Thousands of unapproved USB phone chargers seized by NSW Fair Trading
Thousands of counterfeit USB phone chargers displaying fake approval numbers have been seized in raids conducted by NSW Fair Trading across Sydney.
Read more: SMH 14 April 2016
14
Apr
06
Apr
“Not everyone reads the booklet” – Mother’s safety plea at inquest into death of toddler crushed by TV
Mother’s safety plea at inquest into death of toddler crushed by TV
Read more : ABC News
06
Apr
Interim Ban on Hoverboards – they may cause injury to persons because of the risk of fire and overheating while charging.
Consumer Product Safety Response to Hoverboard Fires
The Minister for Small Business and Assistant Treasurer, the Hon Kelly O’Dwyer MP, has imposed an interim ban on the sale of hoverboards that do not meet the safety standards specified in the ban.
17
Mar
Electrical cable could become fire risk in Australian homes within weeks, ACCC warns.
Posted
Dangerous electrical cabling installed in homes across Australia could become a fire and electrocution risk within weeks, according to the consumer watchdog.
About 2,300 kilometres of Infinity and Olsent-branded cable remain in hundreds of homes in every state except the Northern Territory.
The cable was recalled after testing revealed its polymer casing was poor quality, causing it to become brittle rapidly in areas of high heat such as around light fittings and ovens.
Australian Competition and Consumer Commission (ACCC) deputy chair Delia Rickard said the cable was first installed in homes in New South Wales in 2010.
Read more: ABC News
19
Feb
EESS REGULATORY MARKING REQUIREMENTS FOR IN-SCOPE PLUG AND CORD OR CORDSET
1. Plug and cord sold with other equipment
i)The in-scope electrical equipment (“the equipment’) the plug and cord is supplied with will need to be marked with the RCM.
ii) the equipment will need to be registered to the responsible supplier on the EESS database according to the equipment risk level.
iii) The plug and cord may be marked with the RCM, but not if they will need to have the certification marking aligning with the certificate issued for that component, and have markings of the brand and model identifiable for each component.
iv) A cord marked in accordance with the CENELEC HAR marking scheme is acceptable and in that situation does not require the RCM.
15
Feb
Medical Safety – New Standards Published
The following standards have now been published:-
- AS/NZS IEC 60601.2.2
- AS/NZS IEC 60601.2.45:2015
- AS/NZS IEC 60601.2.27
15
Feb
ACMA Compliance and Labelling from 1 March 2016 – Supplier Update
Single compliance mark—end of transition period approaching!
The single Regulatory Compliance Mark (RCM) was introduced on 1 March 2013 with a three-year transition period to 29 February 2016.
Suppliers must register on the online national database and start using the RCM by 1 March 2016.
12
Feb
The ACMA requires the supplier to sign a Declaration of Conformity (DoC) before labelling the product with the RCM
The final step to product compliance involves labelling the product:
Steps to compliance
1. Identify the applicable labelling notice
2. Identify the applicable technical standards (prescribed in the relevant labelling notice) and the testing requirements
3. Demonstrate product compliance
4. Complete a Declaration of Conformity (DoC) and maintain compliance records
5. Register as a ‘responsible supplier’
6. Label the product
The ACMA regulatory arrangements require a supplier to apply a compliance label to a product before the product is supplied to the Australian market.
31
Aug
Medical Device Regulatory Practices – An International Perspective, by Val Theisz
This book is intended to serve as a reference for professionals in the medical device industry, in particular those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated and the bar is raised constantly as patients and consumers expect the best quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success.
Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.