TGA Product Registration – KD&A’s Tips and Tricks

TGA Product Registration - KD&A's Tips and Tricks
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If you wish to sell medical devices in Australia, the Therapeutic Goods Administration (TGA) require you to include the device on the Australian Register for Therapeutic Goods (ARTG) under your company name as a sponsor. This process is called product registration or inclusion. Here are some of our tips and tricks for product registration

Importantly, the first step of product registration is to confirm that your product is in fact a medical device. The medical device definition given below is taken 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.

Once you’re sure you have a medical device, check out the requirements associated with being a sponsor of a medical device in Australia.  You can find these in the first section of the TGA’s Australian Regulatory Guidelines for Medical Devices (ARGMD).

Lastly, there are many key steps you can take to ensure your application to the TGA is successful. These include;

  • Understanding the classification of your medical device/s and what that means for your application to the TGA;
  • Where you can, ensuring you have grouped your devices into one application correctly (this will save time and money!);
  • Ensuring you have supporting evidence and an Australian Declaration of Conformity; and
  • Finding a suitable GMDN code.

If this all looks a bit too hard, contact KD&A for a quote to register your medical device or visit our Product Registration Service page. We have many years of experience working with a broad range of medical devices and the TGA.  We know the process, understand the requirements, and can guide you to achieving product registration.

 

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