Medical Device Market Size
Market Value: Estimated at USD 5.5 billion in 2024, making it one of the top 10 global medtech markets.
Growth Projections: Projected to grow to over USD 7 billion by 2029.
Future Growth Potential
- Aging Demographics: A growing elderly population is expanding demand for diagnostics, surgical, and home care devices.
- Public-Private Mix: Strong health insurance penetration fuels private sector device usage.
- Tech-Friendly Market: Welcomes digital health and telemonitoring innovations.
Registration Process
Regulatory Authority: Therapeutic Goods Administration (TGA)
Device Classification:
- Class I — Low Risk
- Class IIa — Low to Moderate Risk
- Class IIb — Moderate to High Risk
- Class III & AIMD — High Risk
Registration Requirements:
- All devices must be included in the Australian Register of Therapeutic Goods (ARTG).
- Class I devices can be self-certified.
- Class IIa and above must go through conformity assessment and/or mutual recognition.
Local Representation: Foreign manufacturers must appoint an Australian Sponsor to hold the ARTG registration.
Quality Management: ISO 13 485 and TGA GMP compliance are required.
Online Portal: TGA Business Services (TBS) portal — https://www.ebs.tga.gov.au
Language Requirements: English documentation and labeling are required.
Post-Market Surveillance: Mandatory reporting of adverse events, recalls, and incident tracking.