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What can we do for You?

Many current sponsors and potential sponsors become very confused in what is required to be on the Australian Register of Therapeutic Goods (ARTG) and how do they go about starting.

Firstly you need to understand What is a Medical Device??

From the Therapeutic Goods Act 1989...

41BD What is a medical device

  1. A medical device is:
    1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
      1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
      2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
      3. investigation, replacement or modification of the anatomy or of a physiological process;
      4. control of conception;
      and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
    2. an accessory to such an instrument, apparatus, appliance, material or other article.

Please note it is the manufacturer of the device that determines if the device is a medical device  and also the class of the device.

So how can we help?

  • We can assist you to become a sponsor by sending you the correct forms to use.
  • We can work with you and the TGA by you appointing us as your external agent to work with the TGA on your behalf.
  • We will give you a complete initial assessment of the TGA requirements prior to initiating any work for you at no charge.
  • We will give you feedback and answer questions to ensure that you fully understand the TGA requirements and you financial commitments.
  • We will take on board all your data and work on the files to ensure that all data submitted is in line with TGA and New Zealand requirements.
  • We will prepare and submit all documentations and applications required by the TGA on your behalf as your ongoing agent.
  • Work with you on all audits and documentation required by the regulatory authority.
  • We can assist with Class 1, Class 1  s, Class 1M, Class IIa, Class IIb, Class III and IVD applications as well as conformity assessments
  • We can prepare current Safety Data Sheets (SDS) that are acceptable in Australia and New Zealand.
  • We can also assist with the requirements for Medsafe in New Zealand.
  • We will reduce your stress levels of understanding the regulatory requirements and act as your professional advisors.