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Personalised medical devices update – New notification form for custom-made and patient-matched medical devices

By August 26th, 2022No Comments

TGA has responded to stakeholder feedback, redeveloping and launching a new database for manufacturers and sponsors to notify the TGA of:

  • the manufacture, supply or import of a kind of custom-made medical device; and/or
  • their intention to access the transition arrangements for a patient-matched medical device that needs to transition to inclusion in the Australian Register of Therapeutic Goods (ARTG).

The new Custom Made Medical Device (CCMD) database replaces two separate databases previously used to notify the TGA of custom-made and patient-matched medical devices transitioning to ARTG inclusion.  The database has features that assist with submitting accurate information about these types of devices, and allows the accuracy of the data to be easily maintained.

Over the coming weeks TGA will be contacting stakeholders in a staged way to draw attention to the new database and provide them with guidance to help them with completing the new form. Please download a copy of the guidance for your information.

For ongoing information and updates, please subscribe to the TGA’s Medical Devices Information and IVDs Information email subscription services.