Australia TGA Medical Device Regulations

Our regulatory consulting specialists support regulatory compliance with the Australia TGA Medical Device Regulations

Therapeutic Goods Act 1989

Australia TGA Medical Device Regulations

The Australian governing authority, the Department of Health and Aged Care, Therapeutic Goods Administration (TGA) Medical Device Regulations, is responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods in the Therapeutic Goods Act 1989. The TGA regulates medicines, medical devices, and biologicals.

Before you can enter the market, you first have to determine if the Therapeutic Goods Act 1989 applies to your device. When it does, start building up your technical documentation to ultimately receive TGA approval, which will allow you to supply your devices in the Australian market. Market Access/Australia TGV Medical Device Regulations.jpg?preset=content

Australia is part of the Medical Device Single Audit Program (MDSAP). Manufacturers have to obtain MDSAP certification with Australia in scope or otherwise ensure that their QMS is certified according to the Australian requirements.

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:

  • All disinfectors are classified as Class IIb in Australia. 
  • Depending on the duration of the contact, the classification of devices that are in contact with the central nervous system (CNS) is different from the EU, where all these devices are classified as Class III devices.
  • 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 audits of the facility by the TGA.
  • 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 need to determine their device's risk class based on the classification rules as 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.

Medical Device Approval Australia

Australia TGA Medical Device Regulations

The following steps need to be taken by the manufacturer to receive TGA approval:
  1. Determine the risk classification of the medical device or IVD. Depending on the risk classification rules, the risk class may differ in Australia compared to other countries. Also, determine if your medical device or IVD needs to be included in the Australian Register of Therapeutic Goods, the ARTG.
  2. Foreign manufacturers must appoint an Australian Sponsor who liaises between foreign manufacturers and the TGA. 
  3. Choose your regulatory pathway: Full conformity assessment route or Abridged route. 
  4. Prepare technical file documentation, including Australia-specific documents, and update your quality management.
  5. Submit your application and wait for TGA approval. Depending on the type of device and risk class, the TGA may ask you several rounds of questions and answers ('review phase'). Upon TGA approval, the ARTG listing number and certificate will be issued.



Do you need assistance with your strategy for the Australia TGA Medical Device Regulations? 

Qserve is your trusted partner for Australian market access.

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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. 

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Qserve services for Australia

  • Global Regulatory Strategy
  • Registration support in Australia
  • TGA certification
  • Australia sponsor support
  • Translation label and IFUs based on requirements
  • Conformity Assessment route support
  • Abridged route support for CE, FDA, and MDSAP compliance

Qserve knows the essential requirements to ensure how to achieve regulatory compliance.  


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:
  • Apply to the TGA to have therapeutic goods included in the ARTG
  • Notify the TGA of any incidents and performance issues
  • Assist the TGA and the manufacturer with investigations
  • Maintain distribution records for products supplied to Australia
  • Include their name and address on the labels and IFU

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Additional Regulatory Requirements

Required Registration Documentation

The required documentation depends on the registration route and risk class. Overall, you need to consider the following documents:

  • Labels, instructions for use (IFU), packaging
  • Patient information leaflet
  • Cards for implantable medical devices, if applicable
  • Device classification assessment
  • Risk management reports 
  • Clinical evidence plan and reports
  • Validation and Verification Test Reports
  • QMS certification (e.g., MDSAP certificate or TGA Certificate) 
  • Australian Declaration of Conformity (different templates for every risk class)
  • Australian Essential Principles Checklist
  • Australia-specific post-market surveillance requirements

Regulatory Routes for Australia

Abridged route

Australia has recognized certain overseas regulatory approvals, allowing for a faster device assessment process and decreasing overall review timelines. Products covered under the scope of a CE mark, FDA approval, and certified under MDSAP follow a faster assessment pathway than those without. Approvals from Singapore (expedited and abridged route), Malaysia, and India can also be lodged for TGA approval.

TGA Conformity Assessment route

Is an abridged route not possible for you? You will have to undergo a full TGA review. This is a systematic and ongoing examination of evidence and procedures to ensure that the medical device, or IVD, complies with the TGA's essential principle. The TGA will review your technical documentation and quality management system to obtain approval.

Australia TGA Medical Device Regulations make this country an interesting market to enter if regulatory approvals are owned in other jurisdictions.


Registration Validity

Medical Device Approval Australia

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