Australian medical device regulations alignment with the EU – April 2023

Since the 2015 Expert Review of Medicines and Medical Devices Regulation, the TGA has been making changes to the Australian regulations to align with the latest EU MDR and IVDR

By Val Theisz

The first Australian medical device regulations were published in 2002. They were modelled on the EU Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), and the Global Harmonization Task Force (GHTF) guidance documents published at the time. The Australian medical device regulations cover medical devices, active implantables, and IVDs.

While not identical with the EU directives or the GHTF guidance documents, the Australian medical device regulations introduced similar key regulatory framework elements such as:

• the definition of essential principles of safety and performance
• the definition of general risk classification rules, based on criteria such as:
  • duration of use
  • whether a device is invasive or not
  • whether the device is ‘active’ or not (i.e., operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity)
  • whether the device come in contact with the central circulatory system or central nervous system
• the definition of risk-based conformity assessment pathways for pre-market assessment
• the definition of requirements for post-market compliance

Since adopting a regulatory framework based on EU regulations the TGA has accepted CE Marking approvals as basis for inclusion in the Australian Register of Therapeutic Goods (ARTG).

In 2014, an independent expert panel conducted a review of the Australian medicines and medical devices regulations. The following year year two reports were published: a Stage One Report which covered recommendations on the regulatory frameworks for medicines and medical devices, and a Stage Two Report, which covered the regulation of complementary medicines and the advertising framework for therapeutic goods.

Of the 58 recommendations made by the expert panel, 56 were accepted in full or in-principle by the Australian Government, along with a program of reform to facilitate their implementation.

Recommendation twenty stated that the regulation of medical devices should, wherever possible, be aligned with the European Union framework, and any “specific” (different) requirements should be duly justified.

Hence, the TGA has continued its policy of maintaining alignment with EU medical device regulations after the 2017 enactment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) in the EU. The key areas where the TGA has already implemented changes are listed below:

• Medical device software
• Personalized medical devices
• Systems or procedure packs
• Patient implant cards (PIL) and patient information leaflets (PIL) – similar to EU MDR Article 18
• Self-testing IVDs, IVD companion diagnostics
• Stronger post-market monitoring, and post-market reviews
• Reclassification of certain medical devices: mesh implants, spinal implants, medical devices administering medicines and biologics by inhalation, MDs in direct contact with the heart, the central circulatory system (CCS), or the central nervous system (CNS)

Alignment of regulatory frameworks does not mean identical definitions or regulatory requirements. A consequential difference between the EU and Australian definitions is the definition of central circulatory system. The Australian definition for CCS includes iliac blood vessels, whereas the EU definition does not. This has a significant implication for the risk classification and implicitly the pre-market conformity assessment.

For example, a stent implanted in the iliac artery is classified as class IIa in EU and class III in Australia. This means that a CE Marking approval from an EU notified body cannot be used as basis for inclusion in the ARTG in Australia. Class III devices require appropriate clinical data, including data obtained from clinical trials.

To avoid surprises during applications for inclusion in the ARTG, applicants are advised to check the latest TGA regulations and regulatory guidelines. If necessary, a pre-submission with the TGA should be requested to clarify any question the applicant may have.

The TGA Guidance Clinical evidence guidelines: Medical devices of June 2022 is very similar with the EU MDR Annex XIV and the EU MDCG guidelines 2020-5, 2020-13, and 2021-28. A supplementary document provides guidance for clinical evidence required for IVDs.

Since October 2020, the TGA has implemented a new Post Market Review Compliance Dashboard which replaces the previous process of responding to a post-market review and sending associated documentation by email to the TGA. This is expected to enhance post-market data analytics and facilitate a more transparent, efficient, and secure way in which the TGA can notify sponsors of post-market reviews of medical devices.

Other alignment efforts are the implementation of a UDI system which is currently underway. In July 2022, the TGA has launched a so-called ‘Sandpit’ version of the Australian UDI Database (AusUDID). The Sandpit has been provided as an early release for users to provide feedback on the usability and design of the future AusUDID.

At the time of writing this newsletter, the Sandpit is open to all those who are interested in helping the TGA test the AusUDID and provide their feedback.

For more information on the medical devices reforms and their implementation progress, check the TGA website: https://www.tga.gov.au/products/medical-devices/medical-devices-overview/medical-devices-reforms

Australian regulatory pathway for breakthrough innovative medical devices – March 2023

The TGA priority review allows for accelerated access to breakthrough innovative medical devices, provided they meet eligibility criteria and have preliminary clinical trial data

By Val Theisz

New technologies, first-of-their-kind medical devices are usually developed before there are suitable regulations or standards to assess their safety and performance. Waiting until the slow cycle of regulatory renewal takes place only delays patient’s access to potentially lifesaving or life-improving products.

Following the recommendations of an independent review of therapeutic goods regulations in 2015, the TGA has introduced a priority review pathway for novel medical devices. Such priority or accelerated review pathways for emerging technologies already exist in the U.S. and China.

In the U.S. this is called the Breakthrough Devices Program; its goal is to provide patients and health care providers faster access to medical devices offering more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program allows speeding up the development, assessment, and review of such new technologies, while preserving the statutory standards for premarket approval.

It is important to understand that the priority review pathway involves the same level of pre-market regulatory scrutiny, and that it is not intended for incremental improvements of existing devices. The eligibility criteria for the TGA priority review are very similar to those of the U.S. FDA Breakthrough Devices Program. Specifically, the device:

• must be intended for the prevention, diagnosis, or treatment of a life-threatening or seriously debilitating condition
• must address an unmet clinical need in Australian patients,
• must represent a breakthrough technology, or offer a major clinical advantage over existing alternatives,
• for IVDs, the device must offer a major public health benefit to qualify for priority review.

A more detailed explanation of applying the eligibility criteria is provided in the TGA Guidance Priority applicant guidelines for medical devices (including IVDs) of December 2020.

Applications determined by the TGA to meet the eligibility criteria for a priority review pathway are placed at the front of the queue, with a dedicated coordinating assessor that supervises timely assessment and assignment of suitable review experts.

The TGA distinguishes two types of priority applicant determinations:

• Conformity assessment (priority applicant) determination – this is relevant if the applicant wishes to have a TGA-issued conformity assessment certificate as basis for ARTG inclusion. There is no need to apply for a separate medical devices (priority applicant) determination seeking priority consideration.
• Medical devices (priority applicant) determination – should be used if the applicant already has an overseas conformity assessment, and only needs to seek priority consideration in the ARTG inclusion process.

It is recommended to have a pre-submission meeting with the TGA to get some advice on the strength of the proposed application, and what to include in the application for a priority applicant determination. The advice provided during a pre-submission meeting is not binding, and companies should expect any guarantee to be provided during the meeting.

The application for priority review must include a document that addresses the eligibility criteria plus supporting information consisting of summaries (max 20 pages) of:

• relevant background discussion and data
• clinical investigations (summaries of study reports or resultant peer reviewed articles) providing support with reference to the relevant criteria
• other important safety and performance data obtained in the preclinical and/or clinical setting.

When submitting clinical trial data, it is important to ensure that the clinical trial was designed and conducted according to the latest version of ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. Additional considerations for clinical trial data:

• the version (configuration build) of the investigational devices used for clinical trials must be similar/ substantially equivalent to the version being submitted for priority review
• the patient cohort should be relevant to Australian population, especially if the clinical trial was conducted overseas
• the trial must be conducted in accordance with ethical practices defined in The National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (National Statement)

It is very tempting to spread the news far and wide a new, promising technologies pass the proof-of-concept stage. However, innovators must be aware that advertising of unapproved therapeutic goods is illegal in Australia [ref Therapeutic Goods Act 1989 section 42DL (1)].

Manufacturers and/or sponsors of clinical trials aimed at establishing safety and performance of unapproved therapeutic goods are not allowed to advertise those products. They are however allowed to promote the clinical trial itself to encourage patient enrolment, but without specifically mentioning the name of the therapeutic good being used in the trial.

Any advertisement for a clinical trial should be approved by the ethics committee reviewing the trial as specified under section 5.2.23 of the National Statement and section 4.4.1 of the ICH Guideline for Good Clinical Practice.

For therapeutic goods included in the ARTG, advertising must be consistent with the information included in the ARTG entry, and consistent with the indication or the intended purpose of the therapeutic good. When advertising an approved therapeutic good, manufacturers and sponsors must comply with all applicable requirements of the Advertising Code of 2021.

Overview of requirements for running pre-market clinical trials for medical devices in Australia – February 2023

Pre-market clinical trials for medical devices in Australia – CTN and CTA schemes

By Val Theisz

Regulatory requirements defined in the essential principles

Essential principle EP 14 of the Australian Medical Device Regulations requires that the safety and performance of medical devices be supported by clinical evidence. EP 14 states that every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the EPs.

The clinical evaluation procedures in Part 8 of Schedule 3 of the Medical Device Regulations stipulate that the manufacturer must obtain and evaluate clinical data in relation to the device in the form of clinical investigation data or a literature review, or both (clause 8.3).

Clinical investigation data (clause 8.4) includes:

1. documentation in relation to the design, approval, conduct and results of each investigation carried out by the manufacturer in relation to the use of the device in or on a human body;
2. a record of qualitative or quantitative information obtained through observation, measurement, tests, or any other means used to assess the operation of the device; and
3. a written report by an expert in the relevant field, being a report that contains a critical evaluation of all the clinical investigation data held in relation to the device.

If clinical investigation data is collected in Australia, the investigation must have been conducted in accordance with the ethical standards set out in the ‘National Statement’ relating to ethical conduct in human research published by the National Health and Medical Research Council (NHMRC), as in force at the time (clause 8.4(4)).

If clinical investigation data is collected outside Australia, the investigation must have been conducted in accordance with the principles of the Declaration of Helsinki, as in force at the time and place where the investigation was conducted (clause 8.4(5)).

Before using an investigational device in human subjects, the device must be bench tested and found compliant with the applicable essential principles of safety and performance, except EP 14 which is addressed by providing clinical evidence.

Compliance with Australian or international standards (ISO, IEC) is preferable, but not mandatory, to demonstrate compliance with the relevant EPs, especially for devices based on technologies with well-established safety and performance characteristics.

Clinical data (meaning safety and performance information that is generated from the clinical use of a medical device) may be generated for either the subject device or a comparable device (including substantially equivalent devices). It includes:

• data from clinical investigations (synonymous with trials and/or studies)
• literature reviews
• post-market data
• other clinical experience data (also known as Real World Data).

High risk devices, those based on technologies where there is little or no experience, and those that extend the intended purpose of an existing technology (i.e., a new clinical use) are most likely to require clinical investigation data.

The TGA recognizes international standard ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice as the guidance for conducting clinical trials for medical devices and the necessary documentation to be generated.

Other legislative requirements applicable to clinical trials are the Australian Privacy Act 1998 that covers all activities related to the collection, use or disclosure of personal and sensitive information.

CTN and CTA schemes

Clinical trials can be conducted within Australia under either the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes for devices not currently included in the Australian Register of Therapeutic Goods (ARTG), or to extend the intended purpose of a medical device beyond the current market approval.

The choice between CTN and CTA lies firstly with the trial sponsor and then with the Human Research Ethics Committee (HREC) that approves the protocol. CTN is a notification to the TGA, and as such the TGA does not review or evaluate any data relating to the clinical trial at the time of notification. The notification is done via the online CTN form. After the trial has been completed at all sites, the trial sponsors must notify the TGA that the trial has been completed. Most clinical trials in Australia are notified under the CTN scheme.

CTA is an evaluation process and involves the review by TGA of relevant, but limited, scientific data (which may be preclinical and early clinical data) prior to the start of a trial. For certain Class 4 biologicals, clinical trials must be approved by the TGA under the CTA scheme. CTA applications are submitted using paper-based forms. There are two forms (part 1 and part 2) that must be completed by the sponsor and submitted to us via clinical.trials@health.gov.au .

Approving authorities are public or private legal entities (institutions or organisations) where trials are conducted (i.e., trial sites). Under the CTN and CTA schemes, the approving authority gives the final authorisation for the conduct of the trial at the site following approval by the reviewing HREC.

Private clinics may be used as trial sites for clinical trial purposes and therefore take on the responsibilities of the approving authority. These sites must comply with good clinical practice and all other applicable clinical trial legislation and requirements.

Approving authorities conducting trials under the CTA and CTN schemes have specific responsibilities as outlined in the National Statement, Guideline for Good Clinical Practice and ISO 14155 and the Therapeutic Goods Act 1989.

Finding suitable sites and ethics committees for clinical trials

The Australian Commonwealth Department of Health manages the australianclinicaltrials.gov.au website which provide useful resources for running clinical trials in Australia, including a list with Australian clinical trial sites.

Ethics approval and oversight is provided by HRECs which are often (but not always) located at the site(s) where the clinical trial will take place. Where confirmed by the ethics office, sponsors can use the national human research ethics application (HREA) form prepared by the NHMRC.

The NHMRC maintains a list of registered HRECs that have declared that they are constituted and operate in accordance with the National Statement, as well as a list of certified institutions under its National Certification Scheme of Institutional Processes related to the Ethical Review of Multi-centre research (National Certification Scheme).

Many (but not all) certified institutions are also recognised under the National Mutual Acceptance (NMA) scheme, a system for single ethics review operating in New South Wales, Queensland, South Australia, the Australian Capital Territory and Victoria.

Each Australian state has an ethical review process and information is available from the State and Territory website links below:

• New South Wales
• Queensland
• South Australia
• Victoria
• Western Australia
• Australian Capital Territory
• Northern Territory
• Tasmania

Additional information related to clinical trials

Clinical trials should be registered in a public clinical trials registry at or before the time of first patient enrolment as a condition of consideration for publication. For more information refer to ICMJE clinical trial registration requirements. Registries include clinicaltrials.gov or any registry participating in the WHO International Clinical Trials Registry Platform, such as the Australian New Zealand Clinical Trials Registry (ANZCTR).

A Post-Market Clinical Follow-Up (PMCF) study is a study carried out following marketing authorisation intended to answer specific questions (uncertainties) relating to safety, clinical performance and/or effectiveness of a device when used in accordance with its labelling. Data obtained from PMCF studies are a subset of post-market data. PMCF studies can be used to collect additional clinical data to address the remaining uncertainties about the potential benefits and residual risks of the device.

Advertising of unapproved therapeutic goods is illegal in Australia [ref Therapeutic Goods Act 1989 section 42DL (1)]. Manufacturers and/or sponsors of clinical trials aimed at establishing safety and performance of unapproved therapeutic goods are not allowed to advertise those products. They are however allowed to promote the clinical trial itself to encourage patient enrolment, but without specifically mentioning the name of the therapeutic good being used in the trial.

Any advertisement for a clinical trial should be approved by the ethics committee reviewing the trial as specified under section 5.2.23 of the National Statement and section 4.4.1 of the ICH Guideline for Good Clinical Practice.

For therapeutic goods included in the ARTG, advertising must be consistent with the information included in the ARTG entry, and consistent with the indication or the intended purpose of the therapeutic good. When advertising an approved therapeutic good, manufacturers and sponsors must comply with all applicable requirements of the Advertising Code of 2021.

Update on Australian regulatory requirements for software-based medical devices – January 2023

TGA is aligning its regulatory framework with the latest developments in software-based medical devices, including artificial intelligence and machine learning, and providing classification criteria for clinical decision support software (CDSS)

By Val Theisz

Software based medical devices are medical devices that either incorporate software or are software themselves – the latter are also known as software as medical device or SaMD. Software that falls under the definition of a medical device is regulated as a medical device by the TGA unless excluded.

Examples of SaMD include computer programs and applications, mobile apps, software as a service (cloud based), websites and browser delivered products. Some SaMD may be an accessory to a medical device. Accessories are regulated as separate medical devices.

Software that is an integral part of a medical device is sometimes referred to as SiMD (software in a medical device) and is usually supplied with the hardware device. The TGA regulates this software as part of that device. Examples include embedded software or firmware in a left ventricular assist device.

Software used to program or control a medical device through a connection, either physical or utilising wireless technology such as Bluetooth or WiFi, has the same risk classification as the medical device. Such software is a medical device in its own right if it is supplied separately from the related device. Examples include clinical software used to program a left ventricular assist device using a PC or laptop.

On 25th February 2021 the TGA implemented regulatory changes for software-based medical devices. These changes include:

• clarifying the boundary of regulated software products, including so-called ‘carve outs’ (through either an exemption or exclusion) from the scope of TGA regulation
  • ‘Exemption’ means that the product is a medical device, it is not required to be included in the ARTG, but TGA retains oversight for advertising, adverse events, and notification. Example: surgical workflow software that describes the steps of a surgical procedure to a surgeon as per accepted clinical guidelines
  • ‘Exclusion’ means that the product is completely unregulated by the TGA. Examples: consumer health products; technology enabling telehealth, healthcare or dispensing; electronic patient data management; laboratory IT systems.
• introducing new classification rules – there is a transition period that applies to the new classification rules for software-based medical devices, which ends on 1st November 2024; details are available in the TGA guidance Regulatory changes for software based medical devices of August 2021

• updating essential principles for software-based medical devices – with new requirements for software identification; cybersecurity; data management; as well as software development, production, and maintenance lifecycle

The intention of these changes was to align with international regulatory best practice while reducing unnecessary regulatory burden where appropriate. International regulatory convergence efforts are underway within the International Medical Device Regulatory Forum (IMDRF). There are two working groups tasked with issuing new or improving existing IMDRF guidance documents:

• WG Software as Medical Device (SaMD) chaired by Health Canada
• WG Artificial Intelligence-based Medical Devices (AI-MD) chaired by South Korea’s Ministry of Food and Drug Safety (MFDS)

• WG Medical Device Cybersecurity co-chaired by U.S. FDA and Health Canada

The largest proportion of SaMD and AI-ML based medical devices are in the clinical decision support software (CDSS) space. In October 2021, the TGA published the guideline Clinical decision support software which clarifies how to determine whether a CDSS is regulated by the TGA.

The basis for the decision whether the CDSS is a medical device regulated by the TGA or not is the intended purpose as stated by the manufacturer. If the software has multiple functions, it is the responsibility of the manufacturer to review the intended purpose of each function and determine whether it meets the definition of a medical device and thus fall under the scope of TGA regulation.

TGA’s Guidance Exemption for Certain Clinical Decision Support Software published in August 2022 provides examples and detailed interpretation of the exemption criteria for certain CDSS, and it complements the general Guidance Clinical decision support software originally published in February 2021 and revised in October 2021.

High risk class software-based medical devices require clinical evaluation based on clinical trials. In this context, clinical trials are performed as a validation using medical data collected from patients rather than testing directly on human subjects. Critical legislative requirements when using patient information are those applying to privacy and data protection, such as the Privacy Act in Australia, the General Data Protection Regulation (GDPR) in the EU, and the Health Insurance Portability and Accountability (HIPAA) Act in the U.S.

Does your vehicle’s systems have wireless sensors or include Wi-Fi and/or Bluetooth functions?

Did you know that many vehicle telematics and communications systems use a Public Mobile Telecommunications Service (PMTS) to communicate?

These devices and systems may need to comply with mandatory standards before they can be supplied to the Australian market.

What are the requirements?

The Australian Communications and Media Authority (ACMA) is the Australian Government regulator for telecommunications and radiocommunications. The ACMA has a range of equipment regulations that may apply.

The ACMA’s labelling notices place obligations on the importer (in Australia) of the equipment into Australia, or the manufacturer (in Australia) of the equipment that must be met before the equipment is able to be supplied in Australia.

The obligations in the labelling notices include the requirement to ensure the equipment complies with applicable standards, keeping records that demonstrate compliance, to register on the national database as a supplier and to label the equipment to show it complies.

There are two labelling notices and a set of general equipment rules by the ACMA which specify obligations for suppliers of equipment. It is possible that all four labelling notices could apply to the supplier of the same piece of equipment.

• Telecommunications (Labelling Notice for Customer Equipment and Customer Cabling) Instrument 2015 (Telecommunications labelling notice)
• Radiocommunications (Compliance Labelling – Devices) Notice 2014 (radio labelling notice)
• Radiocommunications Equipment (General) Rules 2021 (Equipment Rules)

The ACMA labelling notices will specify which standards your equipment must comply with.

What applies to vehicle telematics and communications systems?

The requirements are different depending on regulatory arrangement and labelling notice.

Telecommunications

If the vehicle’s system connects to a PMTS directly (rather than through a separate mobile phone) the supplier will need to ensure the system complies with the relevant standards mandated in the Telecommunications (Labelling Notice for Customer Equipment and Customer Cabling) Instrument 2015.

These standards depend on whether the vehicle’s system is data only or supports voice communications.

Radio standards

The supplier of equipment that uses radiocommunications transmitters will need to ensure the transmitters comply with the standards specified in the Radiocommunications Equipment (General) Rules 2021 to ensure the transmitters will operate on the correct frequencies and with the correct power levels.

The radiocommunications transmitters include Bluetooth, wi-fi, transmitters to connect to a PMTS and any other type of radio transmitter used for communicating information, even if that communication is just between devices.

Electromagnetic Energy (EME)

The supplier of equipment that uses radiocommunications transmitters will also need to ensure the transmitters comply with the standards specified in the Radiocommunications Equipment (General) Rules 2021 to ensure the power levels from the transmitters are safe for people.

Electromagnetic compatibility (EMC)

The ACMA has requirements to limit the possibility of interference to radio services from electrical and electronic systems and internal combustion engines. The supplier obligations and equipment requirements are specified in the Radiocommunications Labelling (Electromagnetic Compatibility) Notice 2017 and the standards mandated in the Radiocommunications (Electromagnetic Compatibility) Standard 2017.

Australian suppliers of vehicles or machines may be exempt from these EMC related requirements if the Australian supplier is a member of a relevant peak industry body – the Federal Chamber of Automotive Industries (FCAI), Truck Industry Council (TIC), Construction and Mining Equipment Industry Group (CMEIG), or the Tractor and Machinery Association of Australia (TMA) – and the vehicle or machine complies with the industry body’s code of practice for EMC.

Supplier obligations

The Australian supplier of the final vehicle will need to comply with the requirements of all relevant ACMA labelling notices such as registering on the national database as a responsible supplier, keeping compliance records and signing a Declaration of Conformity for the vehicle.

Under some of the labelling notices the Australian supplier may not be required to apply a label if they are a member of one of the specified industry peak bodies. Please note that the device or system will still need to comply with all the relevant standards.

What can I do to get assistance?

Market Access can assist you with meeting your obligations.

Market Access (AUS) Pty Ltd (MA) is an independent provider of product compliance services to manufacturers and distributors of electrical and electronic devices. Our specialist and highly experienced team will ensure your products conform with all applicable Australian regulatory requirements to not only minimize any risk of liability but assist your rapid time to market.

If you would like to discuss how MA can assist you with your regulatory requirements, please contact Gunther Theisz at gtheisz@marketaccessaus.com.au or call our office on +61 2 9099-1577.

Our Principal Consultant, Val Theisz, MSc RAC (EU, US) is now fully dedicated to providing medical device consulting services to MedTech companies requiring regulatory and quality management systems support.

Since its establishment in 2010, Market Access has been providing services to medical device importers such as certification of imported electrical medical devices to Australian safety standards, TGA registration and inclusion of medical devices into the ARTG, and compliance training and regulatory workshops. In recent years we have seen an increase in demand for dedicated regulatory and quality management system consultancy services for MedTech start-ups. Our Principal Consultant Val Theisz, MSc RAC (EU, US) is now fully dedicated to providing comprehensive, tailored consultancy services for medical device companies covering:

• Medical devices of all risk classes, including high-risk active implantables and SaMD using artificial intelligence (AI) models
• Key target markets – EU, US, Australia, Canada, Japan
• Setting up quality management systems compliant with ISO 13485, EU MDR and FDA 21 CFR 820 (QSR)
• Submission-ready tech files for EU MDR, FDA 510(k) and PMA
• Premarket regulatory strategy and planning
• Post-market compliance
• Advertising for medical devices, compliance with advertising regulations and codes
• Unique Device Identification (UDI)

No matter how big or small, your medical device project is important to us. Contact Val at val.theisz@marketaccessaus.com.au for more information

When including medical devices into the ARTG, Australian sponsors must identify the applicable GMDN code for their products. The GMDN Agency has made basic membership free since April 1^st 2019. The free GMDN membership allows search of GMDN Codes and provides enquiry services . Additional functionalities and services are available for additional fees.  

According to GMDN website: “The new free Basic membership will allow users access to the GMDN data, while the existing membership charges will remain for manufacturers needing the time-saving and value-added services provided by the GMDN Agency. These include the Term Status Notification service (which automatically updates subscribers to change events), multi-user accounts, data export, access to the higher-level Explorer groups and a priority enquiry service.”