The Therapeutic Goods Administration (TGA) has opened consultation on the use of software as a medical device (SaMD) as part of the International Medical Device Regulators Forum working group (IMDRF Working Group).
The IMDRF Working Group comprises a number of clinical evaluators of medical devices and is seeking views on questions relating to the clinical evaluation of SaMD products, the level of clinical evidence required for SaMD and independent review of SaMD products. Principally, the IMDRF Working Group is seeking convergent views, globally, on the principles for demonstrating safety, effectiveness and performance of SaMD products.
The SaMD products are grouped by what, from the information provided by the SaMD product, the product is intended to do in clinical management, and by the conditions in which it is intended to be used.
Consultation closes on 2 December 2017.
Source:
https://www.tga.gov.au/consultation/consultation-software-medical-device-samd-clinical-evaluation