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08 Jun

FREE Q&A session: Learn all about **Requirements for SaMD and AI/ML in medical devices** in this new JMDR medical device expert podcast episode 🎤 🎧, featuring our Editorial Board member Val Theisz from Market Access Australia.

Val answers questions posed by JMDR subscribers on the regulatory requirements for SaMD and AI/ML in medical devices. The slides she uses are also available for free download alongside the audio and video files.

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23 Mar

ACCC have published a Guide for business on the application of mandatory standards for button/coin batteries. The standards are mandatory from 22 June 2022.

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.

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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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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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17 Sep

GMDN free membership since April 1st 2019. The free GMDN membership allows search of GMDN Codes and provides enquiry services .

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 1st 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.”

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09 Sep

Product Approval Marking for NSW – From 1 July 2020 the marking of appliances for sale in NSW must have the the approval number for declared articles (Level 3) when certified by a private certifier under the REAS Scheme.

From 1 July 2020 the marking of appliances for sale in NSW must have the the approval number for declared articles (Level 3) when certified by a private certifier under the REAS Scheme. For certificates issued by Certification Body Australia the product must be marked with CBA-xxxxxx-EA as well as the RCM.

More information is available on the link below:

https://www.fairtrading.nsw.gov.au/buying-products-and-services/product-and-service-safety/electrical-safety/safety-labels-for-electrical-goods

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24 Mar
22 Mar

Please read our COVID-19 Response Plan. We are fully equipped to work remotely. Stay safe and well.

To all our customers, we hope that you remain well and healthy during this unprecedented time.

We would like to re-assure you that we are well equipped to work remotely and to continue to service our customers with the same level of professionalism and quality that we have always provided.

For urgent matters Gunther can be contacted on his mobile 0435 814 455.

Read our COVID-19 Response Plan here.

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