Australian medical devices guidance documents

Guidance document 5 The declaration of conformity <http://www.tga.gov.au/docs/html/devguid5.htm> has been updated; there is a draft document 17 Systems and procedure packs available for comment; and, a new document 22 The essential principles for medical devices <http://www.tga.gov.au/docs/html/devguid22.htm> has been published.

GHTF news

The Chair of the Global Harmonization Task Force (GHTF) passed formally from the Asia/Pacific Region to Europe on 26-27 January 2004. The Chair rotates three yearly between the worlds leading medical devices regulatory agencies in North America, Asia/Pacific and Europe. The Therapeutic Goods Administration (representing Asia/Pacific) was the inaugural Chair of the newly established GHTF Steering Committee in January 2001. The Chair then moved to Japan for the second 18 months of the Asia/Pacific tenure.

The Japanese delegation met with European Commission officials on 26-27 January 2004 to formally hand over the Chairmanship of the Global Harmonization Task Force on Medical Devices (GHTF). This meeting marks the beginning of Europe's three year term as Chair of the GHTF, which is an international group involving medical device regulators and industry representatives from US, Canada, Japan, Australia and Europe, dedicated to promoting regulatory harmonization at a global level and facilitating international trade.

The meeting formally handed over the Chair, held by Dr Taisuke Hojo, Director, Office of Medical Devices Evaluation, Pharmaceutical and Food Safety Bureau, Japanese Ministry of Health, Labour and Welfare, to Mr Cornelis Brekelmans of the European Commission on behalf of Europe.

Under the overriding theme of "Enhancing Patient Safety", Europe will propose, through the GHTF Steering Committee, action on new items such as "design for patient safety", medical device software and new technologies. Further important priorities remain common data sets, implementation of the GHTF Strategic Direction, clarification of GHTF cooperation with international organisations, revision of the GHTF statutory rules adopted in Ottawa in 2000, and improvement of handling and adoption of GHTF Study Group Documents.

Launched in 1992, the GHTF has developed guidance on regulatory harmonization on fundamental issues, a large part of which are now being successfully implemented world-wide. These include essential principles for safety and performance of medical devices, technical documentation for pre-market submissions, global vigilance and reporting mechanisms, global nomenclature, quality management systems for medical devices, and regulatory auditing practices.

Further information can be found at the GHTF website.

MDEC 2nd meeting

The summary of key resolutions of the second Medical Device Evaluation Committee (MDEC) meeting (November 2003) is available.

• MDEC Meeting 2003/2 summary of key resolutions <http://www.tga.gov.au/docs/html/mdec/mdec20032.htm>

Re-manufacturing single use medical devices

In October 2003, the National Coordinating Committee on Therapeutic Goods (NCCTG), agreed to the implementation of a national regulatory framework for re-manufacturing single use devices on 1 December 2003 with a two-year transition period. Under this framework any facility re-manufacturing SUDs has until December 2005 to comply with the requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.

To assist facilities intending to re-manufacture SUDs, the Therapeutic Goods Administration (TGA) will be holding a two-day seminar on the regulatory framework in March 2004. The preliminary draft program and registration form are attached to the letter sent to stakeholders explaining the seminar.