Changes made by manufacturers to software used for medical purposes already on the market in Singapore must be made known to regulators, even if they are considered insignificant, according to new guidance from the country’s Health Sciences Authority (HSA).
The direction from the HSA was part of a series of clarifications released by the regulatory agency in October of rules the agency first published in May. The agency acknowledges in the clarifications that changes may be reasonably made to software by developers on a regular basis to correct faults, improve functionality and performance, and ensure safety. But for such software, the new guidance seeks to make clear that even small changes must be assessed by regulators, and not solely by manufacturers, especially with regard to safety.
In general, a notification should be submitted to the HSA no later than six months after changes are implemented. Manufacturers are responsible for maintaining accurate and complete records of changes and for understanding the magnitude of changes. To help manufacturers understand the scope of the regulations, the HSA has published a series of charts on specific requirements related to changes in operating systems, the additions of new features or functions, and changes in software algorithms, among other aspects of the software.