Australian Medical Device Regulatory Framework

Legal Framework for Medical Device Regulation in Australia

The foundation of Australia’s medical device regulatory framework is the Therapeutic Goods Act 1989. Based on this legislation, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 have been established. These laws and regulations are designed with the primary objectives of ensuring patient and user safety, guaranteeing the quality, performance, and efficacy of medical devices, promoting innovation and facilitating the rapid introduction of new technologies, and advancing international regulatory harmonization.

These regulations are harmonized with European medical device regulations, particularly in the following key areas: risk-based classification systems, conformity assessment procedures, and essential safety and performance requirements. The TGA is actively working to align Australian Essential Principles with the European General Safety and Performance Requirements (GSPR) from the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).

Medical Device Classification

In Australia, medical devices are classified according to their risk level as follows. Class I (low risk) includes items such as bandages and tongue depressors, and is further subdivided into sterile Class I and Class I with measurement functions. Class IIa (low to moderate risk) includes stethoscopes and ultrasound diagnostic devices. Class IIb (moderate to high risk) includes ventilators and infusion pumps. Class III (high risk) includes cardiac valves and coronary artery stents. AIMD (Active Implantable Medical Devices) includes pacemakers and deep brain stimulation devices.

This classification is determined based on factors such as the intended use of the medical device, the degree of invasiveness to the body, the duration of use, and the presence or absence of an energy source. The classification determination process follows classification rules issued by the TGA, and manufacturers are responsible for determining the appropriate classification of their products. However, consultation with the TGA is recommended in cases of uncertainty.

Market Entry Process for Medical Devices in Australia

1. Registration with the Australian Register of Therapeutic Goods (ARTG)

To legally manufacture, import, export, or supply medical devices in Australia, the device must be registered in the Australian Register of Therapeutic Goods (ARTG). The ARTG is an official database that registers all medical devices that may be legally supplied in Australia, and includes information such as product details, manufacturer information, sponsor information, and intended use.

2. Designation of a Sponsor

Manufacturers based outside Australia must designate a representative known as a “sponsor” within Australia. The sponsor is responsible for the following: lodging applications for ARTG registration, ensuring regulatory compliance, reporting adverse events, implementing product recalls (when necessary), maintaining records (sales, distribution, complaints, etc.), and serving as the communication point with the TGA. According to the definition in the Therapeutic Goods Act 1989, a sponsor is a person who exports a product from Australia, imports a product into Australia, manufactures a product in Australia, or arranges for such activities.

3. Submission of Manufacturer Evidence (ME)

Sponsors must submit documentation providing evidence of the manufacturer’s quality management system to the TGA, referred to as Manufacturer Evidence. The following forms of ME are accepted: TGA-issued Conformity Assessment Certificate, conformity assessment documents issued by equivalent overseas national regulatory authorities. The TGA recognizes overseas regulatory authorities including the European Union (EU CE Marking Certificate under MDR or MDD), the United States (FDA 510(k) clearance or approval), Canada, Japan, and Singapore (HSA registration). Additionally, from October 19, 2024, the Medical Device Single Audit Program (MDSAP) certificate has also been accepted as ME. MDSAP certificates must include Australian requirements, and in some cases such as US FDA 510(k) applications or Class IIa devices exempt from FDA requirements, a combination of such certificates may be required.

4. Conformity Assessment Procedures

Conformity assessment procedures appropriate to each medical device class are required. For Class I (non-sterile, non-measuring) devices, manufacturer self-declaration and creation and maintenance of technical documentation are required. For Class I (sterile, measuring functions), Class IIa, and Class IIb devices, quality management system (QMS) evaluation and technical documentation review are required. For Class III and AIMD devices, comprehensive QMS evaluation, detailed technical documentation review, and design review are mandatory.

From July 1, 2024, the scope of mandatory audits has been significantly reduced. While many device classes were previously subject to mandatory audit, mandatory audits now apply only to Class III medical devices (those using legacy CE Marking Certificates under the former EU MDD or AIMD that remain valid under EU MDR transitional arrangements, or those with MDSAP certificates combined with US FDA 510(k)) and specified IVDs (Class 3 and Class 4 IVDs, Class 4 in-house IVDs, and IVDs for self-testing or point-of-care testing). This represents a strategic shift to concentrate regulatory resources on higher-risk devices and provides manufacturers with faster market access.

5. Creation of a Declaration of Conformity by the Manufacturer

The manufacturer must create a declaration of conformity certifying that the medical device complies with all applicable Essential Principles.

6. Review by the TGA

The TGA reviews the submitted “Manufacturer Evidence” and issues notification of approval or non-approval.

7. Registration with the ARTG

Upon completion of review and confirmation that the medical device is appropriate, it is registered with the ARTG. Importantly, ARTG registration is conducted on a “kind” basis rather than on an individual product basis, allowing a group of products belonging to the same “kind” to be covered by a single ARTG registration.

Australia-Specific Requirements

1. Manufacturer’s Evidence

Sponsors must submit documentation demonstrating that the medical device manufacturer maintains an appropriate quality management system, typically based on ISO 13485:2016.

2. Essential Safety and Performance Requirements (Essential Principles)

All medical devices must comply with the “Essential Safety and Performance Requirements” established by the TGA. The Essential Principles consist of 13 main requirements and multiple sub-requirements, and include the following: general safety and performance requirements, design and manufacturing requirements, labeling and instructions for use requirements, and clinical evaluation and risk management.

In September 2025, the Essential Principles Checklist was updated to the latest version, with the addition of new sections including EP13 (13.5) UDI Device Identifier and UDI Production Identifier, EP13 (13.6) Medical Device Packaging Identifier, and EP13C Rules for UDI Medical Devices. These updates represent important changes to strengthen medical device identification and traceability.

3. Quality Management System (QMS) Requirements

In Australia, implementation of a quality management system based on ISO 13485:2016 is required. Key requirements include the following: establishment of quality policies and quality objectives, clarification of organizational responsibilities and authorities, management of documented procedures and records, design management processes, manufacturing process control, inspection and testing procedures, non-conforming product management, corrective and preventive actions, risk management (in compliance with ISO 14971), internal audits, and management review.

4. Labeling and Instructions for Use Requirements

In Australia, medical device labels must include the following information: manufacturer name and name and address of the Australian sponsor, product name and model number, lot number, batch code, or serial number, expiration date (if applicable), sterilization status and method (for sterilized products), “single use” marking (if applicable), special storage and handling conditions, warnings and cautions, and intended use or indications for use.

Additionally, instructions for use (IFU) must include detailed information such as intended purpose, performance characteristics, contraindications, warnings, and method of use. With the implementation of UDI regulations in 2025, IFUs must also include UDI-related information where applicable.

5. Post-Market Surveillance

After registration with the ARTG, the following continuing obligations apply: reporting of adverse events (within 48 hours, 10 days, 30 days, or 60 days depending on severity), product monitoring and evaluation, record retention, and product recall procedures (when necessary). Since March 1, 2025, the inclusion of UDI in adverse event reports has been mandatory.

Recent Regulatory Developments

1. Acceleration of Medical Device Regulatory Reform

The TGA continues to advance medical device regulatory reforms. While more rigorous review for high-risk devices is being strengthened, audit requirements for lower-risk devices have been significantly simplified. This approach simultaneously ensures the safety of high-risk devices while promoting innovation in lower-risk devices. On July 1, 2024, a major amendment to the Medical Device Regulations (Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024) came into effect, implementing significant reductions in mandatory audit subjects, removal of certain Class IIb devices from the mandatory audit list, and regulatory exemption of prescription spectacle lenses.

2. Implementation of the Unique Device Identification (UDI) System

To strengthen individual device identification and traceability of medical devices, the TGA has implemented a UDI system. The UDI regulations came into effect on March 24, 2025 (Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025). The UDI system represents an Australian-first initiative, with the objectives of improving patient safety, enhancing the accuracy of adverse event reporting, and accelerating recall response.

The UDI consists of the combination of the UDI-DI (Device Identifier), which indicates the manufacturer and device model, and the UDI-PI (Production Identifier), which indicates manufacturing-specific information such as lot number or expiration date. UDI Carriers are required on device labels and all applicable levels of packaging, and for reusable devices (such as scalpels), the UDI must be marked directly on the device itself in both machine-readable and human-readable formats.

Compliance start dates are set in phases according to device risk class. Class III medical devices and AIMD: July 1, 2026. Class IIb medical devices: January 1, 2027. Class IIa medical devices: July 1, 2027 or later. Class I medical devices (sterile and with measurement functions): July 1, 2027 or later. Class I medical devices (non-sterile, non-measuring): excluded from UDI requirements. Shorter transition periods apply to some devices using legacy EU MDD/AIMD and EU IVDD certificates.

Sponsors and manufacturers must submit UDI records to the Australian UDI Database (AusUDID) within 30 days of the device being supplied to the Australian market. AusUDID is a public database through which patients, consumers, and healthcare professionals can access device information.

3. Clarification of Software-Based Medical Device (SaMD) Regulation

To respond to the evolution of digital health, the TGA continuously updates the regulatory framework for software-based medical devices (Software as a Medical Device, SaMD). The regulations introduced in February 2021 establish special requirements for software validation, cybersecurity measures, and software update management.

Essential Principle 13B has been updated to strengthen traceability of medical device software, requiring that software version and build numbers be clearly identifiable and accessible to users. Version information must be provided primarily in English and must be maintained throughout the device’s lifecycle. Additionally, in August 2025, new regulatory guidance was announced for software including artificial intelligence (AI), providing clear guidance on ensuring safety and performance.

The determination of regulatory applicability for software included in medical devices is made based on device definition, medical application, risk of harm, and other factors. Some low-risk devices such as Clinical Decision Support Systems (CDSS) may be excluded from or exempted from regulatory scope.

4. Amendment of Classification Rules for Medical Devices Containing Medical Substances

Effective July 1, 2024, the amended Classification Rule 5.5 applies only to medical devices containing non-viable tissues or cells of animal origin (other than hair or wool-derived) or derivatives thereof. Previously, this rule also applied to devices containing substances of microbial or recombinant origin, but these are now excluded under the amendment. However, devices in contact with intact skin only continue to be excluded. New applications must comply with the amended Classification Rule 5.5 and other applicable classification rules.

5. Continuous Efforts Toward International Harmonization

The TGA actively participates in the following international regulatory harmonization initiatives: the International Medical Device Regulators Forum (IMDRF) to promote regulatory harmonization and convergence, the Medical Device Single Audit Program (MDSAP), through which a single quality system audit satisfies the regulatory requirements of multiple countries (with participation from Australia, Brazil, Canada, Japan, and the United States), mutual recognition agreements (MRA) with the European Commission, information-sharing agreements with the US FDA, and cooperative relationships with the Singapore Health Sciences Authority (HSA) and Canada.

Through these international collaborations, reduction of redundant regulatory requirements, acceleration of market access, sharing of international best practices, and strengthening of global product safety surveillance are being realized. The TGA’s acceptance of Singapore Health Sciences Authority (HSA) registration represents an important advancement in strengthening international harmonization and mutual recognition efforts.

6. Regulatory Framework for Personalized Medical Devices

The definition of custom-made medical devices has been updated, introducing a new category called “Personalized Medical Devices.” This category is subject to individual conformity assessment procedures, conformity declarations, annual reporting obligations, and other requirements.

7. Continuous Improvement of ARTG Online Registration System

The TGA continuously improves and updates its online system for ARTG registration applications. It is recommended to refer to the TGA’s official website and the Australian Regulatory Guidelines for Medical Devices (ARGMD) for information on the latest system changes and updates.

Post-Market Regulation of Medical Devices in Australia

The main post-market regulations for medical devices in Australia are as follows.

1. Adverse Event Reporting

Adverse event reporting for medical devices is conducted in accordance with the Therapeutic Goods (Medical Devices) Regulations 2002. Reporting deadlines vary depending on the severity of the event. Events indicating serious threats to public health must be reported within 48 hours. Events resulting in death or serious deterioration in health status must be reported within 10 days. Events that could result in death or serious deterioration in health status if repeated must be reported within 30 days. Other reportable information must be reported within 60 days.

From March 1, 2025, all adverse event reports must include the UDI (where applicable). This aims to improve patient safety and the accuracy of event tracking.

2. Product Recalls

Recall measures in Australia are implemented in accordance with the “Uniform Recall Procedure for Therapeutic Goods (URPTG).” Recalls are classified into the following categories. Class I (most serious safety-related: where there is a reasonable possibility of death or serious health deterioration), Class II (urgent safety-related: where there is a possibility of temporary or medically reversible adverse health effects), Class III (lowest risk: where there is a low possibility of causing adverse health effects).

The URPTG defines the recall process in 10 steps, including information gathering, risk analysis, recall strategy development, notification to the TGA, implementation, reporting, and review. With the implementation of the UDI system, rapid and accurate identification of devices subject to recall is expected to become possible.

Conclusion

Australia’s medical device regulatory environment is evolving rapidly with the dual objective of ensuring patient safety and improving regulatory efficiency. The implementation of the UDI system, rationalization of mandatory audit requirements, and advancement of international regulatory harmonization bring new requirements for manufacturers while providing clear pathways for assured market access. It is important for sponsors and manufacturers to regularly review the TGA’s official guidance and the Australian Regulatory Guidelines for Medical Devices (ARGMD) and respond to the latest regulatory requirements and implementation deadlines.