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Val Theisz, our regulatory and quality consultant for medical devices, was one of the presenters at the RAPS 2021 Euro Convergence conference held between 10 – 12 May. Val presented on the latest developments in medical device regulations in Australia including tips for overcoming challenges for exporters to the Australian market.
Button & coin batteries – Four mandatory standards have been published since December 2020 to reduce the risk of death and injury.
Medical devices – does your medical device connect to a telecommunications network? Does your device use Bluetooth or Wi-Fi? Read more.
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.
GMDN free membership since April 1st 2019. The free GMDN membership allows search of GMDN Codes and provides enquiry services .
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"Accredited test reports and certificates (to show compliance)…………………………"
"Instruction manuals, rating labels, warnings (English language only)…………………"
"Colour photographs, certification for critical components ……………………"
"Agent’s authorisation (if applicable)………………………………………."
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