Various regulatory requirements and processes apply to the manufacture of medical devices, including in vitro diagnostic (IVD) devices.
Manufacturing for the Australian market
Medical devices imported into, supplied in or exported from Australia must be included in the Australian Register of Therapeutic Goods (ARTG).
This needs to be done by the device's Australian sponsor.
All medical devices included in the ARTG must comply with the Essential Principles and their manufacturers must apply Conformity Assessment procedures (or requirements comparable to Conformity Assessment procedures) that are appropriate to the kind of device.
The usual ways to demonstrate this include:
- Conformity Assessment certification issued by the TGA
- Conformity Assessment certification issued by an Australian Conformity Assessment body
- Conformity Assessment documentation issued by a comparable overseas regulator.
For information about in vitro diagnostic (IVD) medical devices, see our guidance on what a manufacturer needs to know about Conformity Assessment and declarations of conformity for IVDs.
For details of the certification or documents required for different classes of medical devices, see Table 2 in our guidance on using market authorisation evidence from comparable overseas regulators or assessment bodies.
Manufacturing for export
If a medical device is to be exported from Australia, it needs to be included in the ARTG, even if it is:
- not intended for commercial supply in Australia
- manufactured outside Australia and imported, before being exported.
If a medical device being exported from Australia is not intended for commercial supply in Australia, it must be included in the ARTG as a Class I medical device (export only), or a Class 1 IVD medical device (export only).
You should also consider applying for export certification in the form of a Certificate of Free Sale or Export Certificate for a medical device, regardless of whether the medical device you intend to export from Australia is already on the ARTG or not.