What is a medical device?
As per the Therapeutic Goods Regulation, Section 41DB, a medical device is:
- ‘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:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
- investigation, replacement or modification of the anatomy or of a physiological process;
- 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
aa. any instrument, apparatus, appliance, material or other article specified under subsection (2A); or
ab. any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or
- an accessory to such an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).’
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.
If you are an importer or an overseas manufacturer of medical devices and you require Australian medical device registration, let Compliance Management Solutions act as your agent or sponsor.
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