TGA
Therapeutic Goods Administration
NDIS
$36B disability scheme
ISO 13485
Medical device standard
AUD 800
Starting cost
Australia's healthcare sector — the world's 12th largest at $200B+ — includes the Therapeutic Goods Administration (TGA), National Disability Insurance Scheme (NDIS), and state hospital networks. For medical device companies, health IT providers, and NDIS service organizations, ISO certification is the quality management baseline for Australian healthcare procurement.
Australian Healthcare — ISO Requirements
| Authority/Scheme | ISO Requirement |
|---|---|
| TGA ARTG (medical devices) | ISO 13485 for manufacturers; helps ARTG registration |
| NDIS Quality and Safeguards Commission | ISO 9001 supports NDIS Practice Standards compliance |
| State hospital procurement | ISO 9001 for supply and service vendors; ISO 13485 for devices |
| Australian Digital Health Agency | ISO 27001 for vendors with My Health Record access |
EA
Elite Assured Expert Team
Australia Healthcare ISO Specialists
Elite Assured has certified Australian medical device companies, health IT vendors, and NDIS providers with JAS-ANZ-aligned ISO certificates. From AUD 800.
Get ISO Certified in Australia Today!
IAF CertSearch verifiable · JAS-ANZ (Joint Accreditation System of Australia and New Zealand) aligned · From AUD 800 · Fully online
Frequently Asked Questions
ISO 13485 is not legally mandated by TGA but is the recognized international quality management standard for medical device manufacturers. TGA's conformity assessment procedures align with ISO 13485 requirements. Having ISO 13485 significantly strengthens TGA applications and is effectively required by most hospital procurement authorities.
NDIS Quality and Safeguards Commission evaluates quality management systems during registration. ISO 9001 provides documented quality management that directly supports NDIS Practice Standards compliance — particularly for governance, risk management, and continuous improvement.