Suspension & cancellation of a medical device entry in the Australian Register of Therapeutic Goods (ARTG)
Fact sheet no. 32
October 2006
1. Suspension of a medical device
Under the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill, 2002 (the Act) and the Therapeutic Goods (Medical Devices) Regulations, 2002 the Therapeutic Goods Administration (TGA) has the power to suspend a medical device, before cancelling it. This power is outlined in Part 4-6 of the Act. A suspension may be undertaken for the following reasons:
- A certificate of conformity (either issued in Australia or by an overseas regulatory agency) is revoked1; (Chapter 4, Part 4-4, Division 3 and 4 of the Act);
- There is a potential risk of death, serious illness or serious injury if the kind of device continues to be included in the Australian Register of Therapeutic Goods (ARTG) Chapter 4, Part 4-6 of the Act;
- It is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the kind of device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the ARTG;
- The Secretary of the Department of Health and Ageing is satisfied that it is likely that there are grounds for cancelling the entry of the kind of device from the ARTG or;
- Fees have not been paid to the TGA for the application.
A device may be suspended for a maximum period of 6 months. The sponsor will be notified that this has occurred. However, this period can be extended for a further 6 months (maximum) if the TGA is satisfied that the manufacturer has demonstrated they are correcting the issue(s) that led to the suspension. If this extension period expires, then the entry on the ARTG is automatically cancelled.
1 A certificate of conformity issued overseas can only be revoked by the overseas regulatory body for the device to be suspended from the ARTG.
2. Cancellation of an entry
The TGA will cancel products from the register under Chapter 4, Part 4-6 of the Act only in those cases where there has been a severe breach of the law or, more often, where there is a safety concern associated with the use of the product. If a sponsor cannot satisfactorily establish the quality, safety or efficacy of their product and a decision to cancel the entries in the ARTG is confirmed, the sponsor will also be required to recover any affected products.
The principles of natural justice are followed by the TGA whenever a proposal to cancel a product in the ARTG is considered. The cancellation proposal will be submitted to a sponsor and they will be allowed a certain period of time to show cause why the cancellation should not occur. The sponsor may also be given the opportunity to submit any data to support their case. A decision will be made once this time has elapsed and any submitted information has been assessed. If it is decided to cancel the registration, listing or inclusion, sponsors normally have an opportunity to lodge an appeal. The sponsor's rights in the cancellation process are explained in the cancellation letter.
Some examples of when a cancellation of a medical device from the ARTG will occur are:
- A suspension period expires, and the issue has not been resolved to the satisfaction of the TGA;
- A conformity assessment certificate applying to that kind of device has been revoked;
- There is an imminent risk of death, serious illness or serious injury if the kind of device continues to be included in the ARTG;
- Devices of that kind are no longer therapeutic goods;
- Devices of that kind are no longer medical devices;
- The sponsor requests in writing the cancellation of the entry of the kind of device from the ARTG;
- A statement made in relation to an application or certification was false or misleading;
- The annual charge payable in respect of the inclusion of the kind of device in the ARTG is not paid within 20 days after it is due;
- A sponsor who is responsible for the compliance of advertising with the Therapeutic Goods Advertising Code, does not comply with the direction or requirement;
- There is a serious breach of the requirements relating to advertising and;
- A sponsor fails to respond to a request for information in accordance with the "reasonable" time provided in the request.
Notice of the cancellation will be published in the Commonwealth Gazette.
Other Therapeutic Goods (medicines and Therapeutic Devices - see Guidance Document 9 Transitional Arrangements for the Introduction of the New Medical Devices Regulatory System <http://www.tga.gov.au/docs/html/devguid9.htm> for an explanation of these terms) continue to be regulated under the previous regulatory scheme, and therefore the current powers of cancellation under Section 30 and those under Section 9B will exist.
3. What happens after a device is cancelled from the ARTG?
In the event a device is cancelled from the ARTG, the TGA may request a sponsor to recover the device (Chapter 4, Part 4-9, of the Act). A delegate of the Secretary of the Department of Health and Ageing has the discretion to decide which devices are to be recovered and this information will be published in the Commonwealth Gazette.
4. Product recall/recovery provisions under the Therapeutic Goods Act 1989
The Act contains separate but similar recall provisions for therapeutic goods regulated under Chapter 3 and therapeutic goods regulated under Chapter 4.
Therapeutic goods regulated under Chapter 3 include medicines, therapeutic devices covered by transitional arrangements and exempt goods. The recovery provisions for these goods are set out in Chapter 3, Part 3, Division 2A of the Act.
Therapeutic goods regulated under Chapter 4 are medical devices. The recovery provisions for medical devices are set out in Chapter 4, Part 4 -9 of the Act.
Chapter 4, Part 4-9, Section 41KA of the Act provides for the public notification and recovery of medical devices.
The Secretary may take action in relation to medical devices where:
- The goods are included in the Register but do not comply with the essential principles, or the conformity assessment procedures have not been applied to medical devices of that kind;
- The goods supplied are exempt devices, or there is an approval under section 41HB of the Act (exemptions for special and experimental uses) relating to devices of that kind, or there is an authority under section 41HC of the Act (exemptions for medical practitioners) relating to devices of that kind, but medical devices of that kind do not comply with the essential principles, or the conformity assessment procedures have not been applied to medical devices of that kind;
- The goods supplied are not included in the Register and are not an exempt device, and there is no approval under section 41HB of the Act relating to medical devices of that kind, and there is no authority under section 41HC of the Act relating to medical devices of that kind;
- The goods have been suspended from the ARTG; or
- The goods have been cancelled from the ARTG;
- Depending on the circumstances, either the person supplying the goods or the person in relation to whom the goods are included in the Register may be required by the Secretary to take action in relation to the goods.
The person on whom the Secretary imposes requirements can be required to do one or more of the following:
- Take specified steps in a specified manner and within the reasonable period specified to recover medical devices that have been distributed;
- Inform the public or a specified class of persons what has happened.
The imposition of requirements to recover medical devices may be limited to those medical devices of the kind to which the specific circumstances apply.
Recall requirements do not apply to a medical device that cannot be recovered because it has been administered to, or applied in the treatment of, a person.
Imposition of requirements under section 41KA of the Act does not affect the Secretary's powers of suspension and cancellation.
When the Secretary takes action under section 41KA of the Act, the Secretary must cause to be published in the Gazette a notice setting out the particulars of the requirements imposed.
Non-compliance with requirements imposed under section 41KA of the Act constitutes an offence punishable on conviction by a maximum penalty of 60 penalty units.
Further information on how to carry out a product recall can be obtained from the Uniform Recall Procedure for Therapeutic Goods <http://www.tga.gov.au/docs/html/urptg.htm>.
5. Review of decisions
The procedures for appeals against decisions made by the TGA administering the Therapeutic Goods Act 1989 are described in Section 60 of the Act. The procedures provide for sponsors to request a review of the initial decision taken by the TGA. A request for such a review should be made in writing within 90 days of the written advice of the TGA decision (directions on how to proceed with a review will be given in the letter containing the initial decision), and should be sent to the Minister for Health and Ageing.
After the decision has been reviewed, the Sponsor will be given a statement of the outcome and, if the decision is confirmed, advice on further options available. The Minister may confirm the initial decision or revoke it and substitute another decision in its place. If the Sponsor does not receive notice of the review of the decision within 60 (calendar) days of the request it is taken that the initial decision is confirmed.
The result of the review is subject to the Administrative Appeals Tribunal Act 1975 and if the Sponsor is dissatisfied with the results of the review they may then make an appeal to the Administrative Appeals Tribunal for a review of the decision.
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 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: http://www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606
© Commonwealth of Australia 2006