The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. They carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
Here is a brief online overview of the medical device regulatory system in Australia: www.tga.gov.au/sme-assist/medical-devices-regulation-introduction, and series of more detailed online resources to assist people with the regulatory process.
REGULATORY PROCESS
It is basically a three phase system:
- Conformity assessment
- Market authorisation
- Post market
The Australian regulatory guidelines for medical devices provide a good resource on how the regulatory system works.
TGA activities are cost recovered, and there are fees and charges associated with assessment of medical devices and in vitro diagnostic devices (IVDs).
Conformity assessment:
For the vast majority of products TGA may accept overseas conformity assessment (or other overseas regulator approvals). Conformity assessment is a process for the manufacturer, wherever in the world they are located.
- Our comparable overseas regulator arrangements allow for use of certification or approvals from the European Union, the US FDA, Health Canada, Japan, and MDSAP (plus a few other certifications for particular products). Details of what documentation is required from each jurisdiction for each device classification is explained Table 2 of our Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) guidance.
- There is a small subset of high risk devices which must have TGA conformity assessment – these include devices which incorporate a medicine, contain tissues or substances of human blood or plasma, animal, microbial or recombinant origin, or Class 4 IVDs. This assessment (and the associated evaluation fees) may be abridged where overseas regulators have already assessed the product, as outlined in Table 1 of our Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) guidance.
Marketing authorisation:
Before being imported, supplied, exported or advertised in Australia a medical device must be included in the Australian Register of Therapeutic Goods (ARTG), unless an exemption applies. Applications for inclusion require an Australian sponsor, who needs to have an ongoing relationship with the manufacturer.
Once an application for inclusion is submitted TGA has 20 working days to either accept applications for inclusion, or select them for audit, and audit is mandatory for some higher risk products.
Once included in the ARTG the product can be imported, supplied, exported and advertised, subject to ongoing post market requirements.
Post market:
Once a medical device has been included in the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval, and the sponsor must comply with ongoing responsibilities.
There is a Medical Device Information Unit who can field calls or emails about the particulars of individual products and help people with their applications. They can be contacted at devices@tga.gov.au or on 1800 141 144 (free call within Australia).
Israel Trade and Economic Commission in Sydney, Australia 