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Australia TGA Medical Device Regulations

Regulatory experts supporting medical device and IVD manufacturers with TGA compliance, registration, and market access in Australia.

Therapeutic Goods Act 1989

Australia TGA Medical Device Regulations

In Australia, the Therapeutic Goods Administration (TGA), part of the Department of Health and Aged Care, ensures the safety, quality, and efficacy of medicines, medical devices, and biologicals. These are regulated under the Therapeutic Goods Act 1989, a key legislative framework that defines and governs therapeutic goods in the country.

Before entering the Australian market, manufacturers must determine whether their product falls under the scope of the Therapeutic Goods Act 1989. If it does, the next step is to build comprehensive technical documentation. This documentation demonstrates that the device meets Australian standards, paving the way for TGA approval, which is essential for legally supplying medical devices.

Australia’s Medical Device Single Audit Program (MDSAP) participation further streamlines the regulatory process. Manufacturers must ensure their Quality Management System (QMS) complies with Australian requirements. This can be achieved by obtaining MDSAP certification with Australia in scope or through a QMS certification tailored to local regulations.

By aligning with these regulatory requirements, manufacturers ensure compliance and gain access to one of the most rigorous and respected healthcare markets globally.

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Services

Qserve services for Australia

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Regulatory Market Access Strategy

We develop customized regulatory strategies to help you enter the Australian market efficiently, ensuring compliance with TGA requirements.

Australia Sponsor Support

Qserve assists in appointing or acting as your local sponsor in Australia, ensuring you meet TGA’s in-country representation requirements.

Translation of Labels and IFUs

We provide compliant translations of product labels and Instructions for Use (IFUs) according to TGA’s formatting and language guidelines.

Set Up Your MDSAP-Compliant QMS

Our experts help you build or align your Quality Management System to meet MDSAP and ISO 13485 standards, recognized by the TGA.

Gap Analysis

We review your technical documentation and QMS to identify gaps against Australian regulatory requirements, ensuring a smooth submission.

Risk Management

Qserve supports the development and maintenance of ISO 14971-compliant risk management files in line with Australian expectations.

Clinical Evaluation

We assist in compiling clinical evidence and evaluations that meet TGA requirements, including literature reviews and performance data.

Post-Market Surveillance (PMS)

Our team helps implement PMS procedures tailored to the Australian market, including vigilance reporting and complaint handling.

Registrations Procress

Our team of experts guides you through the entire TGA registration process, from dossier preparation to approval and post-market obligations.

Medical Device Approval Australia

Australia TGA Medical Device Regulatory Approval Process

The TGA approval process involves several key steps to ensure compliance with Australian regulations.

  1. Determine the Risk Classification
    Start by identifying your device's or IVD's risk classification. Due to specific risk classification rules in Australia, your risk classification may differ from that in other countries.
  2. Appoint an Australian Sponsor
    Foreign manufacturers must appoint a local Australian Sponsor. The Sponsor is the manufacturer and TGA liaison, ensuring smooth communication and regulatory compliance.
  3. Select a Regulatory Pathway
    Choose the appropriate regulatory pathway for your device:
    1. Entire Conformity Assessment Route: A comprehensive review of your device's compliance.
    2. Abridged Route: A streamlined process for devices with approvals in recognized markets.
  4. Prepare Technical Documentation
    Compile a technical file that includes Australia-specific documents. Update your quality management system (QMS) to meet Australian requirements.
  5. Submit the Application
    Submit your application to the TGA and enter the review phase. Depending on your device's risk classification, the TGA may request additional information or clarification.
  6. Receive TGA Approval
    Once approved, the TGA will issue your device's ARTG listing number and certificate.
Medical Device Classification in Australia

Risk-based classification

All medical devices are classified using a risk-based approach comparable to the European Union and FDA classification systems. The range spans Class I (sterile/measuring), IIa, IIb, and III, where Class I (including sterile/medium) is low risk and Class III and AIMDs are high risk.

There are a few exemptions:

  1. All disinfectors are classified as Class IIb in Australia.

  2. Depending on the duration of the contact, devices that are in contact with the central nervous system (CNS) are classified differently from the EU, where all these devices are classified as Class III devices.

  3. Note that a microbiome and recombined origin device, Class III in Australia, must undergo a full conformity assessment. This entails a full technical file review, including the design and the TGA's audits of the facility.

  4. Note that software has a different risk classification, highly dependent on its intended use.

Although the classification system may be comparable to other overseas systems, manufacturers must determine their device's risk class based on the classification rules set by the Australia TGA Medical Device Regulations. Given the differences in interpretation, conducting a classification assessment according to the Australian regulations at an early stage is beneficial.

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Additional Regulatory Requirements

Required Registration Documentation

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Labeling, IFUs, and Packaging

All product labels, instructions for use (IFUs), and packaging must meet Australian regulatory requirements for content, format, and language.

Patient Information Leaflet

A document provided to patients that explains how to safely use the medical device, required for certain classes of devices in Australia.

Implant Card (if applicable)

A card given to patients with implantable devices, containing essential information such as device model, batch number, and manufacturer details.

Device Classification Assessment

The process of determining the risk class of a medical device under TGA rules, which defines the registration and conformity pathway.

Risk Management Reports

Documents demonstrating that risks related to the use of the device have been identified, evaluated, and controlled according to ISO 14971.

Clinical Evidence Plan and Reports

A structured plan and accompanying reports showing that the device is safe and performs as intended, based on clinical data.

Validation and Verification Test Reports

Technical test results that confirm the device meets its design and performance specifications, required for TGA registration.

QMS Certification

A valid certificate (such as MDSAP or a TGA-issued QMS certificate) proving that the manufacturer operates a compliant quality system.

Australian Declaration of Conformity

A formal document declaring that the device complies with Australian regulations, with templates varying by risk class.

Australia-specific post-market surveillance requirements

Ongoing monitoring obligations including complaint handling, adverse event reporting, and corrective actions, tailored to the Australian market.

Australian Essential Principles Checklist

A checklist mapping how the device meets Australia's Essential Principles for safety, quality, and performance.

Representation for foreign manufacturers

Australian Sponsor Requirement

A foreign manufacturer must appoint a sponsor if they want to supply devices in Australia. The sponsor must be a resident of Australia or be an incorporated body conducting business in Australia. This could be your distributor, but appointing an independent third party gets more control of registration and provides more flexibility in changing distributors or appointing multiple distributors for better market penetration.

Your sponsor should:

  1. Apply to the TGA to have therapeutic goods included in the ARTG
  2. Notify the TGA of any incidents and performance issues
  3. Assist the TGA and the manufacturer with investigations
  4. Maintain distribution records for products supplied to Australia
  5. Include their name and address on the labels and IFU
Latest regulatory developments

The TGA clarified its approach to the lapsing of conformity assessment documents due to audit delays (e.g., as a result of COVID-19, EU MDR transition, and limited EU notified body designations).

The TGA no longer accepts ISO 13485 certificates to support applications for new IVD devices, except if the manufacturer made a declaration of conformity under the EU IVDD before 26 May 2022. Approved IVDs supported by ISO 13485 certificates remain valid until the certificate expires.

Proposed application audit

Manufacturers can respond to the open consultation on the proposed application Audit framework for medical devices, including feedback on the following: 

Risk factors informing non-mandatory audit selection

Criteria for mandatory audits

The evidence to be provided with applications to inform audit selection

Limiting the number of substantial assessment rounds

Mechanisms to improve the visibility of application audit timeframes

Cost recovery measures for non-mandatory audits. 

Registration Validity
 

For submissions with Class Is, Im IIa, and IIb that rely on MDSAP, CE, or US FDA, the registration will remain valid if the supporting certifications are still active and within the expiry date of the respective certification.

For the TGA conformity assessment certificate, a validity of five years applies.

Regulatory timelines and fees

How long does it take to enter
the Australian medical device market? 

The review times depend on the risk class and the completeness of the documentation that is provided to the TGA, and if your device is subject to auditing but the overall timelines are as follows:

Class I: 24 hours to 4 weeks

Class Is, Im, IIa, and IIb: 2-4 months

Class III and AIMD: 6-8 months

Full TGA Conformity Assessment: 18-24 months

Regulatory Routes

Regulatory Routes for Australia

Australia offers two primary regulatory pathways for medical device and IVD approval under the TGA Medical Device Regulations: the Abridged Route and the TGA Conformity Assessment Route. Each path is designed to accommodate different prior approvals and device readiness levels.

Abridged Route
The Abridged Route is a faster assessment process for devices already recognized overseas regulatory approvals. This pathway reduces review timelines, making it an efficient option for manufacturers with prior certifications.

Eligible approvals for the abridged route include:

  1. CE Mark
  2. FDA Approval
  3. Certification under the Medical
  4. Device Single Audit Program (MDSAP)
  5. Approvals from Singapore, Malaysia, or India

Manufacturers can streamline their journey to TGA approval and market access by leveraging these existing certifications.

TGA Conformity Assessment Route
If the abridged route is not an option, manufacturers must follow the TGA Conformity Assessment Route. This involves a comprehensive and systematic review by the Therapeutic Goods Administration (TGA). Key elements of the conformity assessment include:

  • Examination of technical documentation to ensure compliance with the TGA’s essential principles.
  • Review of the manufacturer’s quality management system (QMS).
  • Verification that the medical device or IVD meets all regulatory requirements for safety and performance ensures that the product adheres to Australia’s rigorous standards, paving the way for market approval.

Why Consider Australia for Medical Device Market Entry?
Australia’s participation in global regulatory frameworks, such as MDSAP, and its recognition of approvals from other jurisdictions make it an attractive market for manufacturers. With existing certifications, entry can be faster and more efficient, allowing you to capitalize on opportunities in this growing healthcare market.

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