Medical Device Sponsors
Before someone can supply a medical device for sale in Australia they are required to make an application to include the device in the ARTG. The sponsor is the person or company responsible for the importation of medical devices into Australia, and/or the supply of medical devices in Australia, and/or the export of medical devices from Australia, as well as making application to the TGA to have their device included in the ARTG.
The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.
Responsibilities of a medical device sponsor
The medical device sponsor must:
- have procedures in place, including a written agreement with the manufacturer, to obtain information from the manufacturer when requested by the TGA
- ensure that
– they have available sufficient information to substantiate compliance with the Essential Principles or have procedures in place to ensure that such information can be provided from the manufacturer to the TGA within 20 working days
– an appropriate conformity assessment procedure has been applied to the medical devices
– the manufacturer has appropriate conformity assessment evidence for the medical device
– the conformity assessment evidence remains valid while the device is supplied in Australia
§ for devices other than Class I not supplied sterile or with a measuring function, submit the conformity assessment evidence to the TGA
- apply to include the medical devices in the ARTG, including certifying that the information provided is complete and correct
- pay the fee for applying to include the medical device in the ARTG, and where applicable pay the fees for an application audit to be conducted
- upon request
– provide documentation relating to the medical device to the TGA
– deliver samples of the medical device to the TGA
– allow a person authorised by the TGA to enter and inspect any premises, including outside Australia, where the devices are manufactured or located
§ notify the TGA of certain incidents and performance issues
§ ensure the information about the device complies with the regulatory requirements
§ pay the annual charges for ongoing inclusion of the medical device in the ARTG
Let CMS assist you in evaluating the Australian medical device regulatory framework as it applies to your device(s).
About CMS:
Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.