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