Homi Dalal

Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

By Homi Dalal | 19 November 2020
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...
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TGA deploys Post Market Review Compliance Dashboard

By Homi Dalal | 29 October 2020
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...
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TGA published review of safety and performance issues in Medical Device software

By Homi Dalal | 29 July 2020
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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Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019.

By Homi Dalal | 22 July 2020
The definitive risk management standard for medical devices - ISO 14971: 2019 - Medical Devices – Application of Risk Management and the accompanying guidance on its application - ISO TR...

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Recent Posts

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

Nov 26, 2020

Formulated ingredients and premixes: Keeping the IP of a PI

Nov 24, 2020

TGA guidance for SaMD Regulatory “Carve Out”

Nov 19, 2020

Upcoming update to the Taiwan FDA Medical Devices Act

Nov 2, 2020

TGA deploys Post Market Review Compliance Dashboard

Oct 29, 2020

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

Oct 19, 2020

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