Reprocessing and remanufacturing of medical devices

Overview

The TGA is developing guidance documents on the therapeutic goods regulatory requirements for reprocessing and remanufacturing of medical devices.  This has been developed in response to queries from two key stakeholder groups:

• manufacturers and sponsors of reusable and remanufactured medical devices on compliance with regulatory requirements
• procurement teams, healthcare facilities and healthcare professionals involved in acquiring and using reprocessed and remanufactured medical devices

Please note these draft guidance document reflect the application of existing regulatory requirements to reprocessing and remanufacturing activities, and not any change to existing regulatory obligations. If you have suggestions for change to the existing regulatory framework we would welcome these, but note that they would feed into future policy development and are unlikely to be reflected in these guidance documents.  

Copies of the drafts are below under 'Related'.

Why your views matter

We are seeking feedback from the potential users of this guidance to ensure it is fit for purpose. If you need more time to provide feedback please let us know. 

As an alternative to providing written comments in this form, please feel free to download the drafts below and email them with annotations and/or tracked changes to rachel.croome@health.gov.au