Draft guidance on the regulation of custom made medical devices

Dear Stakeholder

Guidance document on the regulation of custom-made medical devices - draft for consultation and comment

In developing the regulatory framework for medical devices implemented in October 2002, provisions were introduced to regulate the manufacture and supply of custom-made medical devices. These provisions came into effect on 4 October 2004.

These provisions impose requirements on this group of manufacturers and suppliers relating to:

• Demonstrating compliance with the Essential Principles of safety and performance
• Documentation of manufacturing processes
• Labeling of the finished medical device
• Record keeping
• Post market reporting
• Notification of manufacturing activities to the TGA

These last of these provisions was not implemented at the time of introduction of the new regulations in October 2004, but the TGA is now proposing to introduce this requirement as the final step in establishment of the Regulations.

The attached draft guidance document has been prepared to provide guidance to manufacturers and suppliers of custom made medical devices in regard to their regulatory obligations, including guidance on the procedures on how to notify the TGA of the range of devices manufactured or supplied by an organisation and/or practitioner.

Yours sincerely

Dr Larry Kelly
Head, Office of Devices, Blood & Tissues

December 2008