TGA ARTG Medical Device Inclusion Process: Sponsor Step-by-Step Guide

Quick answer

To legally supply a medical device (including an in vitro diagnostic medical device, or IVD) in Australia, the sponsor—a recognised Australian-based legal entity—must obtain inclusion in the Australian Register of Therapeutic Goods (ARTG) through the Therapeutic Goods Administration (TGA). Applications are submitted via TGA Business Services (TBS) at business.tga.gov.au. Before drafting an inclusion application, most sponsors must obtain accepted Manufacturer Evidence for the manufacturing site’s quality management system. You then apply to include a kind of medical device at the correct risk classification, attach conformity assessment documents required for that class, pay the application fee, and pass preliminary assessment under section 41FDB of the Therapeutic Goods Act 1989. The TGA typically decides preliminary assessment within 20 business days. Approved applications yield an ARTG entry and certificate of inclusion; you may then supply the device while meeting ongoing post-market obligations.

Who this applies to

This workflow applies to sponsors—the person or company that imports, exports, or manufactures therapeutic goods for supply in Australia under the Therapeutic Goods Act 1989. To act as sponsor for a medical device, you must be a recognised Australian-based legal entity. Overseas manufacturers cannot sponsor their own devices; they must appoint an Australian sponsor through a formal agreement that gives the sponsor access to regulatory, technical, clinical, and safety documentation.

The inclusion process covers:

• General medical devices (non-IVD): Class I, Class IIa, Class IIb, and Class III
• Active implantable medical devices (AIMD)
• In vitro diagnostic (IVD) medical devices: Class 1, Class 2, Class 3, and Class 4 IVD
• Systems and procedure packs (classified by the highest-risk component)
• Personalised medical devices where ARTG inclusion is required
• Devices supplied in Australia (export-only devices follow different classification and fee rules)

Most medical devices must be included in the ARTG before supply. Exemptions exist for certain exempt or excluded products; confirm status before applying.

What is the ARTG and what is a “kind of medical device”?

The Australian Register of Therapeutic Goods (ARTG) is the TGA’s public register of therapeutic goods approved for supply in Australia. An ARTG entry is identified by an ARTG number and records the sponsor, manufacturer, classification, GMDN term, intended purpose, and product identifiers for a kind of medical device—not a single catalogue item in isolation.

A kind of medical device groups devices that share the same manufacturer, classification, intended purpose, design, and key attributes. Variants (sizes, models, software versions) typically sit under one kind entry. Determining the correct kind boundary affects evidence requirements, audit risk, and variation workflows later.

Australian sponsor: role and manufacturer relationship

Under TGA guidance on the medical device inclusion process, before applying you must establish a relationship with the manufacturer to:

• Obtain documentation demonstrating the kind of device complies with Australian regulatory requirements
• Provide regulatory, technical, clinical, and safety information the TGA may request at any time while you supply the device
• Receive notification of problems, safety alerts, or recalls

The sponsor is the official supplier responsible for ARTG inclusion, adverse event reporting, recall actions, and maintaining access to technical documentation under sections 41FH and 41JA of the Act. Manufacturer and sponsor responsibilities are distinct: the manufacturer holds design and production evidence; the sponsor holds the ARTG entry and Australian market-facing obligations.

Classification paths: how class drives your application

Classification determines minimum conformity assessment evidence and preliminary assessment attachments. Manufacturers classify devices; sponsors enter the class in TBS. Australian rules in the Therapeutic Goods (Medical Devices) Regulations 2002 (Schedules 2 and 2A, Regulation 3.1) may differ from EU or US classification for the same product.

Non-IVD medical devices (four tiers)

Special Class I sub-categories affect evidence:

• Class I supplied sterile — higher evidence than non-sterile Class I
• Class I with a measuring function — higher evidence than non-measuring Class I
• Class I non-sterile, non-measuring — sponsors submit the manufacturer’s Declaration of Conformity with the inclusion application; Manufacturer Evidence is not required before application (per TGA steps-to-supply guidance)

Devices for export only (not supplied in Australia) are classified as Class I under Australian rules.

IVD medical devices (four tiers)

Class 1 IVD devices not intended for self-testing or point-of-care testing may be included via a streamlined self-declaration process: submit the electronic application and fee without additional documents at inclusion time, but maintain documentation for TGA request.

Self-testing and point-of-care IVDs attract higher scrutiny and mandatory audit rules for certain evidence types.

Classification resources

Apply classification principles (Regulation 3.3), rules (Schedule 2 or 2A), and dictionary definitions. TGA publishes separate guidance for non-IVD devices, active/software devices, and IVDs. Identical hardware can classify differently based on intended purpose.

TGA Business Services (TBS): your application portal

All medical device inclusion applications are managed through TGA Business Services (TBS). You need a Client ID and TBS account before submitting Manufacturer Evidence or ARTG applications.

TBS is used for:

• Manufacturer Evidence applications and viewing accepted evidence
• Medical device inclusion applications (draft, submit, pay fees)
• ARTG entry variations and certain change requests
• Printing certificates of inclusion
• Ongoing compliance interactions

Set up and maintain your account per TGA Business Services guidance on tga.gov.au. Sponsors view accepted Manufacturer Evidence under Your TGA information → Medical Device Evidence and note the Manufacturer Evidence identifier required for inclusion applications.

Manufacturer Evidence: prerequisite for most applications

Manufacturer Evidence is a conformity assessment document relating to the manufacturer’s quality management system (or a Declaration of Conformity for certain system/procedure packs under clause 7.5 of Schedule 3). Without accepted evidence, the device cannot be included on the ARTG.

Acceptable Manufacturer Evidence (depending on device class) includes:

• A TGA Conformity Assessment Certificate
• Overseas market authorisation evidence or QMS conformity assessment from a comparable overseas regulator
• Declaration of Conformity to clause 7.5 of Schedule 3 for system/procedure packs

Process:

1. Sponsor submits Manufacturer Evidence through TBS
2. TGA assesses and accepts (or requests information)
3. Sponsor receives a Manufacturer Evidence identifier unique to that evidence
4. Sponsor links the identifier when drafting the inclusion application

Exceptions: Class I non-sterile, non-measuring devices and eligible Class 1 IVDs do not require Manufacturer Evidence before application. All other devices need accepted Manufacturer Evidence before you can begin drafting the inclusion application in TBS.

Update Manufacturer Evidence when applying for new device kinds, when existing evidence is outdated, or when manufacturer name/address changes (same legal entity, same QMS).

Documents for preliminary assessment

Preliminary assessment checks whether your application meets section 41FDB requirements. Applications that fail are refused.

You must:

• Apply in the approved form and manner for the device class (TBS electronic application)
• Attach information prescribed for the class in Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) — consult Table 2 for mandatory attachments
• Provide Manufacturer Evidence (accepted beforehand) or attach it as specified

Typical conformity assessment documents demonstrate:

• The manufacturer has an appropriate QMS for devices of that kind
• Where applicable, product assessment evidence exists (EC certificates, TGA certificates, notified body certificates, MRA certificates, declarations under Schedule 3)

Beyond attachments, sponsors must hold access to documentation the TGA may request under sections 41FH and 41JA, including labelling, instructions for use (IFU), advertising material, and performance evidence.

Class III applications: TGA requires the Clinical Evaluation Report (CER) and IFU with the application (except where TGA-issued conformity assessment certificates apply). Certain Class III pathways supported by MDSAP + FDA 510(k) evidence trigger mandatory Level 2 audits with additional fees.

The Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 specifies information that must accompany applications.

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