TGA halted this process after stakeholders expressed a need for further clarification on some of the terms in the proposed policy. Inquiries came from industry representatives, care providers, governmental organizations, and consumers alike.

Here were the top requests of stakeholders:

  • Further clarification on the difference between how a custom-made device versus a patient-centric device is defined
  • The elimination of the proposed limit on the annual number of custom-made devices a manufacturer can supply, which could restrict patients’ access to the medical devices they need
  • Stricter definition of what is considered a “medical device production system,” as the environments within which medical devices are currently being manufactured are rapidly evolving and expanding

TGA agreed that its current proposed regulations are too broad and in need of improvement. The organization also stated that it “recognizes the need for further stakeholder engagement on this subject” and is presently accepting comments and recommendations from the public.


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