Gong Xi Fa Cai. Wishing all our customers and friends a Happy Chinese New Year. We hope that 2021 will keep you safe and healthy.
Evidence requirements for face masks that are medical devices.
If you are considering supplying face masks (including respirators) that meet the definition of a medical device in Australia, you will need to apply for the inclusion of these products in the Australian Register of Therapeutic Goods (ARTG).
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.”
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:
Our office telephone is set to divert to Gunther’s mobile during the current crisis. However, you can phone his mobile direct +61 435 814 455.
Alternatively, you can email us at http://email@example.com
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.
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
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.
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.
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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