TGA News Issue 51 (November 2006) - Medical devices

Important advice regarding listed and registered devices

On 31 May 2006 the TGA wrote to all sponsors of medical devices advising of the need to transition listed and/or registered devices (except tampons, disinfectants invitro diagnostics and devices of human origin) to the new medical devices regulatory system prior to 4 October 2007.

The response to that letter and the training programs offered during April and May 2006 has been great and by mid-July 2006 the number of listed and registered devices to be transitioned dropped from 18,000 to 16,000.

The purpose of this follow-up message is to:

• remind sponsors this transition must be completed by 4 October 2007 to ensure continued lawful supply;
• advise sponsors this process is NOT an automatic transfer. Applications must be submitted to have the manufacturer evidence accepted and to have the application assessed and entered on the Australian Register of Therapeutic Goods (ARTG) as an "included" device; and
• provide the following tips for submitting applications and guidance for further assistance.

Tips and hints for submitting applications

Timeframe for submitting applications

Applications need to be submitted to the TGA via the internet using the Device Electronic Application Lodgement (DEAL) system as soon as possible. If there is an influx of applications late in the transition period, the TGA will not be able to guarantee that the assessment process will be finalised and the devices included on the ARTG by the 4 October 2007 deadline.

Information needed from the manufacturer

Contact the manufacturer of the device to obtain the following essential information:

• the risk classification and the Global Medical Device Nomenclature (GMDN) Code for the device;
• the manufacturer's intended purpose for the device; and
• a copy of the manufacturer's evidence that the device has undergone a similar process of conformity assessment to that required in Australia - this will be in the form of either:
  1. an EC Certificate with any annexes for overseas manufacturers - OR -
  2. a Conformity Assessment Certificate issued by the TGA.
• a copy of the manufacturer's Declaration of Conformity to the new Australian regulatory requirements for each device and/or each GMDN code.

Establish e-business account and access to DEAL

If sponsors have not already done so, establish an E-business account with the TGA to obtain access to DEAL. Application forms to do this are available on the Internet

• E-business client access form <https://www.ebs.tga.gov.au>
• Client details form <http://www.tga.gov.au/docs/html/forms/clientdt.htm>

Once all this essential information has been collected, complete the following steps:

Submit manufacturer's evidence

Submit the manufacturer's evidence using DEAL (this is an acceptance process for the evidence and no application fee is payable).

Note - This step is not required for class 1 devices that are not supplied sterile and/or do not have a measuring function.

Submit device application

Once the TGA has advised that the manufacturer's evidence has been accepted, submit the device application(s) through DEAL. This is an approval process with an application fee.

Note - For devices other than Class III or AIMD, the application (and subsequent inclusion on the ARTG) is for a 'kind of medical device' not individual models of the device. A 'kind of medical device' is a group of devices from the same manufacturer, with the same sponsor, have the same classification and the same GMDN code.

Cancel the old entry for the listed or registered device

Using the DEAL application, instruct the TGA to cancel the product entry(ies) or registration(s), listing(s) on the ARTG which have been transferred as a consequence of the new application.

Ensure that all the product entries under a listing (AUST L) or a registration (AUST R) are transitioned before cancelling the listing or registration.

Note - Cancelling the listing or registration, once all products have transitioned will help to avoid the potential for an ongoing duplication of the annual charge.

Payment of annual charges

Sponsors who are submitting a new included application for a old listing/registration need to contact the TGA Revenue Manager in writing to TGA.Accounts@tga.gov.au to make arrangements for 2006/7 annual charges.

Further assistance

• Guidance documents that explain the regulatory system <http://www.tga.gov.au/devices/devices.htm>
• Information regarding the fees and charges <http://www.tga.gov.au/docs/html/feesach.htm#fees>
• Industry associations who can put you in touch with regulatory affairs consultants <http://www.tga.gov.au/docs/html/regafair.htm>
• Updates are also available by subscribing to the TGA-UPDATE email list <http://www.tga.gov.au/new/tga-update-subscribe.asp>
• Advice is available via the TGA information phone service for devices on 1800 141 144

In vitro devices

• Road map showing an overview of the regulatory pathway to market for an IVD under the forthcoming IVD framework <http://www.tga.gov.au/devices/ivd-overview.htm>
• Information explaining that the proposed 2006 implementation in Australia of the new IVD regulatory framework will be delayed to coincide with the joint regulatory scheme under the Australian New Zealand Therapeutic Products Authority

Single use medical devices

• Update on the regulation of the re-manufacture of single use medical devices (time frame for semi-critical and non-critical devices extended to 1 July 2007) <http://www.tga.gov.au/devices/sudupd0610.htm>
• Fact sheet on Definitions relating to the regulation of the re-manufacture of single use medical devices <http://www.tga.gov.au/devices/sud-definitions.htm>
• Fact sheet on Re-manufacturing single use medical devices (information for manufacturers) <http://www.tga.gov.au/devices/fs-sudman.htm>

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