imprisonment for 12 months or $110 000, or both, and $550 000 for corporations;
• non-application of an appropriate conformity assessment procedure (sections 41ME and 41MF of the Act) with maximum penalties for individuals of imprisonment for 12 months or $110 000, or both, and $550 000 for corporations;
• failure to comply with the conditions of entry in the Australian Register of Therapeutic Goods (ARTG) (section 41MN of the Act) with maximum penalties of $26 400 for individuals and $132 000 for corporations;
• failure to comply with the conditions of a conformity assessment certificate (section 41MN of the Act) with maximum penalties of $26 400 for individuals and $132 000 for corporations;
• failure to notify adverse events (section 41MP of the Act) with maximum penalties of $44 000 for individuals and $220 000 for corporations;
• failure to notify adverse events etc where an application is withdrawn or lapses (section 41MQ of the Act) with maximum penalties of $44 000 for individuals and $220 000 for corporations;
• misuse of medical devices exempted for special or experimental uses (section 41MO of the Act) with maximum penalties of $6 600 for individuals and $33 000 for corporations;
• claims about arranging supplies of medical devices not included in the ARTG (section 41MM of the Act) with maximum penalties of $6 600 for individuals and $33 000 for corporations;
• making false declarations at the time of entry in the ARTG (section 41MH of the Act) with maximum penalties for individuals of imprisonment for 12 months or $220 000, or both, and $1 100 000 for corporations and;
• making misrepresentations about medical devices (section 41ML of the Act) with maximum penalties of $6 600 for individuals and $33 000 for corporations.

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2. Exceptions to the offences

For the offences listed above, exceptions apply. Non-compliance with the essential principles does not apply if the device complies with one or more medical device standards, but does not comply with the essential principle(s) to which the medical device standard relates. In addition, there is no penalty for labels being changed to suit a country that a device is being exported to.

Failure to apply conformity assessment procedures does not apply if the quality management system complies with one or more conformity assessment standards and those standards relate to the conformity assessment procedure.

Failure to have the device included in the ARTG does not apply if the device is exempt, or the device is intended for special or experimental uses (41 HB), or is comes under exemptions for medical practitioners.

3. Other penalties

In addition to financial penalties for offences under the Act, other penalties can be applied for a failure to comply with provisions of the Act. These include:

• suspension or cancellation of the medical device from the ARTG (Part 4-6 of the Act);
• suspension or revocation of conformity assessment certification (Part 4-4 Division 3 and Division 4 of the Act); and the
• recall of medical devices supplied, either to batch level or all medical devices (section 41MI(1) of the Act).

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4. Enforcement and illegal supply

The Surveillance Unit of the TGA:

• monitors compliance with the Act,
• investigates alleged breaches of the Act, and
• initiates criminal prosecutions where appropriate.

Information regarding the illegal supply of medical devices should be referred to:

Options available to the TGA include criminal prosecutions under section 5A of the Act - for offences included in the Act and fines detailed in many other parts. Illicit goods that have been seized during these investigations are forfeited to the Commonwealth and destroyed.

Disclaimer

This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.

Further information

The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:

Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email: cab.medical.device.information@tga.gov.au
Website: www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606

© Commonwealth of Australia 2006

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