Testing, TGA and NATA
Whilst there is no requirement for many items on sale to be tested to Australian Standards, compliance with Australian and International standards demonstrates:
- Products can be relied upon as quality products that will stand the test of time and perform to expectations (strength, reliability and endurance is assured).
- Products that have been certified to these standards have been assessed independently from the manufacturer.
- Certified products have traceability to both the manufacturer and supplier in Australia if there is a problem.
Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) regulates the supply of medical and therapeutics goods within Australia. Proof of successful testing to standards can be an important aspect of application for certification by the TGA.
Novitatech continues to liaise with the TGA with regard to the impact of the regulations on the custom manufactured and general assistive technology sector. Questions with regard to failed equipment should be directed to the TGA Medical Devices group in the first instance.
On the TGA website, you will find information such as:
- links to the legislation and other guidelines
- registration forms
- a link to the Australian Register of Therapeutic Goods (ARTG)
- a link to Device Electronic Application Lodgement (DEAL)
- information on how to report a problem with a medical device.
National Association of Testing Authorities (NATA)
National Association of Testing Authorities (NATA) is the authority that provides independent assurance of technical competence of testing services, through a proven network of best practice industry experts. They provide accreditation services to laboratories and technical facilities throughout Australia and internationally.
Novitatech’s Test Laboratory has NATA registration for the wide range of rehabilitation equipment covered by the Australian Standards.
For more about NATA please visit their website.