Australia TGA Medical Device Registration – Overview

Medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). For a product to be legally supplied in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG). All foreign manufacturers must appoint an Australian TGA Sponsor a locally established entity responsible for submitting applications, managing ongoing compliance, and acting as the liaison with TGA.

Masuu Global Solutions supports manufacturers across the full TGA regulatory process, helping companies achieve efficient, compliant, and timely ARTG inclusion.

Australia Medical Device Regulatory Framework

Regulatory Authority:

Therapeutic Goods Administration (TGA)

Primary Regulation:

Australian Therapeutic Goods (Medical Devices) Regulations 2002

Regulatory Pathway:

ARTG Inclusion (TGA conformity assessment + sponsor submission)

Authorized Representative Requirement:

Australian Sponsor (mandatory for non‑Australian manufacturers)

QMS Requirement:

ISO 13485:2016 or MDSAP certification

Technical Review:

TGA assessment of evidence, testing, and conformity documentation

License Validity:

Registration remains valid indefinitely, provided annual ARTG fees are paid

Labeling Requirements:

Compliance with Essential Principle 13, Schedule 1 of the Regulations

Submission Format:

Electronic submission through TGA Business Services (TBS)

Submission Language:

English

TGA Medical Device Classification

Australia’s medical device classification framework is closely aligned with the EU system, categorizing devices by risk level.

Non‑IVD Medical Device Classes

Class Risk Level
Class I Low Risk
Class IIa Low–Moderate Risk
Class IIb Moderate–High Risk
Class III High Risk
AIMD High Risk (Active Implantable Devices)

IVD Device Classes

Class Risk Level
Class 1 No public health risk / Low personal risk
Class 2 Low public health risk / Moderate personal risk
Class 3 Moderate public health risk / High personal risk
Class 4 High public health risk

Medical Device Sponsor Requirements

In Australia, the manufacturer must partner with a TGA‑recognized Sponsor who:
  • Acts as the regulatory representative
  • Submits ARTG inclusion applications
  • Maintains all documentation for inspections
  • Communicates with the TGA on behalf of the manufacturer
  • Ensures post‑market compliance

Australia Medical Device Registration Process

  1. Class I Devices

    2. For Class I non‑sterile, non‑measuring devices:
    • The manufacturer submits a Declaration of Conformity
    • The Sponsor files for ARTG listing via TBS
    • ARTG inclusion is typically immediate

  1. Higher‑Risk Devices (Class IIa, IIb, III, AIMD, IVDs)

    2. The Sponsor must provide:
    • Australian Declaration of Conformity
    • QMS certification (ISO 13485:2016 or MDSAP)
    • Evidence of conformity (e.g., CE certificate, GHTF/MDSAP audit reports)
    Mandatory audits apply to:
    • Class III & AIMD
    • Specified Class IIb devices
    • Class 4 IVDs
    • Selected Class 3 IVD categories
    Following successful review, TGA issues the ARTG inclusion number and certificate.

Post‑Approval Lifecycle Management (Australia)

Masuu supports full lifecycle compliance, including:
  • Change management for device variations, accessories, and new indications
  • Annual ARTG fee management
  • License renewals and amendments
  • Ongoing communication with TGA
  • Compliance monitoring and regulatory intelligence
  • Maintaining product safety and performance documentation
We ensure your products continue to meet TGA expectations throughout their lifecycle.

TGA Registration Summary

Risk Level Device Class QMS Audit Requirement Regulatory Pathway TGA Timelines
Low Class I Not Applicable ARTG Listing Immediate
Low–Moderate Class IIa ISO 13485 / MDSAP ARTG Listing 230–250 TGA working days
Moderate–High Class IIb ISO 13485 / MDSAP ARTG Listing 230–250 TGA working days
High Class III ISO 13485 / MDSAP ARTG Listing 230–250 TGA working days

Masuu’s Medical Device Registration Services for Australia

Regulatory Support

  • TGA Pre‑Submission Meetings
  • TGA device classification & grouping
  • Conformity assessment guidance
  • MDSAP implementation support
  • ARTG inclusion support

Documentation & Compliance

  • Labeling compliance review
  • Technical documentation support
  • Internal audits, mock audits & QMS readiness checks

Representation & Operations

  • Australian Sponsor support
  • E‑Business System (TBS) account setup & management
  • Distributor identification & qualification
  • Post‑market surveillance & reporting
  • License renewal & transfer
  • End‑to‑end submission & TGA communication
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