The Therapeutic Goods Administration (TGA) is inviting consultation from interested parties on future options for the regulation of personalised and 3D printed medical devices.

The increasing use of 3D printing for medical applications is raising questions globally about the adequacy of the current medical device regulatory frameworks to mitigate risks to patients, and to meet requirements for health care providers and manufacturers.

The TGA is seeking comments on its proposed options to:

• potentially re-define ‘custom-made devices’;
• introduce new definitions within the personalised medical devices vocabulary;
• clarify entities who may be liable as a manufacturer of a supplied device;
• harmonise regulatory approaches with other jurisdictions; and
• include special provisions for certain dental and other low risk devices to reduce unnecessary regulation burden.

The purpose of this consultation is to provide an opportunity for the public to contribute to the development of a regulatory framework for personalised medical devices such as those enabled by 3D printing. Reforms will affect industry, healthcare professionals and patients of these medical devices. Comments will assist the TGA to identify issues and ensure regulation of the devices is appropriate to the level of risk.

Submission Requirements & Due Date

• Submissions are due by close of business Friday 22 December 2017
• Complete the online Consultation Submission Form, upload your submission in either PDF or Word format and click submit.

Further Information

For questions relating to submissions, please contact the Director, Business Improvement & Support Section: devicereforms@tga.gov.au