Australian Medical Device Registration: The Role of the Sponsor and TGA Inclusion

Australian Medical Device Registration: The Role of the Sponsor and TGA Inclusion

Medical device registration in Australia is overseen by the Therapeutic Goods Administration (TGA), which is part of the Australian Government's Department of Health. Non-Australian manufacturers must utilize an Australian Sponsor (or Authorized Representative) to facilitate the registration process and maintain compliance.

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The Role of the Australian Sponsor

The Australian Sponsor is the primary local contact for the TGA and acts as the legal conduit between the manufacturer and the TGA. Their responsibilities include:

• Submitting the application for inclusion in the Australian Register of Therapeutic Goods (ARTG).
• Answering any questions from the TGA during the application and review process.
• Providing ongoing post-market surveillance and vigilance support.
• Ensuring the device maintains compliance with Australian regulations.

Registration Pathway and Essential Principles

To achieve ARTG inclusion, manufacturers must demonstrate that their medical device complies with the Essential Principles set out in the Therapeutic Goods Act 1989. These include six general principles that apply to all devices (e.g., safety, suitability for intended purpose) and nine further principles that apply on a case-by-case basis (e.g., chemical properties, clinical evidence).

The TGA offers an abridged regulatory review for products that have already demonstrated conformity in reference countries, including the European Union, the United States (FDA), Canada, Japan, and Singapore. Acceptable evidence of conformity to the Essential Principles includes:

• Certificates issued by EU Notified Bodies.
• Decisions by the U.S. Food and Drug Administration (FDA).
• Approvals and licenses issued by Health Canada.
• Certificates and reports issued under the Medical Device Single Audit Program (MDSAP).

Application and Audit Requirements

The TGA's regulatory review time and mandatory audit requirements depend on the device's risk classification (Class I, IIa, IIb, III, and Active Implantable Medical Devices - AIMD).

Review Times and Fees (AUD)

Device Classification	Application Fee (AUD)	Estimated Review Time
Class I (sterile/measuring function)	$621	Same day to 4 weeks
Class IIa	$1,187	4 weeks
Class IIb	$1,187	6 weeks
Class III	$1,530	6 months (incl. audit)

Application Audit Assessment

Higher-risk products are subject to a mandatory audit where the TGA reviews the application and technical documentation:

• Level 1 Audit (Verification): Verifies the sponsor's application and evidence of conformity (Fee: A$4,700).
• Level 2 Audit (Mandatory for Class III and AIMD): Includes Level 1 activities plus an in-depth technical documentation review (Fee: A$17,288).

Annual Fees (AUD)

Annual fees are also mandatory to maintain the device's listing on the ARTG:

Class of Medical Device	Annual Fee (AUD)
AIMD & Class III	$1,566
Class IIb & IIa	$1,230
Class I (sterile or measuring)	$828
Class I (other)	$114

Quality System Requirements

The TGA requires manufacturers to meet ISO 13485:2016 standards, with additional specific requirements for products that are sold sterilized, which must adhere to relevant ISO standards (e.g., ISO 11135 for ethylene oxide sterilization).