ARTG Listing Process: Get Your Medical Device Approved in Australia

How To Get Listed Under The Artg

The Therapeutic Goods Administration is the organisation that oversees and regulates medical devices in Australia. They are responsible for establishing and setting regulatory guidelines for medical device regulations.

To get the approval of the TGA, medical equipment suppliers should classify the medical device according to risk levels. As per the TGA’s device classification system, a medical device can be classified as to the following:

  • Class I
  • Class Is/Class Im
  • Class IIa
  • Class IIb
  • Class III/Class AIMD

The higher the class, the higher the risk. And if a medical device qualifies for more than one classification, it will be categorised under the higher class.

How to Get a CE Marking

For a medical equipment supplier to be able to market a medical device in Australia, it has to be given a proper classification first as mentioned above. To be classified, the TGA accepts the European CE Marking, which are granted by a Notified Body. This group or organisation has been designated by a state to evaluate or assess the conformity of a product.

To acquire a CE Marking, medical equipment suppliers must do the following:

  1. Determine the medical device classification.
  2. Have a Quality Management System.
  3. Prepare a Design Dossier or a Technical File.
  4. Have a Clinical Evaluation Report.
  5. If medical device suppliers do not have a physical presence in Australia, they must choose an Australian Sponsor to cooperate and work with the TGA.
  6. Let a Notified Body audit the Design Dossier or the Technical File.
  7. Acquire a CE Marking and ISO 13485 Certification from the Notified Body.
  8. Have a Declaration of Conformity file.

Take note that if a medical equipment supplier already has a European CE Marking for a medical device, the CE marking acquisition in Australia will be simpler.

The Next Steps

Once a medical device has obtained the CE Marking, the steps below should be taken.

All Classifications Except Class I, Non-Sterile, Non-Measuring Medical Devices

  1. As long as a Notified Body properly audits the device, the CE Marking should already have the correct classification.
  2. If the medical equipment supplier has no local presence in Australia, it is required to have an Australian Sponsor who acts as an intermediary between the manufacturer and the TGA. The sponsor will then have its name listed on the medical device and on the label.
  3. Have a Design Dossier and a Declaration of Conformity file ready for submission.
  4. The medical device supplier should prepare a Technical File.
  5. The Sponsor should submit the CE Marking certification for review.
  6. The Medical Device Application must be submitted to the eBusiness System. It should include the device classification, intended purpose statement, and GMDN code.
  7. Pay the application fee.
  8. Once the application is received and approved, a listing number from the Australian Register of Therapeutic Goods (ARTG) is granted.
  9. The medical device can now be sold in Australia.

Class I, Non-Sterile, Non-Measuring Medical Devices

  1. As long as a Notified Body properly audited the medical device, the CE Marking should already specify its classification.
  2. If the supplier does not have any tangible presence in the country, an Australian Sponsor must be obtained to have a mediator between the supplier and the TGA. The Sponsor’s name will be listed on the medical device and on the product label.
  3. Have a Design Dossier and a Declaration of Conformity prepared for submission. You may submit this only if the TGA asks for it.
  4. The supplier/manufacturer should prepare a Technical File.
  5. Pass a Medical Device Application to the eBusiness System. It should contain the Intended Purpose Statement, the GMDN code, and the medical device classification.
  6. Pay the required application fee.
  7. Once the application is approved, the device will get a listing number from the TGA.
  8. The device can then be marketed in Australia.

Class III or AIMD Medical Devices

  1. As long as a medical device has undergone proper auditing by a Notified Body, then it is expected that the CE Marking will specify the device’s correct classification.
  2. If the manufacturer or supplier does not have a tangible presence in Australia, then an Australian Sponsor should be employed to serve as a mediator between the supplier and the TGA. The name of the Sponsor will be listed on the medical device label and the device itself.
  3. The supplier should prepare a Design Dossier or a Technical File, as well as a Declaration of Conformity. These documents will be submitted to the TGA.
  4. The Sponsor should pass the CE Marking certificate into the eBusiness System.
  5. The medical device will then go through a Level 2 Application Audit.
  6. A Medical Device Application should be passed into the eBusiness System. Upon submission, the Intended Purpose Statement, Classification, and GMDN Code should be included.
  7. If approved, the medical device will be given a listing number from the ARTG.
  8. The medical device can now be sold in Australia.

What’s Next?

Once a medical device’s application is approved by the Therapeutic Goods of Australia, its listing will remain valid, unless changes are made to the device that would change its listing, there is an invalid CE Marking, or the annual ARTG listing fee is not settled. Should you wish to know more about the ARTG listing process, please do not hesitate to reach out to Vicki Partridge.

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