2007 transition project

The medical devices legislation introduced in October 2002 allowed a five-year transition period for previously supplied devices to comply with the new legislative requirements. This means that on 4 October 2007, medical devices that do not comply will be automatically cancelled from the Australian Register of Therapeutic Goods and cannot be lawfully supplied in Australia until such time as they do comply.

The Therapeutic Goods Administration has been monitoring the transition of these devices over the past three years and, although the transition has been occurring at a steady rate, approximately 18,500 devices still need to transition before the 4 October 2007 deadline. This poses significant challenges for both the industry and the TGA in terms of processing times and resources to lodge and process applications to ensure the continued supply of vital medical devices after October 2007.

Disruption to the supply of medical devices due to non compliance or failure to transition devices within the five-year timeframe could have a significant impact on consumer access to vital medical devices, the supply of medical devices to health care facilities, reimbursement of medical devices and the economic viability of Australian medical device companies.

To this end, the TGA is working with the medical device industry associations, the Medical Industry Association of Australia (MIAA), the Australian Dental Industry Association (ADIA) and AusBiotech, to develop and implement strategies to assist industry to complete the transition of medical devices. This project is referred to as the 2007 Transition Project.

Australian sponsors

As part of the strategy the TGA and the medical devices industry associations are providing a series of education and training programs on the medical devices regulatory requirements and workshops on the IT system for lodging applications. Australian sponsors are urged to take advantage of these training programs and book early.

Information and registration forms for the TGA education seminars and workshops are available on the TGA Internet site.

The TGA is also continuing to produce guidance documents and fact sheets to assist sponsors. Three draft fact sheets, titled Medical Devices Packaged Together; Transition of Listed and Registered Devices to Included Medical Devices on the Australian Register of Therapeutic Goods (ARTG); and, Manufacturers' Evidence - EC Certificates, are available on the TGA Internet site for comment and feedback by 28 April 2006.

Manufacturers

Manufacturers who need to undergo conformity assessment are advised that, due to the lead time for audits and the expected volume of applications, it is in their interest to be prepared and submit applications no later than August 2006 to avoid the possibility that the process will not be complete by October 2007. Manufacturers must have their documentation prepared and ready to undergo assessment before submitting applications.

IVD regulatory framework

The TGA and industry reached agreement on the IVD cost model in November 2005. Drafting instructions for the new regulations have been issued. Once the draft regulations are available the TGA proposes that industry will be given six weeks to comment. The proposed implementation date of 1 July 2006 is contingent upon successful completion of all Parliamentary processes needed to revise the regulations.

The IVD regulatory framework will be implemented in two stages, commencing with the regulatory framework for commercial IVDs, proposed for 2006, followed by the regulatory framework for in-house IVDs at a date to be determined. Class 4 commercial IVDs will have two years to meet the new requirements, while the lower risk Class 1-3 commercial IVDs will have four years to meet the new requirements.

The TGA is planning a round of industry seminars for early May 2006, to be held in the major capital cities, to educate stakeholders about the new requirements. Dates and venues for these seminars will be advertised on the TGA Internet site. The TGA is also working with industry to develop guidance documents on the new regulatory system.

Remanufacture of single use devices

In October 2005 the National Coordinating Committee on Therapeutic Goods (NCCTG):

• agreed to extend the transition period for the implementation of the regulatory framework for the re-manufacture of single use medical devices to:
  • 1 March 2006 for health care facilities to cease re-manufacturing critical devices (devices that come in contact with sterile sites);
  • 1 December 2006 to cease re-manufacturing semi-critical devices (devices that come in contact with mucous membrane and broken skin) and non-critical devices (devices that either do not come in contact with the human body or only contact intact skin);
  • 1 March 2006 for manufacturers to submit their applications to the TGA to re-manufacture for critical devices and 1 December 2006 for semi- and non-critical devices; and
• requested the TGA to establish a jurisdictional workgroup to further clarify the scope of devices captured under this regulatory framework and to provide additional training tools to assist the States and Territories implement policies consistent with the national regulatory requirements.

The TGA is in the process of finalising arrangements to convene the first meeting by early April 2006.