TGA Australia Medical Device Registration & Approval

Medical devices and IVDs sold in Australia are regulated by the Therapeutic Goods Administration (TGA) under the Australian Department of Health. The primary medical device regulations are the Therapeutic Goods Act of 1989 and Therapeutic Goods (Medical Devices) Regulations 2002.

Devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be marketed. Inclusion requires a conformity assessment, either by the TGA or via prior approval from an accepted reference authority, including EU Notified Bodies (CE), the US (FDA), Japan (PMDA), Canada (Health Canada), Singapore (HSA), and Medical Device Single Audit Program (MDSAP) Auditing Organizations.

Foreign manufacturers must appoint a local representative known as the Australian Sponsor. The Sponsor is the Australia-based legal entity responsible for any foreign therapeutic goods entering the Australian market.

Australia TGA Medical Device Classification

A risk-based classification system is used to determine regulatory requirements for medical devices and IVDs. Medical devices are classified as class I, IIa, IIb, and III; IVDs are classified as Class A, B, C, D.

TGA medical device regulatory pathway

Australia has two regulatory pathways: Full TGA Conformity Assessment or the Abridged pathway, which requires approval in an accepted reference market. The Abridged route can shorten review timelines but may still be subject to random and mandatory application audits (for higher risk devices).

TGA Conformity Assessment Route (All classes of medical devices and IVDs)

• Process: A Sponsor submits a complete application via the TGA Business Services (TBS) Portal for inclusion in the ARTG. A TGA conformity assessment is required to confirm an appropriate quality management system (QMS), that the device conforms to the Essential Principles (EPs), and adherence to TGA's safety and performance criteria.

• Requirements: Documentation includes a technical dossier compliant with TGA specifications, TGA Conformity Assessment Certificate (CAC), Manufacturer Evidence (ME) (i.e., proof of QMS conformity), and clinical evidence.

• Timeline: Review times vary based on device risk and whether the application is selected for audit. Higher-risk devices can take longer to review.

• Renewal: ARTG listings do not expire but require an annual maintenance fee. TGA Conformity Assessment Certificates must be renewed every five years.

Abridged Route (All classes of medical devices and IVDs)

• Process: Sponsor submits a complete application to the TGA Business Services (TBS) Portal for inclusion in the ARTG. Foreign conformity assessment certificates are accepted in lieu of TGA Conformity Assessment.

• Requirements: Documentation includes a technical dossier compliant with TGA specifications, Manufacturer Evidence (ME), proof of conformity with the Essential Principles, Declaration of Conformity (DoC)), and proof of reference market approval. Specific documentation requirements depend on your device classification and reference market.

• Timeline: Review times vary based on device risk and whether the application is selected for audit. Higher-risk devices can take longer to review.

• Renewal: ARTG listings do not expire but require an annual maintenance fee. Supporting conformity assessment certificates from reference markets must be kept current.

Key TGA registration requirements

• Australian Sponsor: Required for all foreign manufacturers and must be an Australia-based entity. The Sponsor submits the application to TGA, maintains compliance, and serves as the local regulatory representative.

• Distributor and importer designation: Manufacturers may assign distributors or importers separately from the Sponsor.

• Translation: Documentation must be in English. Device labels and Instructions for Use must be in English in line Australian labeling standards.

• Manufacturer Evidence (ME): The Sponsor must submit proof of QMS compliance (i.e., Manufacturer Evidence) and obtain a Manufacturer Evidence identifier, a unique number issued by TGA confirming your QMS documentation is accepted, before you can apply for ARTG inclusion.

• Post-market obligations: Sponsors must monitor device performance and report adverse events through the TGA Business Portal.

What documentation is required to register a medical device or IVD in Australia?

Specific documentation requirements vary depending on your device classification and whether you are pursuing TGA Conformity Assessment or the Abridged pathway. To register a device with the TGA, the following are typically required:

• A complete technical dossier prepared in accordance with TGA standards

• Manufacturer Evidence (e.g., CE Certificate or MDSAP certificate)

• Proof of conformity with the TGA Essential Principles (EPs), including the Australia DoC, technical documentation, clinical evidence, etc. depending on the device

Only then, the ARTG inclusion application may be submitted, and payment of government fees is completed. Without the payment, TGA will not process the ARTG inclusion application.

TGA may request additional documentation during review, especially for higher-risk products or applications selected for audit.

What is an Australian Sponsor and why do you need one?

An Australian Sponsor is a legal entity based in Australia that acts as the regulatory representative for foreign medical device manufacturers. The Sponsor is responsible for submitting device applications to the TGA, supporting the manufacturer to maintain compliance, facilitating adverse event reporting, and managing post-market obligations. Without a Sponsor, foreign manufacturers cannot obtain ARTG inclusion.

What is Manufacturer Evidence?

Manufacturer Evidence (ME) is proof that a medical device manufacturer has an appropriate QMS and has followed the required conformity assessment procedures. QMS documentation submitted as ME can include QMS conformity assessment certificates from EU Notified Bodies, the US, Japan, Canada, Singapore, and Medical Device Single Audit Program (MDSAP) Auditing Organizations. The Australian sponsor submits these documents through the TGA Business Services portal to obtain a Manufacturer Evidence identifier, which must be referenced in ARTG applications. Without the Manufacturer Evidence approval, the ARTG inclusion application may not be submitted.

What is a TGA application audit?

A TGA application audit is an additional regulatory review conducted after preliminary assessment for inclusion in the ARTG. TGA examines technical, clinical, and regulatory evidence more closely to confirm safety, performance, and compliance. While any application may be audited, the TGA uses a risk-based approach to select device applications for audits.

There are two types of audits: mandatory and non-mandatory. Mandatory audits are required by regulation for certain higher-risk applications, including specific Class III devices supported by EU MDD or US 510(k) approvals, certain system or procedure packs containing higher-risk components, and certain higher-risk IVDs. These audits typically involve detailed review of technical documentation and evidence, carrying an additional fee to be paid to TGA. Non-mandatory (discretionary) audits may be applied to any device based on risk criteria such as device characteristics, regulatory reform priorities, quality of submitted documentation, post-market safety signals, or concerns related to the sponsor or manufacturer. The TGA can expand or waive an audit depending on evidence. No fee currently applies to non-mandatory audits.