Medical software has emerged as a significant gray area in the medical regulatory landscape. Traditionally, most medical software products have been marketed in conjunction with other hardware devices, such as CT and MRI machines, and were registered and regulated together. In recent years, there have been a growing number of ‘standalone medical software’ products that are marketed without hardware. As standalone software become increasingly sophisticated, performing functions ranging from disease diagnostics to vital sign measurement and healthcare management, a number of regulatory bodies have begun to draft separate guidelines for standalone medical software in order to ensure quality control, expedite product approval, and improve patient access to new technologies.
In October 2016, the United States Food and Drug Administration (FDA) issued a draft guidance on “Software as a Medical Device” (SaMD) in conjunction with the International Medical Device Regulators Forum (IMDRF). In July 2017, the FDA announced the ‘Software Precertification Pilot Program’ to streamline the approval process for a select number of medical software companies.
In September 2015, the European Commission (EC) issued a guidance paper for determining the status of standalone medical software. The new regulation means that standalone software could be classified as a medical device, IVD, or non-device depending upon its usage. In July 2016, the EC updated its guiding principles for classifying medical software (MEDDEV) to clarify the status of standalone software.
Standalone software is now being regulated in some Asian markets too.
In November 2014, Japan’s Pharmaceuticals and Medical Device Act (PMD) act came into effect, replacing the Pharmaceutical Affairs Law (PAL). Unlike previous regulations, in which software was only registered as a component of a medical device, the new PMD provides new regulations for standalone medical software. Standalone software products are regulated as medical devices in Japan, although Class 1 standalone medical software products are not regulated.
In August 2015, the China Food and Drug Administration (CFDA) issued the “Guiding Principles for the Technical Examination of Software Registration for Medical Devices”. Under the new guidelines, medical software, including standalone software, must be registered as a medical device. Currently, most medical software for functions such as data analysis or image processing are Class 2, while software used for surgical care or therapy treatment will be regulated as Class 3. The application process for software will be similar to that for devices, although different testing standards and documentation may be required.
The Association of South East Asian Nations (ASEAN) has pushed to integrated medical device regulations across its 10 member states of Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
In 2015, all ASEAN member states signed the Medical Devices Directive, which deemed standalone medical software as a medical device. However, this agreement will only come into effect in 2020, and for now member states will continue to have separate regulations until then.
For example, the Vietnam Ministry of Health (MOH) defines both standalone software and software used in association with other hardware as medical devices. However, there are regulatory exemptions for some standalone software products. In Vietnam, if standalone software can be installed via an internet portal, it does not need registration. However, if software is brought into Vietnam as a CD, it does require regulation.
South Korea’s Ministry of Food and Drug Safety (MFDS) has yet to implement separate regulations for standalone medical software.
India’s Ministry of Health and Family Welfare (MoHFW) has yet to implement separate regulations for standalone medical software in the 2017 Medical Device Rules.
Malaysia’s Ministry of Health (MoH) has separate regulations for medical software. According to the “Guidance on the Classification of Medical Device”, medical software used alongside medical devices will be classified according to the device’s intended use. Standalone software is also classified as a standard medical device.
The Singapore Health Sciences Authority’s ‘Guidance on Grouping of Medical Devices for Product Registration’ includes medical software within its definition of medical devices. However, if software does not fit into the definition of a medical device based on its intended use, then it may not need to be registered.
Thailand’s Food and Drug Administration (FDA) has yet to implement separate regulations for medical software. The Thailand FDA includes software in its definition of medical devices, which will be classified and regulated as such. Right now, standalone software does not require registration.
The Philippines Food and Drug Administration (FDA) has yet to implement separate regulations for standalone medical software.
Indonesia’s Ministry of Health (MoH) has yet to implement separate regulations for standalone medical software.