Adverse events reporting

There are now two forms for reporting adverse events associated with medical devices. One form is for use by medical device users, such as nurses, doctors, patients or relatives. The other form is for use by medical device manufacturers and sponsors for mandatory reporting of adverse events associated with a medical device.

• Medical device adverse event reporting - Reporting form for use by medical device users <http://www.tga.gov.au/docs/html/forms/iris_udir.htm>
• Medical device adverse event reporting - Reporting form for use by medical device manufacturers and sponsors <http://www.tga.gov.au/docs/html/forms/iris_mdir.htm>

Dental products regulation

Following introduction of the new Australian medical devices legislation in October 2002, very few products that fit the definition of a medical device will be exempt or excluded from the regulatory requirements. The new legislation provides for a two year transition period for devices that were previously exempt or excluded from the regulatory requirements. For dental products this means that products such as non-powered dental instruments and dental impression materials will no longer be exempt from ARTG entry after 4 October 2004.

See: New regulatory requirements for dental products <http://www.tga.gov.au/docs/html/dentalreg.htm>

In vitro diagnostic devices

The public consultation period for the discussion paper outlining the proposal for a new regulatory framework for IVDs ended in June 2003.

Responses to the proposal and subsequent discussions by the NCCTG IVD Working Group have revealed agreement to key elements of the proposed regulatory framework, including regulation of commercially produced IVDs, home use IVDs, and non-therapeutic IVDs.

The TGA has undertaken a Business Impact Analysis of the proposed new regulatory framework on the Australian market.

• See: New regulatory framework for in vitro diagnostic devices <http://www.tga.gov.au/devices/ivdregfw-bg.htm>

MDEC 2003/1

The first meeting of the Medical Device Evaluation Committee (MDEC) was held on 21-22 August 2003.

• MDEC Meeting 2003/1 Report & Summary of key resolutions <http://www.tga.gov.au/docs/html/mdec/mdec20031.htm>

Reuse of single use devices

On 21 July 2003, the TGA released a statement on regulations for sterilisation of single use devices <http://www.tga.gov.au/media/2003/030721devsud.htm>. Single-use devices (SUDs) are those devices that are intended by the manufacturer to be used once and then discarded.

A number of States and Territories have facilities that undertake sterilisation of SUDs. The TGA's reach does not extend to public hospitals in the States and Territories where most reprocessing of SUDs occurs.

The TGA has taken its concerns up directly with States and Territories and agreement has been reached on the implementation of a national regulatory framework for any re-manufacture of SUDs.