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Manufacturing therapeutic goods

In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence or a conformity assessment certificate. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence or a conformity assessment certificate unless the manufacturer or goods are exempt from this requirement.

Contact details for enquiries about manufacturing therapeutic goods

If your enquiry is not about manufacturing, see: Contact the TGA

If your enquiry is about manufacturing medical devices: Contact the Medical Devices Branch

  • 1800 020 653 (freecall within Australia)
  • +61 2 6232 8644

Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:

  • TTY or computer with modem users: phone 1800 555 677 then ask for 1800 020 653
  • Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 020 653
Fax +61 2 6232 8426
Postal address Manufacturing Quality Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609