New medical devices regulatory system a world leader

The new regulatory system for medical devices in Australia, which came into effect on 4 October 2002, firmly places Australia at the forefront of world's best practice for the regulation of medical devices. Australia is the first country to adopt the international regulatory model developed by the Global Harmonisation Task Force.

With the new system comes the world's first web-based electronic application lodgement system for medical devices. Under the new framework, application must now be made to Include medical devices in the Australian Register of Therapeutic Goods (ARTG), and applications are submitted using the Device Electronic Application System (DEAL). The DEAL system has a web front-end and is accessed through the TGA's Strategic Information Management Environment (SIME). Access to the system is based on a user name and password, which can be obtained from the SIME Help Desk on:

Telephone: 1800 010 624
Email: ebs@tga.gov.au
Website: www.ebs.tga.gov.au

Authorised users can view and monitor only those Device Applications drafted or lodged under that username. Administrators within organisations are responsible for management of their users.

Applications for both registration and listing on the ARTG for Other Therapeutic Goods (such as In-vitro diagnostics, hospital/household/commercial disinfectants, devices containing product of human origin) can also be lodged through DEAL.

For those without computer access, hardcopy ARTG application forms can be obtained by calling the Devices Information Unit on 1800 141 144.

Applications for registration or listing of medical devices on the ARTG received by the TGA prior to 4 October 2002 will be processed under the old system, provided the application included all the relevant data and the correct fees were paid.

Sponsors of registered or listed medical devices that were on the ARTG as at 4 October 2002 have five years to demonstrate their products meet the new regulatory requirements. Once a device has been entered on the ARTG under the new system, all entries for that particular device under the previous system will be cancelled.

Medical devices that were exempt from entry on the ARTG will remain exempt for two years, until 4 October 2004. After 4 October 2004, products that no longer satisfy the definition of exempt goods (such as non-sterile surgical instruments), will have to meet the provisions of the new system and be entered on the ARTG before they can be legally supplied in Australia.

Sponsors of medical devices that have been manufactured in Australia that did not require a Good Manufacturing Practice license from the TGA under the previous regulatory regime will be able to continue to apply for 'listing' on the ARTG until 4 October 2004. Any products listed, under these circumstances, between 4 October 2002 and 4 October 2004 will have until 4 October 2007 to meet the requirements of the new system and be included on the ARTG.

New fees and charges apply to medical devices regulated under the new system. For all medical devices already on the ARTG and not transferred to the new system, Other Therapeutic Goods and those that have a specific exemption for a set time, the fees and annual charges applicable for the 2002/03 financial year will continue to apply.

To accommodate the changing work loads the Medical Devices Listing and Medical Devices Registration and Assessment sections have been reorganised into two new sections as follows:

• Application Entry and Co-ordination Section will receive via DEAL applications for all classes of medical devices and Other Therapeutic Goods and coordinate the application entry and conformity assessment activities.
• Medical Device Assessment Section will undertake conformity assessments and application audits.

Information on the new system

A series of very popular and successful 2 day information sessions were held in Sydney, Melbourne, Adelaide and Perth in early June 2002 outlining the details of the new system. These were followed up in September with sessions in Melbourne and Sydney on the practical aspects of using DEAL and information on the new fees and charges model.

More information sessions providing more detailed information for Australian manufacturers will be held in November 2002.

To further assist with the transition to the new regulatory system, an Information Unit has been established to handle general information enquiries. The contact details are:

Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email: CAB.Medical.Device.Information@tga.gov.au

The Therapeutic Goods Amendment (Medical Devices) Act 2002, Therapeutic Goods (Medical Devices) Regulations 2002, Therapeutic Goods Amendment Regulations 2002, Application Forms, information on Fees & Charges and other information on the new regulatory system for medical devices can be found at http://www.tga.gov.au/devices/devices.htm.