Medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. A small number of low risk consumer products are excluded from this requirement.
In October 2002 Australia harmonised its regulatory system for medical devices to closely follow the European system for classification and assessment of medical devices.
The system is risk-based and complex and Advantage Medical Products Consulting can lead you through the maze of TGA guidance documentation. Including devices on the ARTG is required before commencing supply and is done via the web-based TGA eBusiness Services Advantage Medical Products Consulting quickly review your documentation, liaise with your overseas manufacturers and manage the process of including your devices on the ARTG allowing you to focus on your core business.
New Zealand Requirements
New regulations – the Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004.
Under these regulations, sponsors supplying medical devices in New Zealand or exporting medical devices are required to complete a notification in the Web Assisted Notification of Devices (WAND) database.
Sponsors and manufacturers have one month from the date of supply to notify the information on to the WAND database.
New medical device legislation will be introduced in New Zealand at some time in the future.
Until this time, some products regulated as medical devices in Europe and Australia will continue to be regulated as medicines in New Zealand.
Advantage Medical Products Consulting can assist you if you have medical devices in this category.
Other Therapeutic Goods
There are some products that fall outside the definitions of medicines or medical devices and are still controlled as “other therapeutic goods”.
In vitro diagnostic goods for home use, many disinfectants, menstrual tampons, and some other products come under this heading.
Advantage Medical Products Consulting assist you with meeting the TGA requirements for these products.