BE REWARDED FOR PLAYING BY THE RULES
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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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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03 Dec

Button batteries to receive new guidance

Leaders from the consumer, services and product industry came together at Standards Australia recently to agree on the development of a button battery standard.

This decision follows an increase of concerned communities as the use of button batteries continues to rise in Australia. Known for being in children’s toys, button batteries can now be found in a much wider range of consumer products and are also sold as a standalone product.

“The outcome of this forum of members of the public, industry bodies and regulators including the Australian Consumer and Competition Commission (ACCC), confirmed concerns around button batteries and the need to provide further guidance to address button batteries issues in a measured approach,” said Head of Stakeholder Engagement Daniel Chidgey.

“While there are some standards that reference these batteries, there is not yet any holistic guidelines for products with button batteries,” said Mr Chidgey.

“Button batteries can be found in a range of items including thermometers, remote controls, children’s toys and novelty items,” said Ms Barbara Geens, Chair of the Industry Working Group on Button Batteries Safety. “The goal of this proposed standard is to create a unified approach for safer use and distribution of these batteries which is an essential step in protecting consumers.”

“This is an example of Standards Australia proactively working with industry, government and the public to provide the right standards solutions to equip the consumer products, services and safety sector. We look forward to continuing to work with industry and the Australian community in developing this pivotal guidance,” concluded Mr. Chidgey.

Read more at: Standards Australia

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02 Dec

The number of product recalls in Australia has tripled over the last twenty years.

The number of product recalls in Australia has tripled over the last twenty years. That means millions of unsafe products that should have been stopped before they made it to stores, are now in our homes. 

We need laws that require businesses to proactively check that products are safe before selling them. It shouldn’t be up to us to discover a product is unsafe after we’ve bought it. That’s why we’ve made a submission to the Government calling for stronger product safety laws and to stop Australia becoming a dumping ground for dangerous products.

We’re trying to spread the news far and wide that our current product safety system is failing us and that we need urgent action. 

Not on social media? Why not email this link to our petition to a friend instead: choice.com.au/productsafety

The growing number of recalls that happen each week means that it’s impossible for most people to keep track, so many of us might have dangerous products in our homes and not even know about it. Over sixty products have been recalled so far this month alone. 

Something has to change in our product safety system to stop people being harmed from unsafe products. We’re fighting for a general safety provision to stop further tragedies caused by unsafe products. After sustained pressure from thousands of people like you, the Government is now seriously considering it. 

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30 Sep

After 1 October 2019, Qld RECS external certifiers shall only upload Qld RECS certificates to the national database

Recognition of certifications in Victoria

Certificates issued by external certifiers recognised by a declared jurisdiction are recognised in Victoria. Currently this means that certificates issued by certifiers under the Queensland Recognised External Certification Schemes (RECS) are recognised in Victoria.

ESV will administratively recognise certificates issued by Australian regulators who have not yet enacted corresponding law provided their certificate data is uploaded to the national certification database.

From 1 April 2019 to 1 October 2019 private certifiers can continue to upload REAS certificate data to the national certification database. This is not a recognition of REAS certificates but part of a temporary transitional allowance to assist industry with moving to compliance  with Victorian law.

ESV will work with private certifiers and the Queensland Electrical Safety Office (QLD) to assist private certifiers who have made an application to become a RECS with QLD, and provided that there is no obvious concern or issue raised by QLD, ESV will not prohibit the certifier from continuing to upload REAS certificates after 1 October 2019. This will only apply if the certifier gives ESV an undertaking to only issue certification in accordance with EESS and RECS requirements, this includes compliance to the Equipment Safety Rules. This is not a recognition of the certifier but a temporary transitional allowance to assist the external certifier and industry. This temporary transition allowance will cease on 1 April 2020.

  • After 1 October 2019, QLD RECS external certifiers shall only upload QLD RECS certificates to the national database.
  • After 1 October 2019 and up to 1 April 2020, NSW REAS private certifiers who have made an application to become QLD RECS, but have not yet finalised the process, may have additional temporary transitional arrangements apply for uploading REAS certificates that comply with the Equipment Safety Rules.
  • After 1 October 2019, NSW REAS private certifiers who have not made application to become a QLD RECS cannot upload any new certificates onto the EESS database.

The temporary transitional arrangements allow for a total of a 12-month period of transition for industry to ensure they have correct certificates on the EESS database to register their equipment on the EESS.

Read more here

 

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06 May

Implementation of EESS in Victoria 1 April 2019. We can issue safety certificates under the RECS scheme.

Implementation of EESS in Victoria
The requirements were implemented 1 April 2019.
Introduced to improve consumer safety for household electrical equipment sold in Victoria, the EESS aims to harmonise various state legislation across Australia and provide the public with a national database of responsible suppliers and electrical equipment registrations.

 

Recognition of certification in Victoria
Certificates issued by external certifiers recognised by a declared jurisdiction are recognised in Victoria. Currently this means that certificates issued by certifiers under the Queensland Recognised External Certification Schemes (RECS) are recognised in Victoria.ESV will administratively recognise certificates issued by Australian regulators who have not yet enacted corresponding law provided their certificate data is uploaded to the national certification database.From 1 April 2019 to 1 October 2019 private certifiers can continue to upload REAS certificate data to the national certification database. This is not a recognition of REAS certificates but part of a temporary transitional allowance to assist industry with moving to compliance with Victorian law.ESV will work with private certifiers and the Queensland Electrical Safety Office (QLD) to assist private certifiers who have made an application to become a RECS with QLD, and provided that there is no obvious concern or issue raised by QLD, ESV will not prohibit the certifier from continuing to upload REAS certificates after 1 October 2019. This will only apply if the certifier gives ESV an undertaking to only issue certification in accordance with EESS and RECS requirements, this includes compliance to the Equipment Safety Rules. This is not a recognition of the certifier but a temporary transitional allowance to assist the external certifier and industry. This temporary transition allowance will cease on 1 April 2020.

  • After 1 October 2019, QLD RECS external certifiers shall only upload QLD RECS certificates to the national database.
  • After 1 October 2019 and up to 1 April 2020 NSW REAS private certifiers who have made an application to become QLD RECS, but have not yet finalised the process, may have additional temporary transitional arrangements apply for uploading REAS certificates that comply with the Equipment Safety Rules.
  • After 1 October 2019 NSW REAS private certifiers who have not made application to become a QLD RECS cannot upload any new certificates onto the EESS database.

The temporary transitional arrangements allow for a total of a 12-month period of transition for industry to ensure they have correct certificates on the EESS database to register their equipment on the EESS.

There is no prohibition against an NSW REAS private certifier applying for recognition under Queensland legislation and becoming a RECS.

Any external certifier that is not accredited or is not in the process of obtaining accreditation under the Queensland legislation by 1 October 2019 will have restricted access to the national certification database and will not be authorised to upload new certificates.

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13 Mar

Button battery safety failures. CHOICE test labs find plenty of safety risks in everyday household items.

Industry ignores voluntary guidelines


  • 10 out 17 common household products failed our button battery safety test.
  • Despite two deaths and many injuries to children, product makers are largely ignoring the voluntary button battery safety code.

Button batteries are everywhere these days, powering everything from medical devices to musical birthday cards.

But there’s a price to pay for the convenience: button batteries have long been a potentially lethal threat to young children, who ingest them at an alarming rate.

Read more here.

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05 Nov

EESS fees – From 1 January 2019 renewal fees will apply for all Level 2 and Level 3 registered in-scope electrical equipment.

Since the EESS commenced in Queensland in 2013, responsible suppliers have not been required to pay renewal fees for registration of in-scope electrical equipment. EESS fees have also not been subject to CPI increases. These “exemptions” were put in place until other States and Territories adopted the EESS.

Western Australia and Victoria have now signed on to the EESS and Victoria recently passed legislation to enact the EESS as law. As a result, from 1 January 2019 renewal fees will apply to all level 2 and 3 registered in-scope electrical equipment, and will also be subject to CPI increases.

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11 Sep

4.5 million recalls in FY18. Faulty products continue to cause serious injury and harm to thousands of Australians.

Faulty products hit list

4.5 million recalls in FY18.

Faulty products continue to cause serious injury and harm to thousands of Australians, with more than 4.5 million items recalled by suppliers in the 2017-18 financial year. A total of 613 products were recalled, 26 from the electronics and technology sectors.

New figures showed at least 10 people a day are injured and require medical attention as a result of unsafe products, according to mandatory reports provided to the ACCC by manufacturers and retailers.

“Ten injuries a day due to defective products is alarming, but we suspect this is just the tip of the iceberg as many more consumers don’t report injuries to the product suppliers at all,” ACCC deputy chair Delia Rickard said.

Read more of the Appliance Retailer article here.

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