How to make an application through TGA eBusiness services

Frequently asked questions

23 October 2006

1. Where can I find information on the elements of the medical devices legislation?

Various elements of the medical devices legislation are described in a number of guidance documents which can be downloaded from the Medical Devices area of this website.

In particular, the Australian Regulatory Guidelines for Medical Devices (ARGMD) summarises the legislation and includes a definition of a medical device. ARGMD explains the role and obligations of both the sponsor and the manufacturer of medical devices to be supplied in Australia.

Depending on the location of the manufacturer, the type of device, and the risk classification of the device, other Guidance Documents may also need to be reviewed prior to submitting an application for entry on to the Australian Register of Therapeutic Goods (ARTG).

2. As a sponsor of a medical device, do I need to include the device on the ARTG?

All medical devices must be included on the ARTG prior to being offered for supply in Australia. The Register is a database of all therapeutic goods approved for supply in Australia. It can be viewed at TGA eBusiness Services.

Applications for inclusion onto the ARTG are submitted across the web through the Device Electronic Application Lodgement system, more generally referred to as DEAL. Access to most areas of this e-business site is restricted by password.

3. How do I establish an e-business account with the TGA?

New users to the DEAL system will first need to establish an e-business account with the TGA. This is done on TGA eBusiness Services - the eBusiness Services site for the TGA. Click on the eBS Access Forms section of the page and download forms:

  • Client Details Form - only to be completed if, as a sponsor you do not already have a CLIENT identification number. For first time sponsors, the form needs to be completed for both the sponsor and the overseas manufacturer.
  • E Business Access Form - needs to be completed to establish an e-business account with the TGA and obtain an account name and password.

Complete these forms and fax them to the TGA on 02 6232 8581. An account name and password will be sent to the email address specified on the form within a couple of days.

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4. How do I complete a DEAL application?

Step 1 - Obtaining certificates

Obtain, from the manufacturer, a copy of the Declaration of Conformity and the Conformity Assessment Certificate (including any schedules that may be attached).

It is strongly recommended that Australian sponsors obtain a copy of the Manufacturer's Declaration Conformity before submitting application to include a medical device on the ARTG. When submitting an application, the sponsor also declares that he or she can, if requested by the TGA, supply within 20 days, evidence of compliance and the Declaration of Conformity. Further information about the Declaration of Conformity can be found in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Step 2 - Logging on

An application to include a medical device on to the ARTG is submitted via the TGA eBusiness Services website. Click on eBS Access Forms on the home page, download, complete and submit the E-Business form to initiate a request for an account name and password. Both account names and passwords are case sensitive.

Step 3 - User instructions

Once logged on, the user will be taken to the DEAL front page, which will provide a number of options. Download and print a copy of the user instructions for DEAL by clicking on the User Documentation button on the right hand side of the screen. This document will give valuable information and assist you to navigate through the various options available in DEAL.

Step 4 - Establishing manufacturer's conformity assessment evidence

Evidence of the manufacturer's Conformity Assessment Certification needs to be established and registered with the TGA for all medical devices except Class I non-measuring and non-sterile medical devices.

Sponsors should already have a copy of the Conformity Assessment Certificate obtained from the manufacturer in Step 1 of this process. The certificate needs to be an Certificate issued by a Notified Body, under the Medical Device Directive 93/42/EEC or the Active Implantable Medical Device Directive 90/384/EEC.

To register the manufacturers Conformity Assessment Certificate, select Register a manufacturer's Evidence on the DEAL front page and follow the prompts.

The certificate, which may or may not have an attached schedule, must indicate the scope of products covered by the certification and should have an expiry date. If there is no indication of an expiry date, DEAL will automatically set the expiry as five years from the issue date of the certificate. Further information about what is acceptable evidence is available in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Lodgement and acceptance of this evidence generally takes 5 - 10 days and no fees are payable for this process. However sponsor of the medical devices are responsible for maintaining current and valid evidence while the medical device remains on the ARTG. Further information and instructions for providing updated evidence can be found in the DEAL User Documentation.

Step 5 - Applying to Include a Medical Device on to the ARTG

With the exception of class I non-measuring or non-sterile devices, this step can only be completed once the Conformity Assessment Certificate for the manufacturer has been accepted by the TGA in Step 3.

To include a medical device on the ARTG, select Create a Medical Device Application on the DEAL home page. All the information needed to complete this step should be available from a manufacturer's Declaration of Conformity for the medical device. This document, produced by the manufacturer, declares that the device complies with the medical devices legislation in Australia and that they have the necessary documentary evidence to demonstrate compliance if requested by the TGA.

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5. How do I classify a medical device?

The rules for classifying medical devices into class I, class IIa, class IIb, class III or AIMD can be found in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. A link to these Regulations can be found from the Medical Devices page of the TGA website, or directly from the Attorney General's website at ComLaw.

Classification of a medical device using the classification rules is the responsibility of the manufacturer. The TGA recommends sponsors obtain the classification of the device from the manufacturer and not attempt this process as errors in classifying a medical device is likely to delay the processing of the application.

Also see: Australian Regulatory Guidelines for Medical Devices (ARGMD)

6. What is an application audit?

Applications to include Class III medical devices and Active Implantable Medical Devices (AIMDs) on the ARTG undergo a process called an application audit. Applications to include other Classes of medical devices on the ARTG may also be randomly selected for an application audit. These audits are carried out once the TGA receives the application and prior to inclusion on the ARTG. If an application has been identified for an audit, the sponsor will need to provide further documentation to support the application. Information about an application audit, the documentation required and the medical devices selected for an audit can be found in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

7. Where can I find information about application fees?

Full details of fees payable for applications, and assessment fees for compulsory Application Audits can be found in the Summary of fees & charges.

8. What are the processing times for an application?

The processing times for medical device applications vary depending on the number of applications being processed at any one time, the risk classification of the device and whether the application is to undergo an audit. As an indication, processing an application that does not require an application audit, can vary from 3 - 8 weeks. If an application is selected for audit, a sponsor will be given 20 days to provide the required documentation. Review time for this documentation can also vary up to 8 weeks, and is highly dependent on completeness and accuracy of the data provided.

9. Where can I obtain further information?

Sponsors of medical devices can obtain further assistance by contacting the TGA Help Line on 1800 141 144. However, sponsors are urged to read both the DEAL User Documentation and the Guidance Documents before calling the help line. This will help identify the information needed and assist in providing an effective phone service.

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