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06 Oct

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

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 four labelling notices 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.

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 (Compliance Labelling – Devices) Notice 2014 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 (Compliance Labelling – Electromagnetic Radiation) Notice 2014 and the Radiocommunications (Electromagnetic Radiation – Human Exposure) Standard 2014 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?

Certification Body Australia can assist you with meeting your obligations.

Certification Body Australia (CBA) 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.

We are also a JAS-ANZ accredited Certification Body under the ACMA’s Telecommunications Equipment Certification Scheme (TECS). CBA performs assessments for compliance with applicable ACMA requirements and issues Statements of Compliance for telecom devices (3G/4G/5G, mobile phones or modules).

If you would like to discuss how CBA can assist you with your regulatory requirements, please contact Colin Payne (cpayne@certificationbody.com.au) or use our general enquiries email: contact@certificationbody.com.au.

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

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29 Sep

CBA launches its permanent consulting service for MedTech companies requiring regulatory and quality management systems support.

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, Certification Body Australia 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

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18 May
17 May

Button & coin batteries – Four mandatory standards have been published since December 2020 to reduce the risk of death and injury.

Information supplied by ACCC.

Four mandatory standards have been introduced to reduce the risk of death and injury associated with the use of button and coin batteries. The requirements of the mandatory standards are applicable to both button cell and coin cell batteries.

About button/coin batteries

Button/coin batteries are flat, round single cell batteries with a diameter of up to 32 mm that range in height from 1–11 mm.

In Australia and globally, there is a growing record of serious injuries and deaths of children from these batteries. In Australia, three children have tragically died as a result of swallowing a coin battery and there is an increasing number of young children suffering severe injuries following the ingestion or insertion of button batteries.

Button/coin batteries generally operate using one of four chemistries: lithium, alkaline, silver oxide and zinc air. Lithium or coin batteries pose the highest risk. Their typically larger diameter means they are more likely to become stuck in a child’s oesophagus if ingested and their higher voltage means they can cause tissue damage more quickly.

Products containing button/coin batteries include but are not limited to:

  • remote controls
  • watches
  • computers
  • cameras
  • calculators
  • torches
  • flameless candles
  • fitness devices
  • digital kitchen and bathroom scales
  • musical greeting cards
  • home medical devices.

Button/coin battery mandatory standards

The four mandatory standards are:

The mandatory standards include an 18 month transition period to allow suppliers time to implement any manufacturing and design changes to products and packaging to comply with the new requirements. From June 2022 suppliers must comply with the requirements in the standards.

The requirements listed below with each mandatory standard aim to give suppliers a general idea of what is required by that standard. Suppliers must not rely on this information as a complete guide to compliance.

Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard

This mandatory standard prescribes requirements for all consumer goods containing button/coin batteries, including storage containers and organisers, and accessories of consumer goods, such as remote controls that contain button/coin batteries.

This mandatory standard requires consumer goods containing button/coin batteries to have secure battery compartments, where the batteries are intended to be replaced, and to be subjected to compliance testing. Compliance testing applies whether or not the batteries are intended to be replaced, in order to demonstrate the battery is secure and not released during reasonably foreseeable use or misuse conditions.

This mandatory standard refers to national and international industry standards, which are available from SAI Global and UL Standards.

You must consult this mandatory standard for these details.

Key requirements

Design and construction

A secure battery compartment is the most crucial safeguard to improve safety by preventing children from accessing button/coin batteries. To ensure an acceptable level of safety, consumer goods containing button/coin batteries are to be subjected to secure battery requirements and compliance testing. This is aimed at ensuring that:

  • consumer goods containing button/coin batteries that are intended to be replaced by the consumer have a secure battery compartment that is resistant to being opened by young children
  • consumer goods containing button/coin batteries, whether or not the batteries are intended to be replaced, are secure and do not release the batteries during reasonably foreseeable use or misuse conditions.

Testing methods

To demonstrate compliance with the requirements of this safety standard, suppliers of consumer goods that contain button/coin batteries may choose to comply with the set of compliance tests that are referenced in either:

  • one of the product-specific industry standards — that is, industry standards that apply vertically to a specific product category, or
  • a non-product specific industry standard — that is, an industry standard that applies horizontally to products that contain button/coin batteries.

On request by a regulator, a supplier must nominate the set of compliance tests that the supplier has relied upon to demonstrate compliance with this safety standard.

Exemptions

This mandatory standard does not apply to:

  • hearing aids
  • consumer goods that were first supplied to a consumer before the requirements became mandatory
  • professional equipment where all of the following apply:
    • the equipment is intended to be used in trades, professions or industries
    • the equipment is not intended for sale to the general public
    • the equipment is not intended to be used where children are present
  • audio-visual and information and communications technology equipment containing button/coin batteries that are soldered in place.

Consumer Goods (Products Containing Button/Coin Batteries) Information Standard

This mandatory standard prescribes warning requirements and best practice recommendations for consumer goods containing button/coin batteries, including storage containers and organisers, and accessories of consumer goods, such as remote controls that contain button/coin batteries.

This mandatory standard requires consumer goods containing button/coin batteries to provide warnings and information about the battery hazard on product packaging and in the instructions for use. Warnings are necessary when supplying consumer goods containing button/coin batteries to alert consumers to the battery hazard and to provide relevant information so that appropriate action can be taken when it is suspected that a child has swallowed or inserted a button or coin battery.

This mandatory standard refers to national and international industry standards which are available from SAI Global and the International Organization for Standardization.

You must consult this mandatory standard for these details.

Key requirements

Marking

This information standard requires:

  • consumer goods containing button/coin batteries to include a warning in the accompanying instructions
  • packaged consumer goods containing button/coin batteries to be marked clearly with a warning (at a minimum, symbol warnings are to be provided on the front panel of the packaging)
  • consumer goods with accompanying instructions to include a warning about the button/coin battery that is clearly visible, prominent and legible
  • packaged consumer goods containing button/coin batteries that are not accompanied by instructions to have a warning attached to, or included with, the consumer good
  • unpackaged consumer goods containing button/coin batteries to have a warning attached to the consumer good, such as by applying a swing tag or sticker to the unpackaged product.

Some categories of consumer goods that contain button/coin batteries pose a lower risk in terms of battery accessibility and more flexible warning requirements apply that require, at a minimum, that warnings are provided in accompanying instructions.

This information standard also provides a range of best practice recommendations to provide flexibility in the application of warnings.

This information standard includes the following example of an internationally recognised safety alert symbol that can be included in warnings (not to scale):

Internationally recognised safety alert symbol

Exemptions

This mandatory standard does not apply to:

  • consumer goods that were first supplied to a consumer before the requirements became mandatory
  • professional equipment where all of the following apply:
    • the equipment is intended to be used in trades, professions or industries
    • the equipment is not intended for sale to the general public
    • the equipment is not intended to be used where children are present
  • audio-visual and information and communications technology equipment containing button/coin batteries that are soldered in place.

Consumer Goods (Button/Coin Batteries) Safety Standard

This mandatory standard prescribes requirements for child-resistant packaging when supplying button/coin batteries, based on their risk profile, to reduce the risk of death or serious injury to children as a result of accessing batteries directly from packaging.

This mandatory standard refers to national and international industry standards, which are available from SAI Global and the International Organization for Standardization.

You must consult this mandatory standard for these details.

Key requirements

Design and construction

Child-resistant packaging is used to create a physical barrier between a child and a potentially hazardous product. It is designed in a way that limits the ability for a child to access the hazardous good but is not necessarily child-proof.

Blister packaging is the standard form of packaging for button/coin batteries at present. This safety standard does not specify any particular form of packaging or container that must be used when supplying button/coin batteries, only that the packaging or container must be child-resistant in accordance with specified compliance tests.

Testing methods

This safety standard includes reference to compliance tests in industry standards and overseas regulations that must be performed on packaging or containers to demonstrate the child-resistant packaging requirement has been met. On request by a regulator, a supplier must nominate the set of compliance tests that the supplier has relied upon to demonstrate compliance with this safety standard.

Exemptions

This mandatory standard does not apply to:

  • zinc-air button batteries intended for hearing aids
  • button/coin batteries supplied in bulk intended to be used in trades, professions or industries and which are not intended for sale to the general public.

Consumer Goods (Button/Coin Batteries) Information Standard

This mandatory standard prescribes warning requirements and best practice recommendations for button/coin battery packaging and button/coin batteries themselves. Button/coin battery packaging refers to all types of packaging or containers used when supplying button/coin batteries.

This mandatory standard requires button/coin battery packaging to be marked clearly with warnings and information about the battery hazard. Warnings are necessary when supplying button/coin batteries to alert consumers to the hazard and to provide relevant information so that appropriate action can be taken when it is suspected that a child has swallowed or inserted a button or coin battery.

This mandatory standard refers to national and international industry standards, which are available from SAI Global and the International Organization for Standardization.

You must consult this mandatory standard for these details.

Key requirements

Marking

This information standard requires:

  • packaging used to supply button/coin batteries to be marked clearly with a warning
  • button/coin batteries with a diameter of 20 mm or more to be marked with a ‘keep out of reach of children’ symbol on the battery cell.

The information standard also provides a range of best practice recommendations to provide flexibility in the application of warnings.

This information standard includes the following examples of internationally recognised symbols that can be included in warnings (not to scale):

Keep out of reach of children
Keep out of reach of children symbol
Safety alert
Safety alert symbol

Exemptions

This mandatory standard does not apply to button/coin batteries supplied in bulk intended to be used in trades, professions or industries and which are not intended for sale to the general public.

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11 May

Medical devices – does your medical device connect to a telecommunications network? Does your device use Bluetooth or Wi-Fi? Read more.

Medical devices

Does your medical device connect to a telecommunications network?

Does your device have radio transmitters (such as Bluetooth or Wi-Fi)?

This information may be of interest to you.

More requirements than medical safety and EMC

In Australia, in addition to electromedical safety and EMC requirements, there are regulations that apply to equipment that can connect to a telecommunications network, equipment that incorporates one or more radiocommunications transmitters, and requirements to prevent equipment from causing radio interference. Many of these requirements may also apply to medical devices depending on the features of your device.

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 four labelling notices by the ACMA which have requirements for equipment. It is possible that all four labelling notices could apply to the same equipment.

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

But do these apply to medical devices?

If your medical device is required to comply with EMC requirements as part of regulation by the Therapeutic Goods Administration (TGA) then your device may be exempt from the EMC labelling notice.

However, there are no medical device exemptions in the other labelling notices. If you have Bluetooth or Wi-Fi, or another radio transmitter there may be requirements in the radio labelling notice and the EME labelling notice.

If your device can connect to a telecommunications network, such as 3G or 4G mobile networks, there may be requirements in the telecommunications labelling notice.

What can I do to get assistance?

Certification Body Australia can assist you with meeting your obligations.

Certification Body Australia (CBA) 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 CBA can assist you with your regulatory requirements, please contact Colin Payne (cpayne@certificationbody.com.au) or contact@certificationbody.com.au.

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10 Mar

Radiocommunications Modernisation Act. 10 March 2021- The ACMA has today published an information paper and 3 consultations in relation to reforms that will modernise the legislative framework for spectrum management.

The proposed changes to licensing and allocation arrangements have been driven by the Radiocommunications Legislation Amendment (Reform and Modernisation) Act 2020, which received Royal Assent on 17 December 2020. This will allow the ACMA to update the Radiocommunications Act 1992. In the information paper, we describe our broader approach to selecting spectrum, apparatus and class licensing for different use scenarios. We discuss how the amendments can provide increased flexibility in selecting apparatus or spectrum licensing for some use cases. The provisions of the acts will come into force on 17 June 2021, giving users of spectrum time to adjust to the new regulatory framework. We are also seeking your views on the consultations below.  Radiocommunications equipment rules We are consulting on draft Radiocommunications Equipment (General) Rules 2021. The proposed new equipment rules are designed to ensure that all of the existing requirements remain enforceable. Changes to class licences  We are proposing to amend the relevant class licences to include references to equipment rules, and are also taking the opportunity to consult on our proposal to harmonise how our electromagnetic (EME) regulatory framework applies EME emission limits to class-licensed radiocommunications transmitters. Accredited persons scheme The accredited persons scheme (AP scheme) was created to make spectrum management more efficient by allowing  accredited persons to perform specific activities such as technical assessment, coordination and assignment. Because of recent changes with the above acts, we need to make legislative instruments to preserve the AP scheme.
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