Software as a Medical Device (SaMD) Archives

Transition Plan and Regulatory Changes for Software as Medical Devices

By Mohammad Asad | 18 February 2021

In our November 2020 blog post, we communicated the changes regarding the implementation dates and the criteria for Software as a Medical Device regulations as amended in the Therapeutic Goods...

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...

Software as a Medical Device – Upcoming Changes to the Australian Regulations

By Belinda Dowsett | 29 May 2020

With advancements in software and medical device technology extending beyond the current scope of the Therapeutic Goods Regulations, new legislation is due to take effect in August 2020. Since the...

Article: EU Software Classification under MDR/IVDR – New Guidance Documen

EU Software Classification under MDR/IVDR – New Guidance Document

By Yervant Chijian | 28 October 2019

In October 2019 the Medical Device Coordination Group (MDCG) released a new guidance document on Qualification and Classification of Software in the European Regulations 2017/745 – MDR and 2017/746 –...