A joint initiative between ANDHealth and the Therapeutic Goods Administration (TGA) will continue providing regulation and registration support for digital medical software companies looking to commercialise new products that can help improve health outcomes for Australian patients.
The highly acclaimed program has so far benefited over 1,000 industry members through 25 sold-out workshops and 350 hours of 1:1 training, with companies saying the training program has increased their ability to navigate Software as a Medical Device (SaMD) registration and regulations for new digital health technologies.
ANDHealth CEO and Managing Director Bronwyn Le Grice said: This joint initiative between ANDHealth and the TGA will enable another 400 digital health industry participants to accelerate the commercialisation of new health products, by accessing direct advice and training about the regulatory parameters pertaining to their clinical grade medical software.
