medical devices

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MD Regulatory transition under Brexit

With the UK having exited the EU in February 2020 (Brexit), manufacturers of medical devices and IVDs need to ensure they have plans in place to comply with the UK...
Pile of Documents

DOC’s will need to be submitted for new Class I IVD ARTG registrations

Similarly, to TGA’s recent notification on 1 October 2020, the TGA has issued a notice of upcoming changes for Class IVD registrations via an email to stakeholders on 17 November...
Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes, including: new classification rules for...
Taipei, Taiwan

Upcoming update to the Taiwan FDA Medical Devices Act

Taiwan has one of the most enviable healthcare systems in the world - it boasts the number one ranking among 93 countries two years in a row from mid-2018 and...
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TGA deploys Post Market Review Compliance Dashboard

Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to...
Time Lapse

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their Conformity Assessment Documents in response...
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TGA will require DOC’s to be submitted for Class I ARTG registrations

Australia’s, Therapeutic Goods Administration (TGA) issued a notice on 1 October 2020, in addition to an email to stakeholders prior, specifying new policies for the inclusion of non-sterile, non-measuring Class...
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What you need to know about disinfectants in Australia

In May 2020, we looked at hand sanitisers and TGA’s exemption on certain formations in response to the COVID-19 emergency. As we are seeing an increasing number of corporations receiving...
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TGA published review of safety and performance issues in Medical Device software

Software as a Medical Device (SaMD) In recent years software usage has become ubiquitous and software resources, particularly mobile apps accessible through smartphones, have increased in complexity and usage. The...
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Harmonised Standards for MDR? CEN/CENELEC say “Non”

Back in November 2019, looking at the virtual break down in harmonisation of standards to the European Directives and the belated request from the Commission for harmonisation to MDR of...

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