DEAL application fees for medical devices

The new medical devices regulatory framework and the electronic submission of applications for entry on to the Australian Register of Therapeutic Goods through the Device Electronic Application Lodgement System (DEAL) has been in place now for four months.

The use of DEAL has meant sponsors have had to become accustomed to a new way of conducting business with the TGA, as well as understanding the substantially different regulatory requirements of the new framework. The TGA has seen a number of applications incorrectly submitted through the system. The major mistakes made by sponsors have been:

• applying for a listing rather than inclusion of the goods
• incorrect classification of the device
• applying for inclusion when conformity assessment is required (some class IIIs and Active Implantable Medical Devices
• incorrect application of the GMDN code for device identification.

In recognition of the learning curve associated with the introduction of the new system, the TGA will allow incorrect applications to be withdrawn and the fees originally paid will be applied against a replacement application. This process will not apply when an application has been rejected or withdrawn for other reasons, such as incorrect/expired certification or making a false declaration.

This introductory arrangement will end on 30 June 2003. After that date, incorrect applications will be rejected and sponsors will need to submit a new application, including new application fees.

For further information contact the DEAL Help Desk on 1800 141 144 or email CAB.medical.device.information@tga.gov.au.

Medical devices guidance documents

A series of guidance documents are currently being prepared to provide more information about many aspects of the new medical devices regulatory program in Australia. Some of the documents are now available from the medical devices page of the TGA website <http://www.tga.gov.au/devices/devices.htm>. The documents are listed under the heading Australian Medical Device Guidance Documents <http://www.tga.gov.au/devices/devices.htm>.

The subjects of the current and proposed guidance documents include:

• an overview of the new system <http://www.tga.gov.au/docs/html/devguid1.htm>
• conformity assessment procedures <http://www.tga.gov.au/docs/html/devguid3.htm>
• application audit procedures <http://www.tga.gov.au/docs/html/devguid2.htm>
• clinical evidence <http://www.tga.gov.au/docs/html/devguid4.htm>
• the declaration of conformity <http://www.tga.gov.au/docs/html/devguid5.htm>
• advertising <http://www.tga.gov.au/docs/html/devguid8.htm>
• alternative therapy products <http://www.tga.gov.au/docs/html/devguid7.htm>
• definitions
• post market requirements <http://www.tga.gov.au/docs/html/devguid11.htm>
• medical device and medicine combination products
• disinfectants and sterilants
• suspensions and cancellations
• offences relating to medical devices.

If the information you require does not appear in the published guidance documents, please contact the Medical Devices Information Unit on phone 1800 141 144, email CAB.medical.device.information@tga.gov.au or mail to

The Medical Devices Information Unit
Office of Devices, Blood and Tissues
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Top of page

Reuse of single use devices

Regulating the re-manufacture of medical devices labelled as single use

The re-manufacture or reprocessing of single use medical devices includes activities such as cleaning and sterilising, assembling, packaging or labelling and represents a number of safety issues including the potential for cross-infection, endotoxin reactions, material degradation and device failure.

The Australian Health Ministers' Advisory Council (AHMAC) decided on 18 July 2001 that any reprocessing of single use medical devices (SUDs) for the purposes of reuse is to be regarded as a manufacturing activity and requires regulation by the TGA. The National Coordinating Committee on Therapeutic Goods (NCCTG), an AHMAC subcommittee, agreed that SUDs should not be re-used unless the reprocessing is undertaken in a TGA-licensed premises to the same standard as applied to the original device and the level of regulation applied should be equivalent to that for the original manufacturer. The NCCTG recommended the regulatory framework for the re-manufacture of SUDs should include GMP licensing of facilities, a review of a technical file or design dossier, labelling and packaging, incident reporting and recalls, device tracking and patient consent.

The proposed regulatory approach is intended to ensure that any reprocessing or re-manufacturing of single use medical devices occurs under a quality controlled environment and meets internationally-recognised standards and best practice principles. This is to ensure that the re-manufactured device is equivalent to the original, is sterile (where applicable), will perform as originally intended and the risks associated with its reuse are equivalent to those of the original device.

In September 2002, the TGA distributed a consultation paper Consultation on the Regulation of the Re-Manufacture of Single Use Devices for Reuse to key stakeholder groups, including health professionals, hospitals, health departments, government agencies, industry and consumer groups. The paper sought comment on the proposal for a national regulatory framework for regulating the re-manufacture of medical devices labelled by the original manufacturer as single use, which will align Australia with the regulatory models in the United States and the European Union. The six-week consultation period was subsequently extended to January 2003 to accommodate additional submissions.

The responses provided valuable comments on the proposal, in particular those relating to technical requirements and patient consent. The TGA is now meeting with Australian states and territories to discuss implementation issues and a report on the stakeholder consultation will be published on the TGA website following these discussions.