Device registration news

Staff of the Device Registration and Assessment Section, like all those within the device program, are being kept busy contributing to the task of developing processes, procedures and guidance documents for implementation of the new device regulatory system.

Nevertheless, the work output figures for registration of devices continue to meet agreed targets. At the end of the March 2001 quarter the average evaluation time was 56 days, with 43 submissions finalised in the quarter, and 83 submissions in progress.

The great majority of applications received for registration of active device products are assessed by the "abridged" route, where a sponsor may claim equivalence in one or more aspects to a device already registered in that sponsor's name. However, sponsors should note that equivalence may only be claimed to a device that is currently registered, not to devices that are still under evaluation. The predicate device must be registered before any claim of equivalence can be accepted.

TGA announces pilot for applications for registration utilising the GHTF summary technical document

The TGA is commencing a pilot premarket review program for some registered devices and is inviting participation from the medical devices industry. The pilot program is intended to evaluate the utility of a draft guidance document, from Study Group 1 (SG1) of the Global Harmonization Task Force (GHTF) - Demonstrating Conformity Assessment to the Essential Principles of Safety and Performance of Medical Devices (STED).

This pilot study is being undertaken in a number of participating countries represented on the GHTF. It is envisaged that the pilot study will run in Australia until the end of 2001, but this may vary depending on the level of participation by industry. At the conclusion of the study, SG1 will evaluate the findings from the different regions.

The draft STED, developed by SG1, describes an internationally harmonised format and content for premarket submissions. Two key references to the document are other GHTF publications - Essential Principles of Safety and Performance of Medical Device and Role of Standards in the Assessment of Medical Devices.

Copies of the GHTF documents are available from the GHTF website <http://www.ghtf.org>.

The pilot program will be limited to the following categories of registered devices:

• Active Implantable Medical Devices
• Drug Infusion Systems
• Extracorporeal Therapy Systems
• Mechanical Heart Valve Prostheses
• Intra-ocular lenses
• Intra-ocular Fluids (but not those of animal origin)
• Intra-uterine Contraceptive Devices
• Barrier Contraceptive Devices
• Saline Filled Breast Prostheses
• Instrument Grade Disinfectants & Sterilants

Industry is encouraged to take the opportunity to participate in the work of the GHTF.

Therapeutic Device Evaluation Committee (TDEC) 2001/1 meeting report

The 2001/1 meeting of the Therapeutic Device Evaluation Committee (TDEC) was held at the TGA, Canberra, on 6 April 2001.

The major issues discussed during the meeting were

1. The evaluations of two tissue heart valves, an implantable defibrillator, a mammary prosthesis and an anaesthesia infusion pump;
2. A proposal for the use of labelling symbols for medical devices;
3. Problem report investigations regarding:
   • a fire on a home use motorised wheelchair resulting in the patient's death;
   • calcification/opacification of an intra ocular lens; and
   • the failure of an implantable Left Ventricular Assist Device;
4. The new regulatory system for medical devices; and
5. Activities of the Global Harmonization Taskforce (GHTF), including Australia's role as the new GHTF Chair.

The 2001/2 TDEC meeting will be held at the TGA in Canberra on Friday 27 July 2001.

Update on new medical devices legislation

The Therapeutic Goods Amendment (Medical Devices) Bill 2001 was introduced into Parliament on 29 March 2001. The amendment Bill will be debated in the Winter 2001 sitting of Parliament. Pending Parliamentary approval, it is anticipated that the new regulatory system for medical devices will be implemented in late 2001.

The Therapeutic Goods (Medical Devices) Regulations 2001 are being developed. An initial draft of the Regulations (the Essential Principles and Classification Rules) is available. Following consultation with stakeholders, it is planned to finalise the Therapeutic Goods (Medical Devices) Regulations 2001 by early July 2001. Both the Act and the Regulations will come into force on the same day.

There is ongoing consultation to inform stakeholders about the new regulatory system and to develop the new medical device Regulations.