Key Federal E-Bike Requirements
To be considered a legal, non-motorized vehicle, an e-bike must comply with the following, primarily based on the reinstated EN 15194 standard:

• Motor Power:Maximum continuous rated power of 250 watts.
• Speed Cut-off:Motor assistance must stop when the bike reaches 25 km/h.
• Pedal Assist:The motor must only provide assistance when the rider is pedalling.
• Throttle Usage:Throttles are generally restricted, with permissible models only allowing power up to 6 km/h (walk-assist).
• Safety Standards:Compliance with EN 15194 (European standard) for electrical and mechanical safety.
• Anti-Tampering:New federal rules include requirements for anti-tampering protocols to prevent consumers from modifying the bike for higher speeds.

Key Changes and Trends (2025–2026)

• Import Crackdown:Due to a rise in battery fires and safety incidents, the Federal Government has strengthened import rules to require EN 15194 compliance for all new imported e-bikes.
• Non-Compliant Bikes:Any e-bike that exceeds 250W or provides power above 25 km/h without pedalling is considered an unregistered motor vehicle, with strict penalties (fines over $1,000) and potential, or in some cases (NSW), immediate seizure/destruction by police.

Safety and Operation

• Helmets:A helmet meeting Australian standards is mandatory.
• Battery Safety:Increased focus on lithium-ion battery safety, encouraging the use of certified chargers and discouraging unattended charging.
• Footpaths:Rules for riding on footpaths vary by state/territory, with most allowing it for children under 16, but restrictions exist for adults in places like NSW and Victoria.

Key Australian Customs & Import Regulations for E-Bikes

• Compliant “Bicycle” Definition (No Approval Needed):

• Pedal-Assist (Pedelec):Max 250W continuous power, motor cuts off at 25 km/h.
• Throttle-Controlled:Max 200W continuous power, cannot be propelled solely by the motor (must require pedalling).
• Safety Standards:Compliance with EN15194 (European standard) is heavily required.
• Labelling:The bike should have a sticker/label indicating it meets these standards.

• Import Approval Required: If your e-bike exceeds 200W (throttle) or 250W (pedal-assist), it is classified as a motor vehicle. You must apply for an import approval permit from the Department of Infrastructure, Transport, Regional Development and Communications via the ROVER portal before shipping.

• Customs Process:
  • Duties/GST:Goods with a value of AUD 1000 or less may not incur duties, but GST can apply.
  • Inspection:Australian Border Force (ABF) may inspect, test, or hold bikes that appear to be high-powered/motorbikes, charging storage fees until compliance is proven.

• Document Checklist:

• Manufacturer’s specifications/brochure.
• Certificate of compliance with EN15194.
• Proof of purchase/value.

 

If the bike is over the power/speed limit, it cannot be registered for road use and is limited to private property use only.

Compliant electric bikes (e-bikes) in NSW do not require registration, licensing, or compulsory third-party (CTP) insurance. To be exempt from registration, the e-bike must have a maximum 250-watt pedal-assist motor, or a 200-watt throttle motor that cuts out at 25km/h. There are no registration fees for these compliant bikes.

 

Key Rules for E-Bike Registration in NSW

• Compliant E-bikes (No Fees):If your e-bike meets the power (250W/200W) and speed requirements, it is considered a bicycle under NSW law.
• Non-Compliant/High-Powered Bikes:If an e-bike exceeds these limits, it is classified as a motorbike and must be registered. If used on public roads without registration, penalties range from $686 to $2200.
• Petrol-Powered Bikes:These are generally illegal on NSW roads and public paths.
• Registration Costs (If required for high-powered):Fees for motorcycle-type registration in NSW typically include a registration fee, CTP Green Slip, and potentially a pink slip (if over 5 years old).

 

What can I do to get assistance?

CBA can assist you with meeting your regulatory obligations and provide accredited safety certification.

If you would like to know more on how CBA can assist you with your regulatory requirements, please contact us on 61 2 9099-1557 or email Gunther at gtheisz@certificationbody.com.au or Colin at cpayne@certificationbody.com.au.

For more information, please see our website – www.certificationbody.com.au.

 

 

 

On 5 October, the ACCC released a report “Lithium-ion batteries and consumer product safety”. This report follows on from an ACCC commissioned report by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) on Lithium-ion battery safety (published in May 2023) which sought expert scientific views on product risks and mitigation measures for Li-ion batteries.

In its report, the ACCC is seeking to demonstrate the importance of safe battery supply and design to support consumer confidence in the safety of Li-ion products.

The report examines the risks and hazards associated with Li-ion batteries, the available incident data, the current Li-ion battery market and the regulatory landscape governing Li-ion batteries in Australia.

The report states that the ACCC has received 231 product safety reports relating to Li-ion batteries between 1 April 2017 and 31 March 2023. There have been 23 recalls between 1 January 2017 and 31 December 2022 involving Li-ion batteries and products containing them. These recalls affect an estimated 89,000 products on the market.

The report makes a number of recommendations to address the risks and hazards associated with Li-ion batteries. These recommendations cover improving data collection practices, clear and accessible educational resources on Li-ion battery safety for consumers and fit for purpose regulatory frameworks for Li-ion batteries.

The ACCC Report can be found on the ACCC website at: https://www.accc.gov.au/about-us/publications/lithium-ion-batteries-and-consumer-product-safety

The CSIRO report and additional information on Li-ion batteries can be found on the Product Safety website on Li-ion batteries: https://www.productsafety.gov.au/products/electronics-technology/lithium-ion-batteries

What can I do to get assistance?

Market Access can assist you with meeting your regulatory obligations. We can provide customised regulatory training sessions for your company and the specific power tools you import into Australia or New Zealand. We can conduct due diligence and review your available test reports, certificates and information provided to the user such as rating/warning labels and user safety instructions for compliance in order to reduce your risk before the power tools are supplied to the market.

If you would like to discuss how Market Access can assist you with your regulatory requirements, please contact our general enquiries email Gunther Theisz at gtheisz@marketaccessaus.com.au or call our office on +61 2 9099 1557.

 

On October 10, 2023, the TGA announced the start of its medical devices vigilance program pilot. We look at the key aspects of TGA vigilance framework for medical devices and the 12-month voluntary pilot program.

By Val Theisz

Australia has a post-market surveillance framework for therapeutic products. For medical devices, the manufacturers’ post-market responsibilities are specified in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Following the 2020 TGA consultation: ‘Proposed enhancements to adverse event reporting for medical devices‘, the TGA developed the Medical Devices Vigilance Program (MDVP), an initiative aimed at improving sponsors’ understanding of, and compliance with, their post-market obligations through a self-assessment tool (SAT) and program of desktop audits (DAT) and on-site inspections.

The legislative and regulatory provisions reviewed by the MDVP are those defining the conditions for inclusion in the Australian Register Therapeutic Goods (ARTG) and listed below.

Therapeutic Goods Act 1989

• 41FN Conditions applying automatically
• 41KA Public notification, and recall, of medical devices [by the Secretary of the Department of Health]
• 41MP Criminal offence for failing to notify adverse events etc.
• 41MPA Civil penalty for failing to notify adverse events etc.

Therapeutic Goods (Medical Devices) Regulation 2002

• §5.7 Conditions applying automatically – period for giving information about adverse events etc (Act s 41FN)
• §5.8 Conditions applying automatically – requirements in relation to information about kind of medical device (Act s 41FN)
• §5.8A Conditions applying automatically in relation to providing reports about adverse events or occurrences (Act s 41FN)
• §5.10 Conditions applying automatically – record‑keeping (Act s 41FN)
• §5.11 Conditions applying automatically—reporting for Class IIb implantable, Class III, and Class 4IVD medical devices (Act s 41FN)
• §8.1 Notice period for information or documents requested by the Secretary in relation to manufacturing records (5 years) and distribution records (10 years for Class IIb implantable and Class III devices; 5 years for other devices)

The key to compliance is to generate accurate records in a timely manner and maintain those records so that they can be easily retrieved upon request. Documentation and records required include:

• Information substantiating compliance with the essential principles of safety and performance (EPs) and conformity assessment procedures (CAPs)
• Records of complaints and adverse events, including reporting
• Records of recall actions, follow-ups, and notifications
• Product supply and distribution records
• Annual reporting for Class IIb implantable, III and 4 IVD devices

The MDVP Pilot program will run for 12 months, and it represents an excellent opportunity for Australian manufacturers and sponsors to test their existing capabilities and improve their organisations’ compliance with the statutory requirements. Participation is voluntary; all Australian medical device sponsors who have an entry in the ARTG are eligible to participate in the MDVP Pilot.

Details on how to participate in the MDVP Pilot can be found on TGA’s website: Medical Devices Vigilance Program – Pilot

Further information on post-market obligations: Post market responsibilities for manufacturers and sponsors of medical devices

 

Power tools are available everywhere, both to professional tradespeople and laypersons alike. Australian law protects consumers against injury and property damage caused by electrical devices. Before supplying power tools in Australia, importers and distributors need to be aware that there are laws and regulations they must comply with such as electrical and mechanical safety, and electromagnetic compatibility (EMC).

While all electric power tools must be safe before being supplied to the market, many power tools such as portable consumer tools also require mandatory safety certification and equipment Level 3 registration on the Electrical Equipment Safety System (EESS) database. This also applies to any supplied battery chargers for the consumer or DIY market.

In addition, electric power tools must also comply with the Australian Communications and Media Authority’s (ACMA) EMC regulations before marking the tools with the RCM and signing the RCM Supplier’s Declaration of Conformity (SDoC). Some tools may have radiofrequency functions such as Bluetooth, NFC or Wi-Fi, these functions are also regulated by ACMA and supplier declarations must show compliance to radiofrequency (RF) standards.

Tools that include button or coin batteries are subject to safety and information standards mandated by the Australian Competition & Consumer Commission (ACCC) since June 2022.

Failure of importers or responsible suppliers to comply with regulatory requirements and ACCC standards may lead to costly market recalls. The ACCC is proactive and checks compliance with safety standards, performance claims or button/coin mandatory standards. Some typical product failures that can lead to increased risks for consumers and users of power tools are lack of compliance with electrical standards and mechanical guarding of tools, incorrect wiring or earthing, exposed live parts, overheating and risk of fire.

Below link to ACCC’s Product Safety webpage provides useful resources, news and information related to product safety laws and market recalls:

https://www.productsafety.gov.au/

What can I do to get assistance?

Market Access can assist you with meeting your regulatory obligations. We can provide customised regulatory training sessions for your company and the specific power tools you import into Australia or New Zealand. We can conduct due diligence and review your available test reports, certificates and information provided to the user such as rating/warning labels and user safety instructions for compliance in order to reduce your risk before the power tools are supplied to the market.

Market Access AUS Pty Ltd 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 Market Access can assist you with your regulatory requirements, please contact our general enquiries email Gunther Theisz at gtheisz@marketaccessaus.com.au or call our office on +61 2 9099 1557.

NEWSLETTER JULY 2023 – COMPLIANCE AND REGULATIONS 

Market Access Australia news items

Easy links to our latest news items

Variations to the Low Interference Potential Devices (LIPD) Class Licence

These recent changes add a new category for Wi-Fi transmitters using frequencies between 5150 MHz and 5250 MHz, which allows higher power than the existing category, and removes the limitation of the transmitter being classed as indoor use only. Find out more here

 

Vehicle telematics and communications systems

Do your vehicle 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. Find out more here

 

Recent and important product recalls

Button and coin batteries

Products containing button and coin batteries continue to be regularly recalled due to not complying with the ACCC’s mandatory standards. You can find more information on the ACCC requirements at https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards/button-and-coin-batteries

 

Recent recalls

The ACCC Product Safety Australia website lists the current and historical product recalls. https://www.productsafety.gov.au/recalls

 

Recent changes to regulation

ACMA changes

In December 2022, the ACMA made changes to the Telecommunications (Labelling Notice for Customer Equipment and Customer Cabling) Instrument 2015 to give regulatory effect to the Telecommunications (Mobile Equipment Air Interface) Technical Standard 2022. This 2022 standard updated the industry standards to AS/CA S042.1:2022 (general requirements), AS/CA S042.4:2022 (LTE requirements) and AS/CA S042.5:2022 (5G requirements). More details can be found on the ACMA website.

 

In March 2023, the ACMA made changes to the Radiocommunications Equipment (General) Rules 2021 to move regulation of radiocommunications devices into the General Equipment Rules. The mandatory standards for performance are specified in Schedule 5 of the Genera Equipment Rules. More details can be found on the ACMA website.

 

In May 2023, the ACMA updated the Low Interference Potential Devices (LIPD) Class Licence. Find out more information in our news item and find the official variation on the Federal Register of Legislation.

 

Also in May 2023, the ACMA approved a new supplier’s declaration of conformity (form C02). This is the ACMA-approved form for a supplier’s declaration of conformity under the Radiocommunication Equipment (General) Rules 2021 and the Radiocommunications Labelling (Electromagnetic Compatibility) Notice 2017.

Find the form on the ACMA’s website – Form C02: Supplier’s declaration of conformity | ACMA.

 

 

The guide has been designed to be read in conjunction with the Standards, and should not be used as an alternative to the Standards. Button/coin batteries generally operate using one of the 4 chemistries: lithium, alkaline, silver oxide and zinc-air. In industry, the term “coin” is associated with lithium batteries and the term “button” is associated with non-lithium batteries. To read the guide click here.

EU MDR transition provisions affecting ARTG inclusions of non-IVD medical devices – June 2023

Last month, the Australian Therapeutic Goods Administration (TGA) announced that the transition from certification to the old EU Directives for medical devices, including active implantables, to the new EU Medical Devices Regulation (MDR) as basis for inclusion in the ARTG has been extended. This is good news for manufacturers, sponsors, and agents as it buys them more time to obtain CE Marking approvals for their non-IVD medical devices under the EU MDR and use them as basis for inclusion into the Australian Register of Therapeutic Goods (ARTG).

By Val Theisz

In March 2023, the European Commission published its decision to extend the EU MDR transition timelines to allow manufacturers to continue placing their medical devices on the market using their existing certificates issued under the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), and thus avoid shortages of medical devices in EU due to the slower than anticipated transition from the medical device Directives to MDR and IVDR.

Regulation (EU) 2023/607 of 15 March 2023 amending the MDR and IVDR stipulates that the validity of certificates issued under the MDD and AIMDD is to be extended, along with the transitional period during which devices that are in conformity with the MDD and AIMDD can lawfully be placed on the market, from 26 May 2024 to:

• 26 May 2026 for class III custom-made implantable devices
• 31 December 2027 for class III and implantable class IIb devices
• 31 December 2028 for non-implantable class IIb and lower risk devices
• 31 December 2028, for class I devices that are a higher class under the MDR.

Since the 2017 enactment of the EU MDR, the TGA has been updating the Australian medical device regulations to align with the more stringent provisions of the MDR, specifically:

• more stringent requirements to demonstrate medical device safety for patients and users including requirements for clinical evidence
• additional requirements for the manufacturer’s quality management systems
• detailed technical document requirements
• changes to classification rules for medical devices

The great majority of medical devices included in the ARTG rely on having a valid European Certificate of Conformity. A delay in obtaining a certificate under the MDR means that the TGA had to update its own transition timelines to avoid a supply shortage on the Australian market or avoid supplying medical devices in Australia without a valid certificate.

The following MDD certificates that have been extended in the EU, as new or revised Manufacturer Evidence, will now be accepted by the TGA:

• until 26 May 2024, MDD certificates that have not expired, recognising that the expiry date on MDD certificates will not be updated
• until 26 September 2024, MDD certificates that are accompanied by evidence that the manufacturer has applied with a notified body for MDR certification of the device
• after 26 September 2024, MDD certificates that are accompanied by evidence that the manufacturer has a contract with a notified body for MDR certification of the device:
  • until 31 December 2027, for class III and implantable class IIb devices
  • until 31 December 2028, for non-implantable class IIb and lower risk devices.

As the EU removed its 12-month “sell-off” provision, non-transitioning medical devices that comply with the EU MDD may now be supplied in the EU, after May 2025, until the stock is depleted. Hence, the 12-month transition for Australian sponsors to supply devices manufactured before their EU MDD certificate expired, which mirrored the EU “sell-off” deadline, no longer applies.

In addition, the TGA clarified that:

• For new applications that rely on an MDD certificate submitted after the expiry date listed on the certificate, the sponsor will need to provide evidence that the manufacturer is eligible for extended validity under the EU MDR.
• For existing ARTG entries that are supported by EU MDD certificates, certificates that qualify for extended validity in the EU will be considered in-force in Australia and not ‘expired’, despite the expiry date listed on the certificate. MDD certificates will not be considered in-force after 31 December 2028, or after 31 December 2027 for Class III and Class IIb implantable devices. Sponsors will not need to notify the TGA, nor submit a lapse in conformity assessment notification form, where the EU has extended the validity of the MDD certificate. However, they must provide evidence of the extended validity of the certificate if requested.
• Sponsors must notify the TGA within 60 days of any MDD certificate that supports ARTG entries that is no longer valid in the EU, e.g., a certificate that is suspended, cancelled, withdrawn or does not meet the extension requirements in the EU.

The reclassification of certain medical devices in Australia came into effect on 25 November 2021, specifically for:

• active medical devices for therapy with diagnostic function,
• spinal implantable medical devices (motion preserving),
• devices used in direct contact with the heart, central circulatory system, or central nervous system,
• medical devices that administer medicines or biologicals by inhalation, and
• medical devices that are substances introduced into the body via body orifice or applied to the skin.

New applications for ARTG inclusion must be lodged at the higher classification.

Sponsors of existing ARTG entries who notified the TGA before 25 May 2022, must apply for their device to be included in the ARTG at the higher classification before 1 November 2024, failing which their ARTG entries at the lower classification will be cancelled.

The TGA stated on its website that “is considering the impact of the EU MDR transition extension on Australia’s reclassification and personalised medical device reforms and will provide advice to the Government about whether changes to the transition timeframes will be needed”.

Further details are available on TGA’s dedicated webpage EU MDR Transition.

 

Do your products have Wi-Fi capability?

 

If yes, you might be interested in a recent variation the Australian Communications and Media Authority (ACMA) has made to the Radiocommunications (Low Interference Potential Devices) Class Licence.

 

All radio transmitters are required to be licensed in Australia. Wi-Fi transmitters are licensed through the Radiocommunications (Low Interference Potential Devices) Class Licence, also known as the LIPD Class Licence. The class licence specifies the frequency and maximum power that transmitters are allowed to use and can also include additional restrictions.

 

What are the changes?

These recent changes add a new category for Wi-Fi transmitters using frequencies between 5150 MHz and 5250 MHz, which allows higher power than the existing category, and removes the limitation of the transmitter being classed as indoor use only. However, it does include a restriction to limit the chance of interference to satellite communications.

 

Another change is that a definition of indoors has been added. This is important because several categories for Wi-Fi transmitters are authorised for indoor use only.

 

All the changes in the recent variation can be found at Federal Register of Legislation

 

What can I do to get assistance?

Market Access can assist you with meeting your obligations.

 

Market Access AUS Pty Ltd 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 Market Access can assist you with your regulatory requirements, please contact our general enquiries email Gunther Theisz at gtheisz@marketaccessaus.com.au or call our office on +61 2 9099 1557.

Australian regulatory requirements for clinical decision support software (CDSS) – May 2023

Clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods (ARTG) unless otherwise exempt. CDSS that does not meet the definition of a medical device, or is excluded, is not subject to regulation by the TGA. The latest regulatory guidelines provide explanations to the new classification rules and examples of exempt CDSS.

By Val Theisz

 

In August 2022, the Australian Therapeutic Goods Administration (TGA) published a new guidance on exemption criteria for certain clinical decision support software or CDSS. This guidance further clarifies TGA’s position on software used in healthcare facilities, after the 2021 amendments to medical device regulations which introduced new requirements for software-based medical devices, including:

• clarifying the boundary of regulated software products (including ‘carve outs’)
• introducing new classification rules
• providing updates to the essential principles relevant to software-based medical devices.

In past years, during meetings with industry, it was apparent that some health software developers were not clear weather their products such as healthcare software used in clinics and hospitals were affected by regulatory requirements for software as medical device (SaMD). There had even been alarmist calls that the regulatory amendments would result in previously unregulated or class I software products being regulated as high-risk class III products. None of those fears materialized.

In 2021, the TGA published a guideline with explanations and examples that clarify the boundary for software-based products – which products are regulated as medical devices and which are exempt or excluded (or ‘carved out’ of the regulation), to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight.

The distinction between “exempt” and “excluded” is important, as is checking whether the intended purpose of a software product meets the definition of a medical device.

• “Excluded” means that the software products are completely unregulated by TGA because they do not fall under the definition of a medical device (provided in Section 41BD of the Therapeutic Goods Act 1989).

Examples of excluded software-based products include consumer health apps (wellness, self-management of non-serious condition, behavioral change, patient surveys); enabling technology (telehealth consultation enabling software, software for management of health processes or facilities, transmission and storage of imaging records); digitization software (simple calculators of clinical outputs, electronic patient/health records); population based analytics for the collection and analysis of class, group or population data that are not intended to be used for clinical use cases for individuals; and laboratory information management systems that allow laboratories to automate workflows, integrate instruments, manage orders and samples and associated information.

• “Exempted” means that TGA retains some regulatory oversight (advertising, adverse events, notification), but they are not required to be approved by the TGA prior to supply, and do not need to be included on the Australian Register of Therapeutic Goods (ARTG).

Examples of exempted software-based products include certain CDSS such as software intended to compare patient symptoms and test results with available clinical practice guidelines and recommend condition-specific diagnostic tests, investigations or therapy to a health practitioner; surgical workflow software that describes the steps of a surgical procedure to a surgeon based on accepted clinical guidelines.

The previous TGA guidance on CDSS (October 2021) stated that a CCDS is exempt if it meets all three of the following criteria:

• does NOT directly process or analyse a medical image or a signal from another medical device (including an in vitro diagnostic device); and
• is solely used to provide or support a recommendation to a health professional about prevention, diagnosis, curing or alleviating a disease, ailment, defect, or injury; and
• does NOT replace the clinical judgement of a health professional in relation to making a clinical diagnosis or decision about the treatment of patients.

If any of these criteria are not met, the CDSS is not exempt and requires inclusion in the ARTG.

 

The latest 2022 TGA guidance on CCDS (August 2022) includes useful real-life examples, and provides additional comprehensive information for the exemption criteria. According to these latest guidelines, a CDSS is exempt only is it meets all three exemption criteria set out in the table and reproduced here:

1. Intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a health professional about preventing, diagnosing, curing, or alleviating a disease, ailment, defect, or injury in persons
2. Not intended by its manufacturer to directly process or analyse a medical image or a signal from another medical device (including an in vitro diagnostic medical device)
3. Not intended by its manufacturer to replace the clinical judgement of a health professional in relation to making a clinical diagnosis or decision about the treatment of patients.

 

An additional table provide clarification on the distinction between:

• Making a diagnosis vs. making a recommendation about diagnosis; and
• Specifying treatment vs. making a recommendation about treatment
• The following legal requirements apply to exempt CDSS:
• Sponsors must notify the TGA of their exempt CDSS devices. You must notify the TGA using the Notification form: Clinical Decision Support Software Exemption within 30 working days of supply. Following notification to the TGA, you are able to supply the device if you believe it to be exempt.
• Sponsors of exempt software must ensure it meets the relevant essential principles for safety and performance of medical devices. The essential principles describe the fundamental design and manufacturing legislative requirements. More information on the essential principles can be found in the Manufacture of medical devices: Quality management | Therapeutic Goods Administration (TGA).
• The TGA can take regulatory action such as a recall or issuing a hazard alert if there is a problem with the device.
• Sponsors must report adverse events to the TGA.
• Sponsors must comply with the advertising requirements for therapeutic goods

The regulation of software-based products and addressing borderline issues between medical devices and non-medical devices has come a long way since early consultations between industry and the TGA. TGA has committed to continue reviewing exemption notifications periodically to ensure they are being applied correctly.

 

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