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...
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...
Software as a Medical Device – Upcoming Changes to the Australian Regulations
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...
EU Software Classification under MDR/IVDR – New Guidance Document
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 –...
